North American Expert Consensus on the Post-procedural Care of Patients After Per-oral Endoscopic Myotomy Using a Delphi Process.

BACKGROUND & AIMS: There is significant variability in the immediate post-operative and long-term management of patients undergoing per-oral endoscopic myotomy (POEM), largely stemming from the lack of high-quality evidence. We aimed to establish a consensus on several important questions on the after care of post-POEM patients through a modified Delphi process. METHODS: A steering committee developed an initial questionnaire consisting of 5 domains (33 statements): post-POEM admission/discharge, indication for immediate post-POEM esophagram, peri-procedural medications and diet resumption, clinic follow-up recommendations, and post-POEM reflux surveillance and management. A total of 34 experts participated in the 2 rounds of the Delphi process, with quantitative and qualitative data analyzed for each round to achieve consensus. RESULTS: A total of 23 statements achieved a high degree of consensus. Overall, the expert panel agreed on the following: (1) same-day discharge after POEM can be considered in select patients; (2) a single dose of prophylactic antibiotics may be as effective as a short course; (3) a modified diet can be advanced as tolerated; and (4) all patients should be followed in clinic and undergo objective testing for surveillance and management of reflux. Consensus could not be achieved on the indication of post-POEM esophagram to evaluate for leak. CONCLUSIONS: The results of this Delphi process established expert agreement on several important issues and provides practical guidance on key aspects in the care of patients following POEM.

The timing of recurrence after endoscopic papillectomy.

BACKGROUND: Endoscopic papillectomy (EP) offers a safe and effective method for resection of ampullary adenomas. Data regarding the long-term resolution of adenoma following EP are limited. The aim of this study therefore was to examine the timing of recurrence after EP of ampullary adenomas. METHODS: This was a single-center retrospective study including patients who received EP for ampullary adenomas from 8/2000 to 1/2018. Patients with confirmed complete eradication of adenoma were included in the recurrence analysis with recurrence defined as finding adenomatous histology after 1 negative surveillance endoscopy. Kaplan-Meier estimates were calculated to determine recurrence rates. RESULTS: Of the 165 patients who underwent EP, 136 patients (mean age 61.9, 51.5% female) had adenomatous histology with a mean lesion size of 21.2 mm. A total of 124 (91.2%) achieved complete eradication with a follow-up of 345.8 person-years. Recurrence occurred in 20 (16.1%) patients at a mean of 3.2 (± 3) years (range 0.5-9.75 years) for a recurrence rate of 5.8 (95% CI 3.6-8.8) per 100 person-years. Nine (45%) recurrences occurred after the 1st 2 years of surveillance. Recurrence rate did not differ by baseline pathology [low-grade dysplasia: 5.2 (95% CI 3.0-9.0), high-grade dysplasia: 6.9 (95% CI 2.3-15.5), adenocarcinoma: 7.7 (95% CI 0.9-25.1)]. CONCLUSION: Recurrence remains a significant concern after EP. Given the timing of recurrence, long surveillance periods may be necessary. Larger multicenter studies are needed, however, to determine appropriate surveillance intervals.

Direct cost variance analysis of peroral endoscopic myotomy vs heller myotomy for management of achalasia: A tertiary referral center experience.

BACKGROUND: Laparoscopic Heller myotomy (LHM) has been the traditional surgical treatment for achalasia. Recently, peroral endoscopic myotomy (POEM) has demonstrated similar clinical outcomes with shorter procedure times. Studies comparing the direct cost-effectiveness of POEM vs LHM are limited. AIM: To compare costs of POEM vs LHM. METHODS: This retrospective chart review aimed to compare the outcomes and cost of clinical care between patients who underwent POEM and LHM procedures for achalasia. The study was conducted at a tertiary academic center from January 2019 to December 2020. Clinical outcomes, including post-operative Eckardt scores and adverse events, were assessed and compared between the two groups. Direct cost variance analysis was utilized to evaluate the cost of clinical care incurred by patients undergoing POEM in the year preceding the procedure, during the index admission, and one year post-procedure, in comparison to patients undergoing LHM. RESULTS: Of 30 patients were included (15 POEM and 15 LHM) in the study. Patients in the POEM group had a mean Eckardt score of 0.5 ± 0.5 post-procedure, which was no different from patients in the LHM group (0.7 ± 0.6, P = 0.17) indicating comparative efficacy. However, the total costs of the admission for the procedure in the LHM group were on average $1827 more expensive than in the POEM group (P < 0.01). Total healthcare costs one year prior to index procedure were $7777 higher in the LHM group, but not statistically different (P = 0.34). The patients in the LHM group one year after the index procedure had accrued $19730.24 larger total cost, although this was not statistically different from POEM group (P = 0.68). CONCLUSION: Despite similar clinical outcomes, the cost of the index procedure admission for POEM was significantly lower than for LHM. The difference was primarily related to shorter time increments utilized in the operating room during the index procedure, and shorter length of hospital stay following POEM.

Role of short interval FLIP panometry in predicting long-term outcomes after per-oral endoscopic myotomy.

BACKGROUND: The Eckardt score (ES) is used to assess symptom response to Per-Oral Endoscopic Myotomy (POEM), but reliable methods to assess physiologic success are needed. Functional lumen imaging probe (FLIP) panometry has a potential role in post-POEM follow-up to predict long-term outcomes. The aim of this study was to assess the correlation between clinical success and FLIP parameters following POEM to determine if short interval FLIP could predict long-term outcomes. METHODS: This was a prospective study of adult patients who underwent POEM with short interval follow-up FLIP between 11/2017 and 3/2020. Clinical success was defined as post-procedure ES ≤ 3. Physiologic success was based on an esophago-gastric junction distensibility index (EGJ-DI) > 2.8 mm2/mmHg on FLIP. RESULTS: 47 patients (55% female, mean age 55 years) were included in the study. Clinical success after POEM was seen in 45 (96%) patients (mean ES 6.5 ± 2.2 pre and 0.83 ± 1.0 post-POEM, p < 0.001). Physiologic success was noted in 43 (91.5%) patients (mean EGJ-DI 6.1 mm2/mmHg ± 2.5). Among 4 patients not meeting criteria for physiologic success, EGJ-DI was 2.5-2.6. There was no correlation between post-POEM EGJ-DI and ES in the short term or long term. Significant reflux esophagitis was seen in 6 (12.8%) patients with no difference in mean EGJ-DI with vs without esophagitis (5.9 vs 6.1, p = 0.44). CONCLUSION: Post-POEM endoscopy with FLIP is useful to both assess EGJ physiology and to examine for reflux esophagitis. Short interval FLIP has limited utility to predict long-term patient outcomes or risk of acid reflux.

Recent advances and current challenges in endoscopic resection with the full-thickness resection device.

Endoscopic full-thickness resection (EFTR) has emerged as a viable technique in the management of mucosal and subepithelial lesions of the gastrointestinal tract (GIT) not amenable to conventional therapeutic approaches. While various devices and techniques have been described for EFTR, a single, combined full-thickness resection and closure device (full-thickness resection device, FTRD system, Ovesco Endoscopy AG, Tuebingen, Germany) has become commercially available in recent years. Initially, the FTRD system was limited to use in the colorectum only. Recently, a modified version of the FTRD has been released for EFTR in the upper GIT as well. This review provides a broad summary of the FTRD, highlighting recent advances and current challenges.

Comparison of Zenker's per-oral endoscopic myotomy (Z-POEM) with standard flexible endoscopic septotomy for Zenker's diverticulum: a prospective study with 2-year follow-up.

BACKGROUND: Flexible endoscopic therapy of Zenker's diverticulum using submucosal tunneling (Z-POEM) similar to esophageal Per-Oral Endoscopic Myotomy (POEM) is becoming increasingly common. However, data comparing Z-POEM with traditional flexible endoscopic septotomy (FES) are sparse. The aim of this study was to compare outcomes of Z-POEM with traditional FES over a medium-term follow-up period. METHODS: This was a prospective study of patients who underwent Z-POEM for treatment of Zenker's diverticulum between 2018 and 2020 at a tertiary academic medical center compared to prior patients who had FES (between 2015 and 2018). Procedural characteristics and clinical outcomes (technical and clinical success, and adverse events) were compared between patients who underwent each treatment. RESULTS: A total of 28 patients underwent ZD therapy during the study period. 13 patients (mean age 70 years; 77% male) underwent Z-POEM and 15 patients (mean age 72 years; 73% male) underwent traditional FES. The mean Zenker's diverticulum size was 2.4 ± 0.6 cm in the ZPOEM group vs 2.5 ± 0.8 cm in the FES group. The mean procedure time was similar between groups: 43.9 min (range 26-66) in the Z-POEM group and 60.2 min (range 25-92) in the traditional FES group (t = 1.74 p = 0.19). Overall technical success was seen in 100% of patients. There was one adverse event in the FES group (dehydration resulting in near-syncope) (1/28, 3.6%). Overall clinical success was seen in 92.8% (26/28) of patients and was not significantly different between groups (Z-POEM; 13/13, 100% vs FES; 13/15, 86.7%, t = - 1.36 p = 0.18). CONCLUSION: This prospective study suggests that ZPOEM is an effective technique for the treatment of Zenker's diverticulum with no significant differences in clinical outcomes or adverse event rates when compared to traditional FES.

Comparison of the Efficacy and Safety of the FDA-approved Intragastric Balloon Systems in a Clinical Setting.

BACKGROUND AND AIMS: The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved IGB systems to treat obesity; however, they have not been previously compared in clinical practice. The aims of this study were to compare their efficacy, tolerance, and safety in a clinical setting. MATERIALS AND METHODS: This is a retrospective cohort study of consecutive patients treated with the gas-filled IGB or fluid-filled IGB between October 2015 and May 2020 at 2 academic centers. The primary endpoints included percent total body weight loss at balloon removal in patients who completed at least 20 weeks of therapy, the difference in adverse events that required urgent evaluation or hospitalization, and early removal in the 2 groups. RESULTS: A total of 87 patients underwent successful IGB placement (gas-filled IGB n=57, age 48.9±8.8, body mass index 35.5±5 kg/m 2 ; fluid-filled IGB n=30, age 49.2±14.3, body mass index 38.8±6 kg/m 2 ). Eleven patients underwent early device removal. There were no differences in percent total body weight loss at balloon removal and 12 months between the balloon systems ( P =0.39). Patients who received the fluid-filled IGB were more likely to require urgent evaluation or treatment, require hospital stay >24 hours, and need early balloon system removal compared with patients treated with the gas-filled IGB. CONCLUSION: In this 2-center cohort, both FDA-approved gastric balloon systems had the same effectiveness, but the gas-filled IGB had fewer serious adverse events and better tolerability than the fluid-filled IGB.

Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.

OBJECTIVE: We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection. SUMMARY BACKGROUND DATA: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. DESIGN: We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events. RESULTS: Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths. CONCLUSIONS: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.