Sharma, Neil

INTRODUCTION: The study aimed to develop consensus recommendations for the safe and appropriate use of liquid nitrogen spray cryotherapy in Barrett's esophagus and esophageal cancer. METHODS: Statements were initially formulated and grouped into categories of indications, training, preprocedure, intraprocedure, and postprocedure recommendations, frequency/timing of repeat procedures, and contraindications. Two investigators assessed the strength of the evidence for each statement using Grading of Recommendations Assessment, Development, and Evaluation methodology. Nineteen experts were invited to participate in a modified Delphi process. For statements that received >80% agreement, minor iterative edits were performed until there was unanimous consensus. If a threshold of 80% agreement was not reached, the statement was modified based on feedback and included in the next Delphi round. Statements were rejected if no consensus was reached after 3 rounds. RESULTS: After 3 Delphi rounds, 41 of 42 statements were accepted either in their original version (n = 11) or after modification based on expert input (n = 30). DISCUSSION: Through a modified Delphi process, we developed expert and evidence-based consensus recommendations to guide safe and appropriate use of liquid nitrogen spray cryotherapy in Barrett's esophagus and esophageal cancer.

Introduction: We performed a systematic review and meta-analysis studying the efficacy and safety of cold versus hot endoscopic mucosal resection (EMR) for resection of sessile serrated polyps (SSPs) ≥10 mm. Methods: Multiple databases were searched until January 2023 for studies reporting outcomes of cold versus hot EMR for SSPs ≥10 mm. The primary outcome was the residual SSP rate. Secondary outcomes included technical success rate, R0 resection rate, and adverse events. We used standard meta-analysis methods using the random-effects model, and I 2% was used to assess heterogeneity. Results: Thirteen studies were included in the final analysis. In all, 1896 SSPs were included with a mean polyp size of 23.7 mm (range, 15.9 to 33). A total of 1452 SSPs were followed up for a median follow-up duration of 15.3 months (range, 6 to 37). The pooled residual SSP rate for cold EMR was 4.5% (95% CI: 1.0-17.4), and 5.1% (95% CI: 2.4-10.4) for hot EMR (P=0.9). The pooled rates of technical success, R0 resection, immediate bleeding, and perforation were comparable. Hot EMR was significantly associated with lower piecemeal resection (59.2% vs. 99.3%, P<0.001), higher en-bloc resection (41.4% vs. 1.4%, P<0.001), and delayed bleeding rate (4% vs. 0.7%, P=0.05) compared to cold EMR. Conclusions: Cold EMR has similar efficacy compared to hot EMR for resection of SSP ≥ 10 mm, despite limitations in piecemeal R0 resection rate reporting. Although hot EMR was associated with a higher rate of en-bloc resection, it also showed an increased risk of delayed bleeding compared to cold EMR.

Objective: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). Background: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. Methods: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). Results: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. Conclusions: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.

260 Background: dysphagia (dys) palliation in non-operable esophageal cancer (EC) continues to be a challenge. While chemotherapy and radiation help with dys, many patients require endoscopic interventions during their illness. Self-expanding metal stents have been the mainstay of endoscopic interventions but have a significant risk of severe adverse events and prevent the patient from being able to lie flat without severe reflux. Cryotherapy (cryo) is an emerging technique that can be used while the patient is receiving systemic therapy (ST). Previous retrospective studies showed improvement in dys with a favorable adverse event profile but did not report on quality of life (QOL) or reflux symptoms in patients receiving ST. Prospective studies have shown modest improvement in dys and QOL in patients not receiving ST. This prospective study reports the outcomes of cryo including dys, QOL, reflux symptoms and adverse events (AE) in patients receiving ST. Methods: A prospective multicenter cohort study of 35 adult inoperable EC patients undergoing cryo from Sep 2017 to Aug 2021. QoL was assessed using a modified EORTC QLQ-OES18 questionnaire (score 18 to 72, higher scores indicating worse QoL) while dys was measured using a 4-point Likert scale (0, no Dys; 1, Dys to solids; 2, Dys to semi-solids; 3, Dys to liquids; 4, Dys to saliva) at the start of cyro and 1-2 weeks post cryo. Paired t-test was used to evaluate changes in QoL and Dys between pre- and post-cryo. Results: There were 29 males and 6 females (30 stage IV and 5 stage III at diagnosis). Among 35 patients, a total of 104 cryo procedures were performed, with a mean of 3 per patient. The median number of tumor sites treated per cryo was 2 while the median number of cryo cycles delivered per tumor site was 3. The median total freeze time per tumor site was 60 seconds. The mean QoL score improved significantly from 31.8 pre-cryo to 28.2 with one cryo session (improvement of 3.6 points; p < 0.001). The mean dysphagia score improved significantly from 1.42 to 1.05 per cryo session (improvement of 0.37 points; p = 0.002). The mean After a mean of 3 cryo sessions, QoL score improved significantly from 35.9 pre-cryo to 29.8 post-cryo (improvement of 6 points; p = 0.001) and the mean dysphagia score improved significantly from 1.97 pre-cryo to 1.25 post-cryo (improvement of 0.72 points; p = 0.004). 86.5% of patient were able to sleep lying flat without heartburn or regurgitation. 6 patients received another intervention (1 stenting, 3 radiation and 2 dilation) for Dys palliation. 8 patients underwent feeding tube placement. Cryotherapy related grade 3 or higher adverse events occurred after 3 cryo sessions. Conclusions: Cryotherapy for palliation in non operable esophageal cancer improved dysphagia and quality of life without causing reflux and had a favorable adverse event profile with most patients not needing another intervention for dysphagia palliation.

342 Background: Palliation of dysphagia (Dys) in patients with inoperable esophageal cancer (EC) can be challenging. The major goal of palliation therapy is to improve patient’s quality of life (QoL) and Dys and allow adequate caloric intake. The most commonly used palliative modalities for Dys are radiation therapy (RT) and esophageal stenting. However, RT is limited by total dose and adverse events (AE) in patients receiving systemic therapy (ST), and stenting suffers from a high rate of AE including reflux and chest pain. A relatively new modality of liquid nitrogen endoscopic spray cryotherapy (cryo) has been reported in retrospective studies to improve Dys in patients receiving systemic therapy. We prospectively evaluated Dys and QoL of patients with inoperable EC undergoing cryo in addition to ST for palliation. Methods: A prospective multicenter study of 24 adult inoperable EC patients undergoing cryo and ST for palliation at 4 specialized cancer centers from Sep 2017 to Aug 2019. QoL was assessed using a modified EORTC QLQ-OES18 questionnaire (score 18 to 72, with higher scores indicating worse QoL). Dys was measured using a 4-point Likert scale: 0, no Dys; 1, Dys to solids; 2, Dys to semi-solids; 3, Dys to liquids; 4, Dys to saliva. Paired t-test was used to evaluate change in QoL and Dys between pre- and post-cryo. Results: There were 19 males and 5 females (17 stage IV, 5 stage III, and 2 stage II at diagnosis). Among 24 patients, a total of 71 cryo were performed, with a mean of 2.9 treatments per patient. After a median follow-up of 2 months, the mean EORTC score improved significantly from 35.4 at baseline to 25.5 at last follow-up ( p < 0.001). Similarly, the Dys score improved significantly from 2.0 at baseline to 0.87 at last follow-up ( p < 0.001). Grade 3 or higher AE were seen in only one patient (4%) who had GI bleeding 2 weeks after cryo and was diagnosed with bleeding from severe reflux esophagitis related to gastric outlet obstruction. Conclusions: The analysis of this multicenter prospective study shows that cryo in addition to ST for palliation of EC is well tolerated with significant improvement in Dys and QoL.