Publications by authors named "Mouen A Khashab"

492 Publications

Through-the-scope suture closure of peroral endoscopic myotomy mucosal incision sites.

Endoscopy 2022 Aug 4. Epub 2022 Aug 4.

Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore Maryland, United States.

BACKGROUND : Peroral endoscopic myotomy (POEM) is now widely used for esophageal motility disorders including achalasia. Closure of the mucosal incision site is a critical step of the procedure. We evaluated the use of a novel through-the-scope (TTS) suture system for closure of POEM mucosal incision sites. METHODS : We retrospectively reviewed consecutive patients who underwent POEM with TTS suture closure at our institution between February and July 2021. Technical success was defined as complete mucosal incision site closure using TTS suturing, without the need for adjunctive devices. Continuous variables are presented as median (interquartile range [IQR]) or mean (SD). RESULTS : 35 consecutive patients (median age 58 years [IQR 46.5-72]; 54.3 % female) underwent POEM with attempted mucosal closure by TTS suturing. Technical success was achieved in 32 patients (91.4 %) with a mean closure time of 12.4 (SD 6.9) minutes. The median mucosal incision length at time of closure was 2.5 cm (IQR 2-2.5). Overall, 17 patients (53.1 %) required ≥ 2 TTS suture systems and 3 patients (8.6 %) required additional TTS clips to achieve secure mucosal closure. No adverse events were encountered. CONCLUSIONS : TTS suturing was effective and safe for POEM mucosotomy closure. However, prospective comparative trials and cost-effectiveness analyses are warranted before routine adoption.
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http://dx.doi.org/10.1055/a-1890-4917DOI Listing
August 2022

Rectal INdomethacin, oral TacROlimus, or their combination for the prevention of post-ERCP pancreatitis (INTRO Trial): Protocol for a randomized, controlled, double-blinded trial.

Pancreatology 2022 Jul 19. Epub 2022 Jul 19.

Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.

Background: Acute pancreatitis remains the most common and morbid complication of endoscopic retrograde cholangiopancreatography (ERCP). The use of rectal indomethacin and pancreatic duct stenting has been shown to reduce the incidence and severity of post-ERCP pancreatitis (PEP), but these interventions have limitations. Recent clinical and translational evidence suggests a role for calcineurin inhibitors in the prevention of pancreatitis, with multiple retrospective case series showing a reduction in PEP rates in tacrolimus users.

Methods: The INTRO trial is a multicenter, international, randomized, double-blinded, controlled trial. A total of 4,874 patients undergoing ERCP will be randomized to receive either oral tacrolimus (5 mg) or oral placebo 1-2 h before ERCP, and followed for 30 days post-procedure. Blood and pancreatic aspirate samples will also be collected in a subset of patients to quantify tacrolimus levels. The primary outcome of the study is the incidence of PEP. Secondary endpoints include the severity of PEP, ERCP-related complications, adverse drug events, length of hospital stay, cost-effectiveness, and the pharmacokinetics, pharmacodynamics, and pharmacogenomics of tacrolimus immune modulation in the pancreas.

Conclusions: The INTRO trial will assess the role of calcineurin inhibitors in PEP prophylaxis and develop a foundation for the clinical optimization of this therapeutic strategy from a pharmacologic and economic standpoint. With this clinical trial, we hope to demonstrate a novel approach to PEP prophylaxis using a widely available and well-characterized class of drugs.

Trial Registration: NCT05252754, registered on February 14, 2022.
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http://dx.doi.org/10.1016/j.pan.2022.07.008DOI Listing
July 2022

Gastric peroral endoscopic myotomy for gastroparesis: making sense of the pros.

Gastrointest Endosc 2022 Jul 15. Epub 2022 Jul 15.

Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland, USA.

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http://dx.doi.org/10.1016/j.gie.2022.05.005DOI Listing
July 2022

EUS-directed transgastric ERCP in Roux-en-Y gastric bypass revision of sleeve gastrectomy.

VideoGIE 2022 Jul 21;7(7):247-249. Epub 2022 May 21.

Johns Hopkins Medicine, Baltimore, Maryland.

Video 1EUS-directed transgastric ERCP in Roux-en-Y gastric bypass revision of sleeve gastrectomy.
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http://dx.doi.org/10.1016/j.vgie.2022.04.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9264139PMC
July 2022

An international experience with single-operator cholangiopancreatoscopy in patients with altered anatomy.

Endosc Int Open 2022 Jun 10;10(6):E898-E904. Epub 2022 Jun 10.

Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland, United States.

The utility of digital single- operator cholangiopancreatoscopy (D-SOCP) in surgically altered anatomy (SAA) is limited. We aimed to evaluate the technical success and safety of D-SOCP in patients SAA. Patients with SAA who underwent D-SOCP between February 2015 and June 2020 were retrospectively evaluated. Technical success was defined as completing the intended procedure with the use of D-SOCP. Thirty-five patients underwent D-SOCP (34 D-SOC, 1 D-SOP). Bilroth II was the most common type of SAA (45.7 %), followed by Whipple reconstruction (31.4 %). Twenty-three patients (65.7 %) patients had prior failed ERCP due to the presence of complex biliary stone (52.2 %). A therapeutic duodenoscope was utilized in the majority of the cases (68.6 %), while a therapeutic gastroscope (22.7 %) or adult colonoscope (8.5 %) were used in the remaining procedures. Choledocholithiasis (61.2 %) and pancreatic duct calculi (3.2 %) were the most common indications for D-SOCP. Technical success was achieved in all 35 patients (100 %) and majority (91.4 %) requiring a single session. Complex interventions included electrohydraulic or laser lithotripsy, biliary or pancreatic stent placement, stricture dilation, and target tissue biopsies. Two mild adverse events occurred (pancreatitis and transient bacteremia). In SAA, D-SOCP is a safe and effective modality to diagnose and treat complex pancreatobiliary disorders, especially in cases where standard ERCP attempts may fail.
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http://dx.doi.org/10.1055/a-1794-0331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9187392PMC
June 2022

Role of gastric per-oral endoscopic myotomy (G-POEM) in post-lung transplant patients: a multicenter experience.

Endosc Int Open 2022 Jun 10;10(6):E832-E839. Epub 2022 Jun 10.

Johns Hopkins Hospital, Division of Gastroenterology and Hepatology, Baltimore, Maryland, United States.

Gastroparesis post-lung transplant (LTx) can lead to increased risk of gastroesophageal reflux (GER) and accelerated graft dysfunction. We aimed to evaluate the efficacy and safety of gastric per-oral endoscopic myotomy (G-POEM), a promising tool in patients with refractory gastroparesis, for managing refractory gastroparesis and GER in post-LTx patients. This was a multicenter retrospective study on post-LTx patients who underwent G-POEM for management of gastroparesis and GER that were refractory to standard medical therapy. The primary outcome was clinical success post-G-POEM. Secondary outcomes included the rate of post-G-POEM objective esophageal pH exam normalization, rate of gastric emptying scintigraphy (GES) normalization, technical success, and adverse events. A total of 20 patients (mean age 54.7 ± 14.1 years, Female 50 %) underwent G-POEM at a median time of 13 months (interquartile range 6.5-13.5) post-LTx. All G-POEM procedures were technically successful. Clinical success was achieved in 17 (85 %) patients during a median follow-up time of 8.9 (IQR: 3-17) months post-G-POEM. Overall GCSI and two of its subscales (bloating and postprandial fullness/early satiety) improved significantly following G-POEM. Two patients (10 %) developed post-procedural AEs (delayed bleeding 1, pyloric stenosis 1, both moderate in severity). Post-G-POEM GES improvement was achieved in 12 of 16 patients (75 %). All 20 patients were on proton pump inhibitors pre-G-POEM, as opposed to five post-G-POEM. Post-G-POEM PH study normalization was noted in nine of 10 patients (90 %) who underwent both pre- and post-G-poem pH testing. G-POEM is a promising noninvasive therapeutic tool for management of refractory gastroparesis and GER post-LTx.
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http://dx.doi.org/10.1055/a-1797-9587DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9187381PMC
June 2022

Biliary Endoscopy in Altered Anatomy.

Gastrointest Endosc Clin N Am 2022 Jul 11;32(3):563-582. Epub 2022 May 11.

Department of Gastroenterology & Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard treatment of biliary disease with high success rates of greater than 90% in patients with standard anatomy. However, alterations in upper gastrointestinal anatomy can significantly complicate endoscopic biliary intervention. The past decade has seen significant advances in the endoscopic management of patients with altered anatomy. This review article will provide tips and tricks for successful biliary access in the most common surgical alterations with a focus on the management of biliary diseases following Roux-en-Y (RY) reconstructions.
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http://dx.doi.org/10.1016/j.giec.2022.02.001DOI Listing
July 2022

EUS-directed transgastric interventions in Roux-En-Y Gastric Bypass anatomy: a multicenter experience.

Gastrointest Endosc 2022 May 24. Epub 2022 May 24.

Johns Hopkins Medicine, Baltimore, MD, United States.

Background And Aims: Placement of a Lumen Apposing Metal Stent (LAMS) between the gastric pouch and the excluded stomach allows for EUS Guided Transgastric Interventions (EDGI) in patients with Roux-en-Y gastric bypass (RYGB). Although EUS guided transgastric ERCP (EDGE) outcomes have been reported, there is a paucity of data on other endoscopic interventions. We aimed to evaluate the outcomes and safety of EDGI.

Methods: This is a retrospective study involving 9 centers (8 USA, 1 Europe) and included patients with RYGB who underwent EDGI between 06/2015 and 09/2021. The primary outcome was the technical success of EDGI. Secondary outcomes included adverse events, length of hospital stay, and fistula follow-up and management.

Results: 54 EDGI procedures were performed in 47 patients (mean age 61yr, F 72%), most commonly for the evaluation of a pancreatic mass (n=16) and management of pancreatic fluid collections (n=10). A 20mm LAMS was utilized in 26 patients and a 15mm LAMS in 21, creating a gastrogastrostomy (GG) in 37 patients and jejunogastrostomy (JG) in 10. Most patients (n=30, 64%) underwent a dual-session EDGI, with a median interval of 17d between the 2 procedures. Single-session EDGI was performed in 17 patients, of whom 10 (59%) had anchoring of the LAMS. The most common interventions were diagnostic EUS (+/-FNA/B) (n=28) and EUS-guided cystgastrostomy (n=8). The mean procedural time was 97.6 ± 78.9 mins. Technical success was achieved in 52 (96%). AEs occurred in 5 (10.6%) patients, of which only 1 (2.1%) was graded as severe. Intraprocedural LAMS migration was the most common AE, occurring in 3 patients (6.4%), while delayed spontaneous LAMS migration occurred in 2 (4.3%). 4 of the 5 LAMS migration events were managed endoscopically, and one required surgical repair. LAMS anchoring was found to be protective against LAMS migration (p=0.001). The median duration of hospital stay was 2.1 ± 3.7d. Of the 17 patients who underwent objective fistula assessment endoscopically/radiologically after LAMS removal, 2 (11.7%) were found to have persistent fistulas. In one case the fistula was intentionally left open to assist with weight gain. The other fistula was successfully closed endoscopically.

Conclusion: EDGI is effective and safe for the diagnosis and management of pancreatobiliary and foregut disorders in RYGB patients. It is associated with high rates of technical success and low rates of severe AEs. LAMS migration is the most common AE with evidence that anchoring can be protective against its occurrence. Persistent fistulas may occur, but endoscopic closure seems effective.
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http://dx.doi.org/10.1016/j.gie.2022.05.008DOI Listing
May 2022

Generalizability challenges of a machine learning model for classification of indeterminate biliary strictures.

Gastrointest Endosc 2022 06;95(6):1283-1284

Department of Gastroenterology and Hepatology, The Johns Hopkins University, Baltimore, Maryland, USA.

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http://dx.doi.org/10.1016/j.gie.2021.12.041DOI Listing
June 2022

Closing the Gap: Applications, Tips, and Tricks for a Novel Through-the-Scope Suturing Device.

Am J Gastroenterol 2022 07 17;117(7):1022-1027. Epub 2022 Feb 17.

Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore Maryland, USA.

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http://dx.doi.org/10.14309/ajg.0000000000001693DOI Listing
July 2022

Role of functional luminal imaging probe in the management of postmyotomy clinical failure.

Gastrointest Endosc 2022 07 9;96(1):9-17.e3. Epub 2022 Feb 9.

Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, USA.

Background And Aims: A small percentage of patients with esophageal dysmotility disorders (EDDs) fail to improve or relapse after management by laparoscopic Heller myotomy (LHM) and peroral endoscopic myotomy (POEM). In this study, we aimed to describe the role of functional luminal imaging probe (FLIP) in identifying patients who might benefit from lower esophageal sphincter (LES)-directed retreatment.

Methods: This was a retrospective study at 6 tertiary care centers (United States, 4; Europe, 1; Asia, 1) between January 2015 and April 2021 involving patients with prior failed myotomy. The primary outcome was the impact of the use of FLIP on the management of patients with prior failed myotomy.

Results: One hundred twenty-three patients (62 women [50%]; mean age, 53 ± 21.1 years) who underwent LHM (n = 53, 43%) or POEM (n = 70, 57%) for the management of achalasia (n = 98) or other EDDs (n = 25) had clinical failure at a median time of 10.8 months (interquartile range, .8-17.3) postprocedure. Twenty-nine patients had apposing "abnormal" diagnoses in terms of integrated relaxation pressure (IRP) >15 mm Hg on HRM and distensibility index (DI) <2.8 mm/mm Hg on FLIP, with ultimate change in management noted in 15 patients (10 directed toward conservative management, 5 directed toward LES-directed retreatment). The impact of FLIP on both diagnosis and management was noted in 15 of 29 patients (52%). In the subgroup analysis of 44 patients who underwent LES-directed retreatment, clinical success was highest among patients with both abnormal IRP and DI (21/25 [84%]) versus patients with only abnormal IRP (8/14 [57%]) or only abnormal DI (3/5 [60%], P = .04), with DI at 40-mL distension volume on FLIP identified as an independent predictor of clinical success (odd ratio, 1.51; 95% confidence interval, 1.02-2.1; P = .03).

Conclusions: The finding of this study further suggests the important role of using FLIP in addition to HRM in evaluating patients with clinical failure postmyotomy.
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http://dx.doi.org/10.1016/j.gie.2022.02.002DOI Listing
July 2022

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review.

Endoscopy 2022 03 3;54(3):310-332. Epub 2022 Feb 3.

Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

1:  ESGE recommends a prolonged course of a prophylactic broad-spectrum antibiotic in patients with ascites who are undergoing therapeutic endoscopic ultrasound (EUS) procedures.Strong recommendation, low quality evidence. 2:  ESGE recommends placement of partially or fully covered self-expandable metal stents during EUS-guided hepaticogastrostomy for biliary drainage in malignant disease.Strong recommendation, moderate quality evidence. 3:  ESGE recommends EUS-guided pancreatic duct (PD) drainage should only be performed in high volume expert centers, owing to the complexity of this technique and the high risk of adverse events.Strong recommendation, low quality evidence. 4:  ESGE recommends a stepwise approach to EUS-guided PD drainage in patients with favorable anatomy, starting with rendezvous-assisted endoscopic retrograde pancreatography (RV-ERP), followed by antegrade or transmural drainage only when RV-ERP fails or is not feasible.Strong recommendation, low quality evidence. 5:  ESGE suggests performing transduodenal EUS-guided gallbladder drainage with a lumen-apposing metal stent (LAMS), rather than using the transgastric route, as this may reduce the risk of stent dysfunction.Weak recommendation, low quality evidence. 6:  ESGE recommends using saline instillation for small-bowel distension during EUS-guided gastroenterostomy.Strong recommendation, low quality evidence. 7:  ESGE recommends the use of saline instillation with a 19G needle and an electrocautery-enhanced LAMS for EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) procedures.Strong recommendation, low quality evidence. 8:  ESGE recommends the use of either 15- or 20-mm LAMSs for EDGE, with a preference for 20-mm LAMSs when considering a same-session ERCP.Strong recommendation, low quality evidence.
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http://dx.doi.org/10.1055/a-1738-6780DOI Listing
March 2022

Antegrade Pancreatoscopy With Electrohydraulic Lithotrypsy Through an Endoscopic Ultrasound-Guided Pancreaticogastrostomy for the Removal of Obstructing Pancreatic Stones.

Am J Gastroenterol 2022 05 25;117(5):713-714. Epub 2022 Jan 25.

Department of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland, USA.

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http://dx.doi.org/10.14309/ajg.0000000000001654DOI Listing
May 2022

Endoscopic through-the-scope suturing.

VideoGIE 2022 Jan 9;7(1):46-51. Epub 2021 Nov 9.

Johns Hopkins Medical Institutions, Baltimore, Maryland.

Background And Aims: There is growing interest in closure of larger mucosal defects, given the increasing use of endoscopic resection for early GI neoplasia and the advent of submucosal endoscopy, including peroral endoscopic myotomy. Existing closure methods include through-the-scope clips, over-the-scope clips, and over-the-scope suturing. Although over-the-scope clips and over-the-scope suturing allow closure of large defects, both require endoscope removal for device application and may have difficulty in treating lesions in the proximal colon or the small intestine. Hence, a significant gap exists for a through-the-scope device capable of closing larger defects. The novel X-Tack system (Apollo Endosurgery, Austin, Tex, USA) offers through-the-scope suturing (TTSS), which eliminates the need to withdraw the endoscope from the patient before applying therapy.

Methods: We demonstrate the possible indications for endoscopic mucosal adhesion with TTSS through a video case series. We present 5 cases to illustrate the use of TTSS in the closure of a duodenal EMR defect, a cecal EMR defect, mucostomy after esophageal and gastric peroral endoscopic myotomy, and, finally, for primary closure of a gastrogastric fistula.

Results: All defects were successfully closed with 1 to 2 TTSS systems. There were no postprocedure adverse events, including bleeding or perforation, at a median of 30 (range 14-30) days of follow-up.

Conclusions: TTSS is a valuable addition to mucosal closure devices, which allows closure through a gastroscope or a colonoscope, without requiring endoscope removal for device application. Likely applications include larger or more distant defects and those located within tight spaces. Pending further clinical evaluation, important areas for research include assessment of the learning curve, comparative trials with other closure devices, and cost-effectiveness analysis.
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http://dx.doi.org/10.1016/j.vgie.2021.08.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8755647PMC
January 2022

Cholangioscopy-guided double-guidewire technique for complex malignant hilar obstruction.

VideoGIE 2022 Jan 30;7(1):36-37. Epub 2021 Oct 30.

Department of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland.

Video 1Cholangioscopy-guided double-guidewire technique for the management of complex malignant hilar obstruction.
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http://dx.doi.org/10.1016/j.vgie.2021.10.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8755521PMC
January 2022

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

Endoscopy 2022 02 22;54(2):185-205. Epub 2021 Dec 22.

Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.

1: ESGE recommends the use of endoscopic ultrasound-guided biliary drainage (EUS-BD) over percutaneous transhepatic biliary drainage (PTBD) after failed endoscopic retrograde cholangiopancreatography (ERCP) in malignant distal biliary obstruction when local expertise is available.Strong recommendation, moderate quality evidence. 2: ESGE suggests EUS-BD with hepaticogastrostomy only for malignant inoperable hilar biliary obstruction with a dilated left hepatic duct when inadequately drained by ERCP and/or PTBD in high volume expert centers.Weak recommendation, moderate quality evidence. 3: ESGE recommends that EUS-guided pancreatic duct (PD) drainage should only be considered in symptomatic patients with an obstructed PD when retrograde endoscopic intervention fails or is not possible.Strong recommendation, low quality evidence. 4: ESGE recommends rendezvous EUS techniques over transmural PD drainage in patients with favorable anatomy owing to its lower rate of adverse events.Strong recommendation, low quality evidence. 5: ESGE recommends that, in patients at high surgical risk, EUS-guided gallbladder drainage (GBD) should be favored over percutaneous gallbladder drainage where both techniques are available, owing to the lower rates of adverse events and need for re-interventions in EUS-GBD.Strong recommendation, high quality of evidence. 6: ESGE recommends EUS-guided gastroenterostomy (EUS-GE), in an expert setting, for malignant gastric outlet obstruction, as an alternative to enteral stenting or surgery.Strong recommendation, low quality evidence. 7: ESGE recommends that EUS-GE may be considered in the management of afferent loop syndrome, especially in the setting of malignancy or in poor surgical candidates. Strong recommendation, low quality evidence. 8: ESGE suggests that endoscopic ultrasound-directed transgastric ERCP (EDGE) can be offered, in expert centers, to patients with a Roux-en-Y gastric bypass following multidisciplinary decision-making, with the aim of overcoming the invasiveness of laparoscopy-assisted ERCP and the limitations of enteroscopy-assisted ERCP.Weak recommendation, low quality evidence.
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http://dx.doi.org/10.1055/a-1717-1391DOI Listing
February 2022

Zenker's diverticulum: advancing beyond the tunnel.

VideoGIE 2021 Dec 15;6(12):562-567. Epub 2021 Sep 15.

Johns Hopkins Medical Institutions, Baltimore, Maryland.

Background And Aims: Zenker's diverticulum (ZD) is attributed to a poorly compliant cricopharyngeus muscle, and the mainstay of treatment is a cricopharyngeal myotomy. We present a video series summarizing endoscopic treatment options for ZD and related conditions.

Methods: We review the rationale and key technique for various endoscopic treatment modalities for ZD, cricopharyngeal bar, and other esophageal diverticula.

Results: Standard flexible endoscopic cricopharyngeal myotomy involves the division of the common wall or septum of the ZD, aiming for complete transection of the cricopharyngeus. However, recurrence rates are high, likely owing to incomplete myotomy. Zenker's peroral endoscopic myotomy (Z-POEM) uses a proximal submucosal tunnel to provide direct visualization of the cricopharyngeus and septum, allowing confirmation of complete myotomy. We demonstrate an over-the-septum modification to simplify the technique. Submucosal fibrosis, commonly seen in patients with prior treatment, limits submucosal dissection. We present a hybrid technique to overcome this, whereby a traditional septotomy is performed until submucosal tissue is visualized. The intact mucosal flap after Z-POEM in a large ZD may contribute to residual dysphagia. We propose Z-POEM with mucosotomy for large ZD. Finally, we demonstrate modifications for treatment of other esophageal diseases, including cricopharyngeal bar and non-Zenker's esophageal diverticula.

Conclusion: Endoscopic treatment options for ZD and related conditions are rapidly expanding. With careful tailoring to individual patient characteristics, our expanding arsenal of options allows effective and safe treatment of a broad spectrum of patients.
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http://dx.doi.org/10.1016/j.vgie.2021.08.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8646134PMC
December 2021

Prophylactic appendiceal retrograde intraluminal stent placement (PARIS).

VideoGIE 2021 Dec 14;6(12):552-554. Epub 2021 Oct 14.

Johns Hopkins Hospital, Department of Gastroenterology and Hepatology, Baltimore, Maryland.

Video 1Video of the prophylactic appendiceal retrograde intraluminal stent placement technique.
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http://dx.doi.org/10.1016/j.vgie.2021.09.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8646081PMC
December 2021

Pilot prospective study on formal training in per-oral endoscopic myotomy (POEM) during advanced endoscopy fellowship.

Endosc Int Open 2021 Dec 14;9(12):E1890-E1899. Epub 2021 Dec 14.

Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida, United States.

 Gastroenterology societies have recently proposed core curricula for training in per-oral endoscopic myotomy (POEM) based on expert opinion with limited data on its applicability for advanced endoscopy fellowship (AEF) trainees. We prospectively evaluated the feasibility of a structured POEM training curriculum during a dedicated AEF and the trainee's performance during independent practice. This was a single-center prospective study evaluating a trainee's performance of POEM using a structured assessment tool (POEMAT) to assess core cognitive and technical skills. The trainee's performance was then prospectively assessed during the first 12 months of independent practice. The trainee, who had not prior background in submucosal endoscopy, first observed 22 POEM cases followed by 35 hands-on procedures during his advanced endoscopy fellowship. Based on the POEMAT, submucosal entry and mucosal incision closure were the most challenging technical aspects, while cognitive skills were uniformly attained early in training. Overall, the trainee was able to cross the threshold for competence in his POEMAT performance score in 15 of his last 18 cases (83.3 %). The trainee performed 16 POEMs (baseline mean Eckardt 7.2) in his first 12 months of independent practice. Mean procedural time was 79.8 minutes (interquartile range: 67-94 minutes minutes) with no adverse events. Clinical success (Eckardt score < 3) was achieved in 100 % of the cases at a median follow-up of 20 weeks. Results from this pilot study support the adoptability of the recently proposed core curricula for POEM training within the context of a dedicated AEF and provide a potential blueprint for future studies of performance in POEM among trainees.
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http://dx.doi.org/10.1055/a-1610-8962DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8671003PMC
December 2021

Submucosal tunnelling techniques for Zenker's diverticulum: a systematic review of early outcomes with pooled analysis.

Eur J Gastroenterol Hepatol 2021 12;33(1S Suppl 1):e78-e83

Gastroenterology Department, Endoscopy Unit, Humanitas Clinical and Research Center -IRCCS.

In the last decade, flexible endoscopic septotomy has been reported as a well-tolerated and effective treatment for Zenker's diverticulum. More recently, novel endoscopic submucosal tunneling techniques, namely Zenker-PerOral Endoscopic Myotomy (Z-POEM) and PerOral Endoscopic Septotomy (POES) have been proposed to obtain complete muscular septum exposure and deeper myotomy. The aim of this study is to provide a systematic review with a meta-analysis of the first experiences of third space approaches for Zenker's diverticulum. Electronic databases (Medline, Scopus, EMBASE) were searched up to October 2020. Studies including patients with symptomatic Zenker's diverticulum who underwent endoscopic treatment by submucosal tunneling technique were eligible. Procedural, clinical and safety outcomes were assessed by pooling data with a random-effect model to obtain a proportion with a 95% confidence interval. Nine retrospective studies were eligible for inclusion (196 patients). Five studies were performed in the USA, two in Europe and two in Asia. Endoscopic treatment was feasible in 96.9% (I2 = 0%) of patients. The mean procedure duration was 36.4 ± 14.3 minutes. Clinical success was achieved after 93.4% (I2 = 0%) of procedures. The overall adverse events rate was 4.9% (I2 = 0%). No differences between the two approaches (Z-POEM vs POES) have been shown in terms of both efficacy and safety. Submucosal tunneling techniques appear to be feasible for symptomatic Zenker's diverticulum, with promising results in terms of efficacy and safety outcomes.
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http://dx.doi.org/10.1097/MEG.0000000000002318DOI Listing
December 2021

Novel 15-mm-long lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections located ≥10 mm from the luminal wall.

Endoscopy 2022 Jul 14;54(7):706-711. Epub 2021 Dec 14.

Department of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland, United States.

Background:  Endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) by cautery-enhanced lumen-apposing metal stents (LAMS) has largely been limited to collections located < 10 mm from the luminal wall. We present outcomes of the use of a novel 15-mm-long cautery-enhanced LAMS for drainage of PFCs located ≥ 10 mm away.

Methods:  This international, multicenter study analyzed all adults with PFCs located ≥ 10 mm from the luminal wall who were treated by EUS-guided drainage using the 15-mm-long cautery-enhanced LAMS. The primary outcome was technical success. Secondary outcomes included clinical success (decrease in PFC size by ≥ 50 % at 30 days and resolution of clinical symptoms without surgical intervention), complications, and recurrence.

Results:  35 patients (median age 57 years; interquartile range [IQR] 47-64 years; 49 % male) underwent novel LAMS placement for drainage of PFCs (26 walled-off necrosis, 9 pseudocysts), measuring 85 mm (IQR 64-117) maximal diameter and located 11.8 mm (IQR 10-12.3; range 10-14) from the gastric/duodenal wall. Technical and clinical success were high (both 97 %), with recurrence in one patient (3 %) at a median follow-up of 123 days (58-236). Three complications occurred (9 %; one mild, two moderate).

Conclusions:  The 15-mm-long cautery-enhanced LAMS was feasible and safe for drainage of PFCs located 10-14 mm from the luminal wall.
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http://dx.doi.org/10.1055/a-1682-7095DOI Listing
July 2022

Early cholangioscopy-assisted electrohydraulic lithotripsy in difficult biliary stones is cost-effective.

Therap Adv Gastroenterol 2021 23;14:17562848211031388. Epub 2021 Jul 23.

Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Glen Site, 1001 Décarie Blvd., Montreal, QC H4A 3J1, Canada.

Background And Aims: Single-operator cholangioscopy-assisted electrohydraulic lithotripsy (SOC-EHL) is effective and safe in difficult choledocholithiasis. The optimal timing of SOC-EHL use, however, in refractory stones has not been elucidated. The following aims to determine the most cost-effective timing of SOC-EHL introduction in the management of choledocholithiasis.

Methods: A cost-effectiveness model was developed assessing three strategies with a progressively delayed introduction of SOC-EHL. Probability estimates of patient pathways were obtained from a systematic review. The unit of effectiveness is complete ductal clearance without need for surgery. Cost is expressed in 2018 US dollars and stem from outpatient US databases.

Results: The three strategies achieved comparable ductal clearance rates ranging from 97.3% to 99.7%. The least expensive strategy is to perform SOC-EHL during the first endoscopic retrograde cholangiography pancreatography (ERCP) (SOC-1: 18,506$). The strategy of postponing the use of SOC-EHL to the third ERCP (SOC-3) is more expensive (US$18,895) but is 2% more effective. (0.9967). SOC-EHL during the second ERCP in the model (SOC-2) is the least cost-effective. Sensitivity analyses show altered conclusions according to the cost of SOC-EHL, effectiveness of conventional ERCP, and altered willingness-to-pay (WTP) thresholds with early SOC-1 being the most optimal approach below a WTP cut-off of US$20,295.

Conclusions: Early utilization of SOC-EHL (SOC-1) in difficult choledocholithiasis may be the least costly strategy with an effectiveness approximating those achieved with a delayed approach where one or more conventional ERCP(s) are reattempted prior to SOC-EHL introduction.
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http://dx.doi.org/10.1177/17562848211031388DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8600178PMC
July 2021

Durability of per-oral endoscopic myotomy beyond 6 years.

Endosc Int Open 2021 Nov 12;9(11):E1595-E1601. Epub 2021 Nov 12.

Division of Gastroenterology and Hepatology Johns Hopkins Hospital, Baltimore, USA.

 The aim of this study was to assess long-term clinical outcomes beyond 6 years in patients who underwent per-oral endoscopic myotomy (POEM) for the treatment of achalasia.  Patients with achalasia who underwent POEM between 2010 and 2012 and had follow-up of at least 6 years were retrospectively identified at eight tertiary care centers. The primary outcome evaluated was clinical success defined by an Eckardt symptom score (ESS) ≤ 3 for the duration of the follow-up period. The clinical success cohort was compared to failure (ESS > 3 at any time during follow-up) in order to identify characteristics associated with symptom relapse. The incidence of patient-reported gastroesophageal reflux (GER) was also evaluated.  Seventy-three patients with 6-year follow-up data were identified. Sustained clinical remission was noted in 89 % (65/73) at 6-years. Mean ESS decreased from 7.1 ± 2.3 pre-procedure to 1.1 ± 1.1 at 6 years (  < 0.001). Symptomatic reflux was reported by 27 of 72 patients (37.5 %). Type I achalasia (OR 10.8,  = 0.04) was found to be associated with clinical failure on logistic regression analysis.  In patients with achalasia, POEM provides high initial clinical success with excellent long-term outcomes. There are high rates of patient-reported gastroesophageal reflux post-procedure which persist at long-term follow-up.
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http://dx.doi.org/10.1055/a-1553-9846DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8589554PMC
November 2021

Early infection is an independent risk factor for increased mortality in patients with culture-confirmed infected pancreatic necrosis.

Pancreatology 2022 Jan 9;22(1):67-73. Epub 2021 Nov 9.

Institute for Translational Medicine, Medical School, University of Pecs, Pecs, Hungary.

Background: Mortality in infected pancreatic necrosis (IPN) is dynamic over the course of the disease, with type and timing of interventions as well as persistent organ failure being key determinants. The timing of infection onset and how it pertains to mortality is not well defined.

Objectives: To determine the association between mortality and the development of early IPN.

Methods: International multicenter retrospective cohort study of patients with IPN, confirmed by a positive microbial culture from (peri) pancreatic collections. The association between timing of infection onset, timing of interventions and mortality were assessed using Cox regression analyses.

Results: A total of 743 patients from 19 centers across 3 continents with culture-confirmed IPN from 2000 to 2016 were evaluated, mortality rate was 20.9% (155/734). Early infection was associated with a higher mortality, when early infection occurred within the first 4 weeks from presentation with acute pancreatitis. After adjusting for comorbidity, advanced age, organ failure, enteral nutrition and parenteral nutrition, early infection (≤4 weeks) and early open surgery (≤4 weeks) were associated with increased mortality [HR: 2.45 (95% CI: 1.63-3.67), p < 0.001 and HR: 4.88 (95% CI: 1.70-13.98), p = 0.003, respectively]. There was no association between late open surgery, early or late minimally invasive surgery, early or late percutaneous drainage with mortality (p > 0.05).

Conclusion: Early infection was associated with increased mortality, independent of interventions. Early surgery remains a strong predictor of excess mortality.
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http://dx.doi.org/10.1016/j.pan.2021.11.003DOI Listing
January 2022

Switching the switch: endoscopic reversal of a biliopancreatic diversion.

VideoGIE 2021 Oct 10;6(10):464-467. Epub 2021 Jul 10.

Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland.

Video 1Schematic representation and endoscopic video of an endoscopic duodenal switch reversal.
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http://dx.doi.org/10.1016/j.vgie.2021.06.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8551544PMC
October 2021

Peroral endoscopic myotomy for management of cricopharyngeal bars (CP-POEM): a retrospective evaluation.

Endoscopy 2022 05 28;54(5):498-502. Epub 2021 Oct 28.

Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland, United States.

Background: Cricopharyngeal bars (CPBs) are a unique etiology of oropharyngeal dysphagia. Symptomatic patients are managed with endoscopic dilation or surgical myotomy. Cricopharyngeal peroral endoscopic myotomy (CP-POEM) is an emerging technique for the management of dysphagia due to CPBs. This study evaluated technical success, clinical success, adverse events, and long-term recurrence following CP-POEM.

Methods: Consecutive patients who underwent POEM for management of CPBs between May 2015 and December 2020 at four tertiary care centers were included. Primary outcome was clinical success (defined as improvement of dysphagia score to ≤ 1). Secondary outcomes were technical success, rate and severity of adverse events, procedure duration, and symptom recurrence.

Results: 27 patients (mean age 69 years; 10 female) underwent CP-POEM during the study period. The most common presenting symptoms at the time of index procedure were dysphagia (26; 96.3 %) and regurgitation (20; 74.1 %). Clinical and technical success were achieved in all patients. Mild/moderate adverse events occurred in two patients (7.4 %). CP-POEM significantly reduced the median dysphagia score.

Conclusions: CP-POEM was a safe and effective treatment for symptomatic CPBs. Although symptom recurrence was low, long-term outcome data are needed. CP-POEM should be considered as a management option for symptomatic CPBs at centers with POEM expertise.
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http://dx.doi.org/10.1055/a-1646-1151DOI Listing
May 2022

Commentary.

Endoscopy 2021 11 26;53(11):1191. Epub 2021 Oct 26.

Johns Hopkins Medicine, Baltimore, Maryland, United States.

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http://dx.doi.org/10.1055/a-1543-3315DOI Listing
November 2021

Initial multicenter experience using a novel endoscopic tack and suture system for challenging GI defect closure and stent fixation (with video).

Gastrointest Endosc 2022 Feb 22;95(2):373-382. Epub 2021 Oct 22.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.

Background And Aims: Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips, or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult-to-reach defects. Thus, we aimed to assess the feasibility and safety of a novel through-the-scope, suture-based closure system developed to overcome these limitations.

Methods: This was a retrospective multicenter study involving 8 centers in the United States. Primary outcomes were feasibility and safety of early use of the device. Secondary outcomes were assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s).

Results: Ninety-three patients (48.4% women) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%), and supplemental closure was required in 24.7% of patients (n = 23) with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients because of location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range, 13-93.5) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred.

Conclusions: The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large and irregularly shaped defects that were not possible with established devices.
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http://dx.doi.org/10.1016/j.gie.2021.10.018DOI Listing
February 2022

Impact of genetic testing and smoking on the distribution of risk factors in patients with recurrent acute and chronic pancreatitis.

Scand J Gastroenterol 2022 Jan 18;57(1):91-98. Epub 2021 Oct 18.

Pancreatitis Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.

Objective: The aim of the present study is to assess the impact of smoking dose and duration on the distribution of risk factor(s) in patients with RAP and CP, and the impact of genetic testing on the distribution of risk factor(s) in patients with idiopathic RAP and CP.

Methods: All adult patients with RAP and CP referred to a multidisciplinary pancreatitis clinic between 2010 and 2017 were evaluated. Risk factors included alcohol and smoking, hypertriglyceridemia, biliary, and other etiologies. Genetic testing was only pursued in patients with idiopathic RAP or CP.

Results: Among the 1770 patients evaluated, 167 had RAP and 303 had CP. After genetic testing and smoking, the most common risk factors for RAP and CP were pathogenic variant(s) (23%) and the combination of alcohol and smoking (23%), respectively. Genetic testing and smoking assessment decreased the proportion of patients with alcoholic RAP from 17% to 5%, alcoholic CP from 33% to 10%, idiopathic RAP from 49% to 12%, and idiopathic CP from 54% to 14%. Pathogenic CFTR variants were the most common variant in patients with RAP (51%) and CP (43%). Among the 68 patients with pancreas divisum, other risk factor(s) were identified in 72%.

Conclusion: Genetic testing and a detailed assessment of smoking dose and duration reduce the proportion of patients with alcoholic and idiopathic pancreatitis. Other risk factor(s) for pancreatitis are found in the majority of patients with pancreas divisum further questioning its role as an independent risk factor.1. What is the current knowledge?Approximately 30% of patients with pancreatitis have no clear risk factor(s) and are categorized as having an idiopathic etiology.Pathogenic variant(s) as well as smoking dose and duration are well-established risk factors for recurrent acute and chronic pancreatitis but are not widely recognized or incorporated into clinical practice.2. What is new here?Genetic testing and a detailed assessment of smoking dose and duration reduced the proportion of patients with alcoholic and idiopathic acute recurrent and chronic pancreatitis.Approximately three-fourths of patients with pancreas divisum have a risk factor for pancreatitis.
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http://dx.doi.org/10.1080/00365521.2021.1984573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9278560PMC
January 2022
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