Publications by authors named "Perry Shen"

199 Publications

Defining the Risk of Early Recurrence Following Curative-Intent Resection for Distal Cholangiocarcinoma.

Ann Surg Oncol 2021 Mar 11. Epub 2021 Mar 11.

Division of Surgical Oncology, Health Services Management and Policy, Department of Surgery, The Urban Meyer III and Shelley Meyer Chair for Cancer Research, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH, USA.

Background: Although multidisciplinary treatments including the use of adjuvant therapy (AT) have been adopted for biliary tract cancers, patients with distal cholangiocarcinoma (DCC) can still experience recurrence. We sought to characterize the incidence and predictors of early recurrence (ER) that occurred within 12 months following surgery for DCC.

Patients And Methods: Patients who underwent resection for DCC between 2000 and 2015 were identified from the US multi-institutional database. Cox regression analysis was used to identify clinicopathological factors to develop an ER risk score, and the predictive model was validated in an external dataset.

Results: Among 245 patients included in the analysis, 67 patients (27.3%) developed ER. No difference was noted in ER rates between patients who did and did not receive AT (28.7% vs. 25.0%, p = 0.55). Multivariable analysis revealed that neutrophil-to-lymphocyte ratio (NLR), peak total bilirubin (T-Bil), major vascular resection (MVR), lymphovascular invasion, and R1 surgical margin status were associated with a higher ER risk. A DIstal Cholangiocarcinoma Early Recurrence Score was developed according to each factor available prior to surgery [NLR > 9.0 (2 points); peak T-bil > 1.5 mg/dL (1 points); MVR (2 points)]. Cumulative ER rates incrementally increased among patients who were low (0 points; 10.6%), intermediate (1-2 points; 26.8%), or high (3-5 points; 57.6%) risk (p < 0.001) in the training dataset, as well as in the validation dataset [low (0 points); 3.4%, intermediate (1-2 points); 32.7%, or high risk (3-5 points); 55.6% (p < 0.001)].

Conclusions: Among patients undergoing resection for DCC, 1 in 4 patients experienced an ER. Alternative treatment strategies such as neoadjuvant chemotherapy may be considered especially among individuals deemed to be at high risk for ER.
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http://dx.doi.org/10.1245/s10434-021-09811-4DOI Listing
March 2021

Identification of patients who may benefit the most from adjuvant chemotherapy following resection of incidental gallbladder carcinoma.

J Surg Oncol 2021 Mar 26;123(4):978-985. Epub 2021 Jan 26.

Department of Surgery, Wexner Medical Center, The Ohio State University, Columbus, Ohio, USA.

Background: To develop a scoring system to identify the subset of patients who may benefit the most from adjuvant chemotherapy following curative-intent resection for incidental gallbladder cancer (IGBC).

Methods: A novel scoring system was utilized to stratify patients relative to overall survival (OS), as well as potential benefit from adjuvant chemotherapy following curative resection for IGBC.

Results: Among 266 patients with IGBC, a total of 99 (37.2%) patients received adjuvant chemotherapy. Five risk factors were used to develop an integer-based score to predict OS. Risk of death at 5-years incrementally increased among patients in the low (n = 42, 69.0%), medium (n = 64, 56.3%) and high-risk groups (n = 40, 30.0%) (median OS, 99.4 vs. 33.5 vs. 15.6 months, all p < .001). Use of adjuvant chemotherapy did not provide a survival benefit among patients in the low-risk group (median survival, 99.4 vs. 60.7 months, p = .56). In contrast, utilization of adjuvant chemotherapy was associated with an improvement in survival among medium- (median survival, 21.7 vs. 59.5 months, p = .04) and high-risk patients (median survival, 11.6 vs. 20.1 months, p = .01).

Conclusions: While low-risk patients did not benefit from adjuvant chemotherapy, individuals with medium or high-risk scores had an improved survival with the utilization of adjuvant chemotherapy.
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http://dx.doi.org/10.1002/jso.26389DOI Listing
March 2021

Prognostic Impact and Utility of Immunoprofiling in the Selection of Patients with Colorectal Peritoneal Carcinomatosis for Cytoreductive Surgery (CRS) and Heated Intraperitoneal Chemotherapy (HIPEC).

J Gastrointest Surg 2021 01 2;25(1):233-240. Epub 2020 Dec 2.

John Wayne Cancer Institute, Providence St. John's Medical Center, 2200 Santa Monica Boulevard, Santa Monica, CA, USA.

Background: Recent studies have shown an association in non-metastatic colorectal cancer between patient survival and immunoprofiling (expression of CD3, CD4, CD8, CD45, and FOXP3 T cells at the invasive margin (IM) and the tumor center (TC)) regardless of stage. Patients with peritoneal carcinomatosis have a dismal prognosis, but survival can be significantly improved in selected patients who undergo cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). However, current patient selection for CRS/HIPEC is suboptimal. The purpose of this study is to evaluate immune profiles of patients with peritoneal carcinomatosis and their correlation with overall survival (OS).

Methods: The study cohort included patients from a prospectively maintained database of adults with colorectal peritoneal carcinomatosis who underwent CRS/HIPEC. Immunohistochemistry (IHC) using antibodies to CD3, CD4, CD8, CD45RO, and FOXP3 T cells was performed. IHC image density was calculated using ImageJ software, and an immunoscore was determined.

Results: Eighty tumors were evaluated from 66 patients. These included 14 primary sites and 66 metastatic sites. R0/R1 resection was achieved in 44 (66.7%) patients. Known prognostic factors including resection status (HR 1.99, p = 0.004) and lymph node status (HR 3.49, p = 0.002) were associated with overall survival. On multivariate analysis, increased CD3/CD4 IM (HR 0.54, p = 0.03) ratio positively was associated with improved OS.

Discussion: This is the first study to assess the utility of subtypes of T cells as prognostic markers in patients with colorectal peritoneal carcinomatosis, which may play a role in patients with low-volume disease. Further studies into immune mechanisms may improve patient selection for cytoreductive surgery and HIPEC as well as provide novel pathways for effective immunotherapy.
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http://dx.doi.org/10.1007/s11605-020-04886-yDOI Listing
January 2021

Quality analysis of operative reports and referral data for appendiceal neoplasms with peritoneal dissemination.

Surgery 2021 04 12;169(4):790-795. Epub 2020 Nov 12.

Surgical Oncology Service, Department of General Surgery, Wake Forest University, Winston-Salem, NC. Electronic address:

Background: Peritoneal metastasis from appendiceal neoplasms is a rare disease usually found unexpectedly and is associated with deficits in quality reporting of findings.

Methods: Retrospective review of our appendiceal peritoneal metastases carcinomatosis database evaluating quality of index operative and pathology reports. Operative report quality was graded by 2 standards; general quality, based on Royal College of Surgeons quality metrics and peritoneal metastases assessment. Pathology report quality was assessed by the accuracy of diagnosis.

Results: Three hundred and seventy-five index operative reports and 490 outside pathology reports were reviewed. General quality of the index operative reports was excellent, with nearly 80% of reports encompassing all the Royal College of Surgeons quality metrics. Peritoneal metastases assessment was poor. Forty-four percent of the reports performed no peritoneal evaluation, while 48.3% only involved partial peritoneal evaluation. Only 7.7% of the reports performed a complete evaluation. Of the pathology reports, 48.4% had discrepancies with final pathologic findings. Low-grade disease and high-grade disease were misdiagnosed 36.06% and 62.7% of the time, respectively. Discordant treatment occurred in 15.3% and 30.0% of cases for misdiagnosed low-grade and high-grade disease, respectively. Incomplete cytoreduction was attempted in nearly a third of referral cases, which was associated with a significantly increased risk for ultimate incomplete cytoreduction with an odds ratio of 4.72.

Conclusion: This review finds that referral operative reports' descriptions of the technical aspects of a procedure is usually complete. However, oncologic parameters and descriptions of peritoneal metastases are frequently incomplete. Further, pathology reports from outside institutions can lead to inappropriate clinical management decisions. We propose a simplified algorithm to assist nonperitoneal surface malignancy surgeons.
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http://dx.doi.org/10.1016/j.surg.2020.10.001DOI Listing
April 2021

Utilization of chemoradiation therapy provides strongest protective effect for avoidance of postoperative pancreatic fistula following pancreaticoduodenectomy: A NSQIP analysis.

J Surg Oncol 2020 Dec 15;122(8):1604-1611. Epub 2020 Sep 15.

Department of Surgical Oncology, Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, USA.

Background: The utilization of neoadjuvant therapy (NAT) before performing pancreaticoduodenectomy for malignancy has been well established as a protective factor for the prevention of postoperative pancreatic fistula (POPF). However, there is a paucity of published data evaluating the specific NAT regimen that is the most protective against POPF development. We evaluated the differences between neoadjuvant chemotherapy (CT) and chemoradiation therapy (CRT) with regard to the effect on POPF rates.

Methods: The main and targeted pancreatectomy American College of Surgeons National Surgical Quality Improvement Program registries for 2014-2016 were retrospectively reviewed. A total of 10,665 pancreaticoduodenectomy cases were present. The primary outcome was POPF development. The factors that have previously been shown to be associated with or suspected to be associated with POPF were evaluated. The factors included NAT, sex, age, body mass index (BMI), diabetes, smoking, steroid therapy, preoperative weight loss, preoperative albumin level, perioperative blood transfusions, wound classification, American Society of Anesthesiologists classification, duct size (<3 mm, 3-6 mm, and >6 mm), gland texture (soft, intermediate, and hard), and anastomotic technique. The factors identified to be statistically significant were then used for propensity score matching to compare POPF development between the cases utilizing CT versus CRT.

Results: A total of 10,117 cases met the inclusion criteria. The development of POPF was significantly associated, on multivariate analysis, with a lack of NAT, male sex, higher BMI, nondiabetic status, nonsmoker status, decreased weight loss, preoperative albumin level, decreased duct size, and soft gland texture. NAT, duct size, and gland texture had the strongest associations with the development of POPF (p < .0001). The overall 1765 cases (17.45%) received NAT and the POPF rate for cases with NAT was 10.20% versus 20.10% for cases without NAT (p < .0001). A total of 1031 cases underwent CT and 734 cases underwent CRT, respectively. A total of 708 paired cases were selected for analysis based on propensity score matching. The POPF rates were 11.20% versus 3.50% for CT and CRT, respectively (p < .0001). There was no difference in the frequencies of specific POPF grades. The decreased POPF rate with CRT correlated with firmer gland texture rates.

Conclusions: To our knowledge, this is the largest analysis of specific NAT regimens with regard to the development of POPF following pancreaticoduodenectomy. CRT provided the strongest protective effect. That protective effect is most likely due to increased fibrosis in the pancreatic parenchyma from radiation therapy. These findings provide additional support to consider CRT over CT alone in the treatment of pancreatic cancer when NAT will be utilized.
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http://dx.doi.org/10.1002/jso.26202DOI Listing
December 2020

Defining and Predicting Early Recurrence after Resection for Gallbladder Cancer.

Ann Surg Oncol 2021 Jan 5;28(1):417-425. Epub 2020 Sep 5.

Division of Surgical Oncology, Department of Surgery, The Urban Meyer III and Shelley Meyer Chair for Cancer Research, James Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Background: The optimal time interval to define early recurrence (ER) among patients who underwent resection of gallbladder cancer (GBC) is not well defined. We sought to develop and validate a novel GBC recurrence risk (GBRR) score to predict ER among patients undergoing resection for GBC.

Patients And Methods: Patients who underwent curative-intent resection for GBC between 2000 and 2018 were identified from the US Extrahepatic Biliary Malignancy Consortium database. A minimum p value approach in the log-rank test was used to define the optimal cutoff for ER. A risk stratification model was developed to predict ER based on relevant clinicopathological factors and was externally validated.

Results: Among 309 patients, 103 patients (33.3%) had a recurrence at a median follow-up period of 15.1 months. The optimal cutoff for ER was defined at 12 months (p = 3.04 × 10). On multivariable analysis, T3/T4 disease (HR: 2.80; 95% CI 1.58-5.11) and poor tumor differentiation (HR: 1.91; 95% CI 1.11-3.25) were associated with greater hazards of ER. The GBRR score was developed using β-coefficients of variables in the final model, and patients were classified into three distinct groups relative to the risk for ER (12-month RFS; low risk: 88.4%, intermediate risk: 77.9%, high risk: 37.0%, p < 0.001). The external validation demonstrated good model generalizability with good calibration (n = 102: 12-month RFS; low risk: 94.2%, intermediate risk: 59.8%, high risk: 42.0%, p < 0.001). The GBRR score is available online at https://ktsahara.shinyapps.io/GBC_earlyrec/ .

Conclusions: A novel online calculator was developed to help clinicians predict the probability of ER after curative-intent resection for GBC. The proposed web-based tool may help in the optimization of surveillance intervals and the counselling of patients about their prognosis.
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http://dx.doi.org/10.1245/s10434-020-09108-yDOI Listing
January 2021

Clinical Implications of Genetic Signatures in Appendiceal Cancer Patients with Incomplete Cytoreduction/HIPEC.

Ann Surg Oncol 2020 Dec 23;27(13):5016-5023. Epub 2020 Jul 23.

Breast Cancer Center of Excellence, Wake Forest Baptist Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Introduction: Clinical decision-making is challenging in patients who undergo cytoreductive surgery/hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) when complete cytoreduction is not feasible. Nevertheless, some patients still benefit with long-term survival after incomplete CRS/HIPEC. There is currently no robust predictive tool that can assist clinical decision-making in this setting.

Methods: We quantified gene expression of 79 appendiceal mucinous neoplasms (AMN) from patients with incomplete CRS/HIPEC (R2 resection) using a custom NanoString gene panel. Using our previously defined, prognostic subtype classification algorithm based on signed nonnegative matrix factorization, we classified AMN cases into three molecular subtypes termed: immune enriched (IE), mixed (M), and oncogene enriched (OE). Kaplan-Meier and Cox proportional hazards analyses were used to associate subtypes and individual genes with overall survival (OS).

Results: Median overall survival (OS) was 7.7 years for IE, 3.6 years for M, and 1.4 years for OE. Compared with IE, OE was associated with significantly lower survival [hazard ratio (HR) 3.64, 95% confidence interval (CI) 1.63-8.13; p = 0.0017]. The differences were observed in both low-grade and high-grade tumors. While only two genes were identified to be associated with OS in low-grade tumors, multiple genes were identified to be associated with OS in high-grade tumors, particularly genes with functions in cell cycle/proliferation, mucin production, immune pathways, and cell adhesion/migration.

Conclusion: Genetic signatures have prognostic value in patients with incomplete cytoreduction and provide valuable information to assist clinical and operative decision-making. Unraveling genetic alterations and involved pathways can direct efforts to design novel therapeutic modalities.
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http://dx.doi.org/10.1245/s10434-020-08841-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7674220PMC
December 2020

Personalized Identification of Optimal HIPEC Perfusion Protocol in Patient-Derived Tumor Organoid Platform.

Ann Surg Oncol 2020 Dec 6;27(13):4950-4960. Epub 2020 Jul 6.

Wake Forest Organoid Research Center (WFORCE), Wake Forest School of Medicine, Winston-Salem, NC, USA.

Background: Chemotherapy dosing duration and perfusion temperature vary significantly in HIPEC protocols. This study investigates patient-derived tumor organoids as a platform to identify the most efficacious perfusion protocol in a personalized approach.

Patients And Methods: Peritoneal tumor tissue from 15 appendiceal and 8 colon cancer patients who underwent CRS/HIPEC were used for personalized organoid development. Organoids were perfused in parallel at 37 and 42 °C with low- and high-dose oxaliplatin (200 mg/m over 2 h vs. 460 mg/m over 30 min) and MMC (40 mg/3L over 2 h). Viability assays were performed and pooled for statistical analysis.

Results: An adequate organoid number was generated for 75% (6/8) of colon and 73% (11/15) of appendiceal patients. All 42 °C treatments displayed lower viability than 37 °C treatments. On pooled analysis, MMC and 200 mg/m oxaliplatin displayed no treatment difference for either appendiceal or colon organoids (19% vs. 25%, p = 0.22 and 27% vs. 31%, p = 0.55, respectively), whereas heated MMC was superior to 460 mg/m oxaliplatin in both primaries (19% vs. 54%, p < 0.001 and 27% vs. 53%, p = 0.002, respectively). In both appendiceal and colon tumor organoids, heated 200 mg/m oxaliplatin displayed increased cytotoxicity as compared with 460 mg/m oxaliplatin (25% vs. 54%, p < 0.001 and 31% vs. 53%, p = 0.008, respectively).

Conclusions: Organoids treated with MMC or 200 mg/m heated oxaliplatin for 2 h displayed increased susceptibility in comparison with 30-min 460 mg/m oxaliplatin. Optimal perfusion protocol varies among patients, and organoid technology may offer a platform for tailoring HIPEC conditions to the individual patient level.
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http://dx.doi.org/10.1245/s10434-020-08790-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7674215PMC
December 2020

Surgical drain placement in distal pancreatectomy is associated with an increased incidence of postoperative pancreatic fistula and higher readmission rates.

J Surg Oncol 2020 Jul 2. Epub 2020 Jul 2.

Division of Surgical Oncology Winston-Salem, Department of General Surgery, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.

Background: Postoperative pancreatic fistula (POPF) can result in significant morbidity after distal pancreatectomy (DP). It is common practice to place prophylactic surgical drains during DP to monitor and minimize POPF complications; however, their use is controversial.

Objective: The aim of this study is to determine if drainage helps to prevent adverse outcomes and decrease the need for additional interventions after DP.

Methods: All patients who underwent DP without vascular resection were identified in the 2014 Targeted Pancreatectomy American College of Surgeons National Surgery Quality Improvement Program Participant Use File. Patients undergoing emergency procedures, American Society of Anesthesiology (ASA) 5, or diagnosed with preoperative sepsis were excluded. Univariate and multiple variable analyses were performed to evaluate postoperative outcomes based on use of surgical drain.

Results: A total of 1158 patients (age median: 62; interquartile range: 16; female 58.6%) underwent elective DP with 85.1% (n = 985) having drain placed at time of operation. Laparoscopic technique was used in the majority of patients (54.1%, n = 619). POPF occurred in 201 patients (17.5%). Additional percutaneous drain was required in 106 patients (9.2%). POPF was higher in surgical drain group, 19.4% vs 6.9% (P < .001). Need for percutaneous drain was similar between drain and no drain groups, 9.3% vs 8.1% (P = .600). Postoperative sepsis, shock, major complication, reoperation, and 30-day mortality was similar between drain and no drain groups (all P > .05). However, readmission was higher in the surgical drain group, 17.8% vs 10.4% (odds ratio [OR]: 1.9; 95% confidence interval [CI]: 1.1-3.1; P = .018). After adjusting for age, ASA, and operative time, readmission remained higher in the surgical drain group (OR: 1.9; 95% CI: 1.1-3.2; P = .016).

Conclusion: The use of surgical drainage during DP was associated with increased incidence of readmission and POPF. Drainage showed no effect on outcomes of postoperative sepsis, shock, major complications, reoperation, and 30-day mortality. Based on these results, routine prophylactic drainage should be reconsidered for patients undergoing DP.
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http://dx.doi.org/10.1002/jso.26072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7775868PMC
July 2020

Caregiver Quality of Life Before and After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

J Am Coll Surg 2020 04 31;230(4):679-687. Epub 2020 Jan 31.

Surgical Oncology Service, Department of General Surgery, Wake Forest University, Winston-Salem, NC. Electronic address:

Background: Cytoreductive surgery plus intraperitoneal hyperthermic chemotherapy (CRS+HIPEC) is a formidable procedure, often affecting the quality of life (QOL) of the caregiver as well as the patient. We explored the impact of quality of life and depressive symptom burdens of CRS+HIPEC caregivers prospectively.

Study Design: Patient and caregiver dyads were both consented per IRB-approved protocol; CRS ± HIPEC was performed. The impact on QOL and depressive symptom burdens was assessed on patient-caregiver dyads via the Caregiver Quality of Life (CG QOL-C), CES-D (Center for Epidemiological Studies - Depression) instruments; pre-CS+HIPEC (T1), postoperative (T2), 6 (T3), and 12 (T4) months.

Results: Seventy-seven dyads were approached, with 73 participating. Both caregiver and patient depressive symptom trajectories changed significantly. CES-D means for caregivers were (T1-4): 15.1 (SE [standard error] 1.7), 15.0 (1.4), 10.3 (1.4), 13.1 (2.1), p = 0.0008; for patients were: 10.3 (SE 1.1), 13.7 (1.4), 9.0 (1.2), and 10.3 (1.5), p = 0.0002. Preoperatively, caregivers scored 4.8 points (SD 13.4) (p = 0.026) higher than patients. Patients experienced an increase in depression scores at the postoperative visit. At T3, both groups dropped to less concerning levels; yet caregiver CES-D scores increased again at T4 4.7 points (SD 12.5) higher than the patients, and financial well-being became worse from T1 to T3. Possible, probable, and "cases" of depression were higher for caregivers were at all measured time points.

Conclusions: Significant numbers of caregivers endured high depressive symptom burdens and financial concerns. Different caregiver-patient trajectories reflect the need for differential timing of supportive interventions. Evaluation of quality of life and impact of CRS+HIPEC procedures must move beyond assessment of only the patient.
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http://dx.doi.org/10.1016/j.jamcollsurg.2019.12.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7192323PMC
April 2020

Prognostic Molecular Classification of Appendiceal Mucinous Neoplasms Treated with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

Ann Surg Oncol 2020 May 24;27(5):1439-1447. Epub 2020 Jan 24.

Surgical Oncology Service, Department of General Surgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Background: Appendiceal mucinous neoplasm (AMN) with peritoneal metastasis is a rare but deadly disease with few prognostic or therapy-predictive biomarkers to guide treatment decisions. Here, we investigated the prognostic and biological attributes of gene expression-based AMN molecular subtypes.

Methods: AMN specimens (n = 138) derived from a population-based subseries of patients treated at our institution with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) between 05/2000 and 05/2013 were analyzed for gene expression using a custom-designed NanoString 148-gene panel. Signed non-negative matrix factorization (sNMF) was used to define a gene signature capable of delineating robustly-classified AMN molecular subtypes. The sNMF class assignments were evaluated by topology learning, reverse-graph embedding and cross-cohort performance analysis.

Results: Three molecular subtypes of AMN were discerned by the expression patterns of 17 genes with roles in cancer progression or anti-tumor immunity. Tumor subtype assignments were confirmed by topology learning. AMN subtypes were termed immune-enriched (IE), oncogene-enriched (OE) and mixed (M) as evidenced by their gene expression patterns, and exhibited significantly different post-treatment survival outcomes. Genes with specialized immune functions, including markers of T-cells, natural killer cells, B-cells, and cytolytic activity showed increased expression in the low-risk IE subtype, while genes implicated in the promotion of cancer growth and progression were more highly expressed in the high-risk OE subtype. In multivariate analysis, the subtypes demonstrated independent prediction power for post-treatment survival.

Conclusions: Our findings suggest a greater role for the immune system in AMN than previously recognized. AMN subtypes may have clinical utility for predicting CRS/HIPEC treatment outcomes.
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http://dx.doi.org/10.1245/s10434-020-08210-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7147286PMC
May 2020

Hepatic arterial infusion chemotherapy for colorectal liver metastases revisited.

HPB (Oxford) 2020 Sep 17;22(9):1265-1270. Epub 2020 Jan 17.

Division of Surgical Oncology, Wake Forest Baptist Health, USA. Electronic address:

Background: Recent reports indicate improved survival in patients undergoing surgical treatment for colorectal liver metastases (CRLM) with hepatic arterial infusion (HAI) pump chemotherapy compared to surgery alone.

Methods: Patients who underwent resection and/or ablation of CRLM between 1996 and 2016 were included from a single-institution prospectively maintained database. Proportional hazards regression analysis was performed to determine predictors of overall survival (OS) and 3:1 propensity score analysis (PSA).

Results: Of 349 patients included, 36 had HAI pumps placed (HAI group) and 313 did not (no-HAI group). There was no difference in primary tumor grade (p = 0.24), ECOG status (p = 0.44), tumor number (p = 0.1), tumor size (p = 0.56), margin status (p = 0.76) between the two groups. Median overall survival was 44.7months vs 37.1months for the HAI versus no-HAI group (p = 0.01). Cox proportional hazards regression analysis demonstrated positive margin status (HR:2.47,p < 0.0001), HAI therapy (HR:0.56,p = 0.02), preoperative chemotherapy (HR:0.69,p = 0.02) and tumor diameter (HR:1.07,p = 0.005) as predictors of OS. In 3:1 PSA, 32 HAI subjects were matched with 87 non-HAI subjects balancing all covariates. Median OS was 42.4 months versus 35.6 months for the HAI versus no-HAI group (p = 0.03).

Conclusion: Surgical treatment of CRLM combined with HAI chemotherapy is associated with improved OS compared to surgery alone. Further study of this treatment approach is indicated.
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http://dx.doi.org/10.1016/j.hpb.2019.12.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7365757PMC
September 2020

Optimal Adjuvant Treatment Approach After Upfront Resection of Pancreatic Cancer: Revisiting the Role of Radiation Based on Pathologic Features.

Ann Surg 2020 Jan 6. Epub 2020 Jan 6.

Division of Surgical Oncology, Department of Surgery, Wake Forest University, Winston Salem, NC.

Objective: To identify the survival benefit of different adjuvant approaches and factors influencing their efficacy after upfront resection of pancreatic ductal adenocarcinoma (PDAC).

Summary Background Data: The optimal adjuvant approach for PDAC remains controversial.

Methods: Patients from the National Cancer Database who underwent upfront PDAC resection from 2010 to 2014 were analyzed to determine clinical outcomes of different adjuvant treatment approaches, stratified according to pathologic characteristics. Factors associated with overall survival were identified with multivariable logistic regression and Cox proportional hazards were used to compare overall survival of different treatment approaches in the whole cohort, and propensity score matched groups.

Results: We included 16,709 patients who underwent upfront resection of PDAC. On multivariable analysis, tumor size, grade, positive margin, nodal involvement, lymphovascular invasion (LVI), stage, lymph node ratio, not receiving chemotherapy, and/or radiation were predictors for worse survival. In the presence of at least 1 high-risk pathologic feature (nodal or margin involvement or LVI) chemotherapy with subsequent radiation provided the most significant survival benefit (median survivals: 24.8 vs 21.0 mo for adjuvant chemotherapy; HR = 0.81; 95% CI: 0.77-0.86; P < 0.001 in propensity score matching). The addition of radiation to adjuvant chemotherapy did not significantly improve overall survival in those with no high-risk pathologic features (median survivals: 54.6 vs 42.7 mo for adjuvant chemotherapy; HR=0.90; 95% CI: 0.75-1.08; P = 0.25 in propensity score matching).

Conclusions: In the presence of any high-risk pathologic features (nodal or margin involvement or LVI), adjuvant chemotherapy followed by radiation provides a better survival advantage over chemotherapy alone after upfront resection of PDAC.
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http://dx.doi.org/10.1097/SLA.0000000000003770DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335684PMC
January 2020

Survival benefit of lymphadenectomy for gallbladder cancer based on the therapeutic index: An analysis of the US extrahepatic biliary malignancy consortium.

J Surg Oncol 2020 Mar 6;121(3):503-510. Epub 2020 Jan 6.

Division of Surgical Oncology, Department of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, Ohio.

Background: The survival benefit of lymphadenectomy among patients with gallbladder cancer (GBC) remains poorly understood.

Methods: Patients who underwent resection for GBC between 2000 and 2015 were identified from a US multi-institutional database. The therapeutic index (LNM rate multiplied by 3-year overall survival [OS]) was determined to assess the survival benefit of lymphadenectomy.

Results: Among 449 patients, less than half had LNM (N = 183, 40.8%). The median number of evaluated and metastatic lymph nodes (LNs) was 3 (interquartile range [IQR]: 1-6) and 1 (IQR: 0-1), respectively. 3-year OS among patients with LNM in the entire cohort was 26.8%. The therapeutic index was lower among patients with T4 (5.9) or T1 (6.0) tumors as well as carbohydrate antigen (CA19-9) ≥200 UI/mL (6.0). Of note, a therapeutic index difference ≥10 was noted relative to CA19-9 (<200: 18.7 vs ≥200: 6.0), American Joint Committee on Cancer T Stage (T1: 6.0 vs T2: 17.8 vs T4: 5.9) and number of LNs examined (1-2: 6.9 vs ≥6: 16.9). Concomitant common bile duct resection was not associated with a higher therapeutic index among patients with either T2 or T3 disease.

Conclusion: Certain clinicopathological factors including T1 or T4 tumor and CA19-9 ≥200 UI/mL were associated with a low therapeutic index. Resection of six or more LNs was associated with a meaningful therapeutic index benefit among patients with LNM.
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http://dx.doi.org/10.1002/jso.25825DOI Listing
March 2020

Feasibility of low-cost accelerometers in measuring functional recovery after major oncologic surgery.

J Surg Oncol 2019 Nov 28. Epub 2019 Nov 28.

Section of Surgical Oncology, Department of Surgery, Wake Forest Baptist Health, Winston-Salem, North Carolina.

Background And Objectives: Low-cost consumer-based activity monitors (CAMs), such as the Fitbit, are popular for fitness and wellness tracking. Functional status is an excellent predictor of postoperative outcomes, yet objective measurements are resource-intensive. The aim of this study is to demonstrate the feasibility of using activity monitors during the perioperative period in patients undergoing major oncologic surgery.

Methods: An institution review board proved that a prospective study was conducted. CAMs were worn throughout the perioperative period and accelerometer data were collected. Baseline and 21-days follow-up functional measures included short physical performance battery, Community Health Activities Model Program questionnaire, mobility assessment tool-short form, and 400 m walk.

Results: A total of 19 of 22 (86%) patients who wore a CAM during the perioperative period had analyzable data. Compliance with wearing the device varied significantly: 100% preadmission, 19% in-hospital, and 82% postdischarge. Median daily steps decreased from preadmission to postdischarge (77% median reduction). Established resource-intensive measures of functional status did not perform well as measures of decreased functional status and activity when comparing baseline to 21-day postdischarge assessments.

Conclusions: Activity monitors are a feasible, low-cost measure of perioperative activity for patients undergoing major surgery, and may be useful in identifying patients vulnerable to postsurgical complications.
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http://dx.doi.org/10.1002/jso.25789DOI Listing
November 2019

Role of Surgery for Metastatic Melanoma.

Surg Clin North Am 2020 Feb 1;100(1):127-139. Epub 2019 Nov 1.

Department of Surgery, Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston Salem, NC 27157, USA.

Complete surgical resection of metastatic melanoma has a known survival benefit. Treatment of metastatic melanoma, however, has become increasingly complex with the introduction of targeted treatments and immune checkpoint inhibitors. Integration of systemic medical therapy and surgical resection has shown promising results, with significantly improved long-term survivals. Results from current clinical trials are awaited to help further delineate the sequence and combination of systemic therapy and surgery.
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http://dx.doi.org/10.1016/j.suc.2019.09.011DOI Listing
February 2020

ASO Author Reflections: The Diminishing Role of Adjuvant HIPEC.

Ann Surg Oncol 2020 Jan 12;27(1):115-116. Epub 2019 Nov 12.

Department of Surgery, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.

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http://dx.doi.org/10.1245/s10434-019-08070-8DOI Listing
January 2020

Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin.

Ann Surg Oncol 2020 Mar 12;27(3):772-780. Epub 2019 Nov 12.

Department of Surgery, Wake Forest University, Winston Salem, NC, USA.

Background: This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin.

Methods: In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally.

Results: Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group.

Conclusions: Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC.
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http://dx.doi.org/10.1245/s10434-019-08064-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034653PMC
March 2020

ASO Author Reflections: Patient-Reported Outcomes of Mucinous Appendiceal Cancer Improve with Oxaliplatin HIPEC.

Ann Surg Oncol 2020 Mar 12;27(3):781-782. Epub 2019 Nov 12.

Department of Surgery, Wake Forest Baptist Medical Center, Winston Salem, NC, USA.

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http://dx.doi.org/10.1245/s10434-019-08066-4DOI Listing
March 2020

ASO Author Reflections: Demonstrating the Benefits of Oncology Navigation.

Ann Surg Oncol 2019 Dec 28;26(Suppl 3):840-841. Epub 2019 Oct 28.

Department of Surgery, Wake Forest Baptist Medical Center, Winston Salem, NC, USA.

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http://dx.doi.org/10.1245/s10434-019-08003-5DOI Listing
December 2019

Outcomes After Adjuvant Hyperthermic Intraperitoneal Chemotherapy for High-Risk Primary Appendiceal Neoplasms After Complete Resection.

Ann Surg Oncol 2020 Jan 31;27(1):107-114. Epub 2019 Jul 31.

Department of Surgery, Wake Forest Baptist Medical Center, Winston Salem, NC, USA.

Introduction: Appendiceal neoplasms are uncommon tumors. Optimal treatment for patients with perforation or high-grade pathology after initial resection is unknown. This study evaluated patients with increased risk for peritoneal dissemination after primary resection, but no evidence of peritoneal disease, who underwent adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC).

Methods: This multi-institutional cohort study evaluated 56 patients with high-risk (HR) appendiceal neoplasms with a peritoneal carcinomatosis index of 0 who underwent HIPEC. The patients were divided into two groups: perforated low-grade appendiceal (LGA) carcinoma and HR neoplasms, which included perforated high-grade appendiceal carcinoma, positive margins after initial resection, minimal macroscopic peritoneal disease that was previously resected or completely responded to systemic chemotherapy prior to HIPEC, goblet cell carcinoma, and adenocarcinoma with signet ring cell features. Overall survival (OS) and recurrence-free survival (RFS) were estimated by Kaplan-Meier analysis.

Results: Thirty-eight percent of patients had perforated LGA and 68% had HR features. Five-year OS probability was 82.1% for the entire cohort, and 100% and 70.1% for patients with perforated LGA and HR features, respectively (p = 0.024). Five-year RFS probability was 79.3% for the entire cohort, and 90.0% and 72.4% for patients with perforated LGA and HR features, respectively (p = 0.025). Eight patients recurred after HIPEC and their OS was significantly worse (p < 0.001).

Conclusion: While adjuvant HIPEC is both safe and feasible, there appears to be little benefit over close surveillance when outcomes are compared with historical and prospective studies, especially for perforated LGA carcinoma.
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http://dx.doi.org/10.1245/s10434-019-07634-yDOI Listing
January 2020

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for peritoneal mesothelioma: patient selection and special considerations.

Cancer Manag Res 2019 7;11:4231-4241. Epub 2019 May 7.

Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston Salem, NC 27157, USA.

Malignant peritoneal mesothelioma (MPM) is a rare, aggressive malignancy that typically presents with vague symptoms, ascites, and/or diffuse peritoneal studding. Despite findings of advanced disease within the peritoneal cavity, spread beyond the abdomen is uncommon. Although advances in systemic chemotherapy have been made, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) remain the mainstay of treatment. Median overall survival of approximately 50 months with CRS/HIPEC has been demonstrated, with age, gender, histologic subtype, peritoneal carcinomatosis index, comorbidities, nodal and extra-abdominal metastases, and completeness of cytoreduction all playing a role in prognosis. In patients with refractory malignant ascites and unresectable disease, complete resolution of ascites and improvement in quality of life have been demonstrated with palliative HIPEC. In appropriately selected patients, CRS/HIPEC plays a critical role in the treatment and palliation of MPM.
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http://dx.doi.org/10.2147/CMAR.S170300DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6511620PMC
May 2019

Evaluation of Chest Radiographs and Laboratory Testing during Melanoma Staging Procedures.

Am Surg 2019 May;85(5):505-510

Chest radiographs (CXRs) and laboratory testing have historically been performed as a part of low-risk melanoma (clinical stage 1/2) workup. This study evaluates the utility of routine CXRs and laboratory testing during the staging of clinical stage 1 and 2 melanoma patients. This study was approved by the Institutional Review Board at Wake Forest University. A database of sentinel lymph node biopsies performed for clinical stage 1 or 2 melanoma was used to identify early-stage melanoma patients. The medical records of patients with melanoma were reviewed and preoperative workup procedures were recorded. Four hundred sixty-three patients were reviewed. A total of 315 patients underwent a preoperative CXR, whereas 309 received some laboratory testing. After sentinel node biopsies, 168 patients had pathologic stage 1 disease, 103 stage 2, and 44 stage 3. None of the CXRs (0%) correctly identified metastatic melanoma. Suspicious locations on CXRs and laboratory testing did not lead to metastatic findings in any patient within a year. Metastatic melanoma was not found in any patient by screening with CXRs or laboratory testing during preoperative workup. We recommend not conducting CXRs or laboratory testing during workup for surgical melanoma patients because of charges and anxiety these tests can cause. CXRs, blood tests, and metabolic panels have historically been ordered for early melanoma patients, although debate remains on their efficacy. Surgical patient records were retrospectively reviewed for these tests and no benefit was found.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6743493PMC
May 2019

ASO Author Reflections: Demonstrating the Benefits of Oncology Navigation.

Ann Surg Oncol 2019 12 13;26(Suppl 3):608-609. Epub 2019 May 13.

Department of Surgery, Wake Forest Baptist Medical Center, Winston Salem, NC, USA.

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http://dx.doi.org/10.1245/s10434-019-07427-3DOI Listing
December 2019

Effect of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy on Quality of Life in Patients with Peritoneal Mesothelioma.

Ann Surg Oncol 2020 Jan 8;27(1):117-123. Epub 2019 May 8.

Surgical Oncology Service, Department of General Surgery, Wake Forest University, Winston-Salem, NC, USA.

Introduction: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) is an accepted treatment for peritoneal mesothelioma. In this study, we evaluated QOL after HIPEC for peritoneal mesothelioma.

Methods: This was a prospective study performed after HIPEC for peritoneal mesothelioma between 2002 and 2015. Patients completed QOL surveys, including the Short Form-36 (SF-36), Functional Assessment of Cancer Therapy + Colon (FACT-C), Brief Pain Inventory (BPI), and Center for Epidemiologic Studies Depression Scale (CES-D) preoperatively and at 3, 6, 12, and 24 months postoperatively.

Results: Overall, 46 patients underwent HIPEC for peritoneal mesothelioma and completed QOL surveys. Mean age was 52.8 ± 13.8 years and 52% were male. Good preoperative functional status was 70%. Median survival was 3.4 years, and 1, 3, and 5-year survivals were 77.4, 55.2, and 36.5%, respectively. CES-D score decreased at 3 months postoperatively, but increased at 24 months (p = 0.014); SF-36 physical functioning scale decreased at 3 months but returned to baseline at 12 months (p = 0.0045); and the general health scale decreased at 3 months, then improved by 6 months (p = 0.0034). Emotional well-being (p = 0.0051), role limitations due to emotional problems (p = 0.0006), social functioning (p = 0.0022), BPI (p = 0.025), least pain (p = 0.045), and worst pain (p < 0.0001) improved. FACT-C physical well-being decreased at 3 months but returned to baseline at 6 months (p = 0.020), and total FACT-C score improved at 6 months (p = 0.052).

Conclusion: QOL returned to baseline or improved from baseline between 3 months and 1 year following surgery. Despite the risks associated with this operation, patients may tolerate HIPEC well and have good overall QOL postoperatively.
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http://dx.doi.org/10.1245/s10434-019-07425-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6842037PMC
January 2020

Association of Perioperative Transfusion with Recurrence and Survival After Resection of Distal Cholangiocarcinoma: A 10-Institution Study from the US Extrahepatic Biliary Malignancy Consortium.

Ann Surg Oncol 2019 Jun 15;26(6):1814-1823. Epub 2019 Mar 15.

Division of Surgical Oncology, Department of Surgery, Winship Cancer Institute, Emory University, Atlanta, GA, USA.

Background: Perioperative allogeneic blood transfusion is associated with poor oncologic outcomes in multiple malignancies. The effect of blood transfusion on recurrence and survival in distal cholangiocarcinoma (DCC) is not known.

Methods: All patients with DCC who underwent curative-intent pancreaticoduodenectomy at 10 institutions from 2000 to 2015 were included. Primary outcomes were recurrence-free (RFS) and overall survival (OS).

Results: Among 314 patients with DCC, 191 (61%) underwent curative-intent pancreaticoduodenectomy. Fifty-three patients (28%) received perioperative blood transfusions, with a median of 2 units. There were no differences in baseline demographics or operative data between transfusion and no-transfusion groups. Compared with no-transfusion, patients who received a transfusion were more likely to have (+) margins (28 vs 14%; p = 0.034) and major complications (46 vs 16%; p < 0.001). Transfusion was associated with worse median RFS (19 vs 32 months; p = 0.006) and OS (15 vs 29 months; p = 0.003), which persisted on multivariable (MV) analysis for both RFS [hazard ratio (HR) 1.8; 95% confidence interval (CI) 1.1-3.0; p = 0.031] and OS (HR 1.9; 95% CI 1.1-3.3; p = 0.018), after controlling for portal vein resection, estimated blood loss (EBL), grade, lymphovascular invasion (LVI), and major complications. Similarly, transfusion of ≥ 2 pRBCs was associated with lower RFS (17 vs 32 months; p < 0.001) and OS (14 vs 29 months; p < 0.001), which again persisted on MV analysis for both RFS (HR 2.6; 95% CI 1.4-4.5; p = 0.001) and OS (HR 4.0; 95% CI 2.2-7.5; p < 0.001). The RFS and OS of patients transfused 1 unit was comparable to patients who were not transfused.

Conclusion: Perioperative blood transfusion is associated with decreased RFS and OS after resection for distal cholangiocarcinoma, after accounting for known adverse pathologic factors. Volume of transfusion seems to exert an independent effect, as 1 unit was not associated with the same adverse effects as ≥ 2 units.
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http://dx.doi.org/10.1245/s10434-019-07306-xDOI Listing
June 2019

Minimally Invasive Surgical Approaches for Peritoneal Surface Malignancy.

Surg Oncol Clin N Am 2019 04 11;28(2):161-176. Epub 2019 Jan 11.

Department of Surgery, Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston Salem, NC 27157, USA. Electronic address:

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is an evolving strategy in the locoregional management of peritoneal surface malignancies, and the role of laparoscopy is expanding. Staging laparoscopy is routinely used to obtain tissue for diagnosis and assess extent of tumor burden. Laparoscopic CRS and HIPEC with curative intent is safe and effective in patients with a low disease burden. In patients with refractory malignant ascites, complete resolution of ascites and improvement in quality of life have been demonstrated with palliative laparoscopic HIPEC. Laparoscopic CRS and HIPEC has an expanding role in the treatment of peritoneal surface disease.
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http://dx.doi.org/10.1016/j.soc.2018.11.010DOI Listing
April 2019

Effect of Negative Pressure Wound Therapy on Wound Complications Post-Pancreatectomy.

Am Surg 2019 Jan;85(1):1-7

Surgical site infection (SSI) and incisional hernia are common complications after major pancreatectomy. We investigated the effects of negative pressure wound therapy (NPWT) on short- and long-term wound outcomes in patients undergoing pancreatectomy. A randomized controlled trial comparing the effect of NPWT with standard surgical dressing (SSD) on wounds was performed in 265 patients undergoing open gastrointestinal resections from 2012 to 2016. We performed a subset analysis of 73 patients who underwent pancreatectomy. Wound complications in the first 30 days and incisional hernia rates were assessed. There were 33 (45%) female patients in the study and the average BMI was 27.6. The pancreaticoduodectomy rate was 68 per cent, whereas 27 per cent of patients underwent distal or subtotal pancreatectomy, and 4 per cent total pancreatectomy. Incisional hernia rates were 32 per cent and 14 per cent between the SSD and NPWT groups, respectively ( = 0.067). In the SSD (n = 37) and NPWT (n = 36) cohorts, the superficial SSI, deep SSI, seroma, and dehiscence rates were 16 per cent and 14 per cent ( > 0.99), 5 per cent and 8 per cent ( = 0.67), 16 per cent and 11 per cent ( = 0.74), and 5 per cent and 3 per cent ( ≥ 0.99), respectively. After adjusting for pancreatic fistula and delayed gastric emptying, no statistically significant differences in the primary outcomes were observed. These findings were true irrespective of the type of resection performed. Short- and long-term wound complications were not improved with NPWT. We observed a trend toward decreased incisional hernia rates in patients treated with NPWT. Owing to the multifactorial nature of wound complications, it is yet to be determined which cohorts of pancreatectomy patients will benefit from NPWT.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6743488PMC
January 2019