One-year Clinical Outcomes of Endoscopic Cardia Banding Plication for Refractory Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

NCT07749352 | Completed DMC

• 2 other identifiers: 2021-112-K70-1Elite Medical Professionals Pr
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center retrospective cohort study was conducted at the Center for Bariatric and Metabolic Surgery, China-Japan Friendship Hospital, Beijing, China, and is reported in accordance with the STROBE guidelines for observational studies \[18\]. Consecutive eligible patients were enrolled between 28 September 2022 and 29 July 2025; each patient was followed under a standardized 12-month schedule, with the last follow-up visit on 16 July 2026 and data extraction on 17 July 2026. The study protocol was approved by the institutional ethics committee , and the requirement for individual informed consent was waived because of the retrospective design and use of de-identified data. To minimize selection and information bias, consecutive eligible patients were enrolled, all procedures were performed by a single operator, symptoms were assessed with a standardized questionnaire on a fixed follow-up schedule, and data were extracted in de-identified form. All consecutive eligible patients during the study period were included; no a priori sample-size calculation was performed given the exploratory design. There were no missing data for analyzed variables; patients with incomplete baseline or follow-up data were excluded. Consecutive patients who underwent ECBP for refractory GERD after LSG were screened. Eligible patients met the following inclusion criteria: (i) previous LSG for obesity; (ii) refractory GERD, defined as persistent typical reflux symptoms despite standard-dose PPI therapy for at least 8 consecutive weeks; (iii) age ≥18 years; and (iv) completion of a standardized 12-month postoperative follow-up. Exclusion criteria included: (i) hiatal hernia identified on preoperative endoscopy, because band ligation of the cardia is not expected to correct the anatomical defect associated with a hiatal hernia, and such patients are generally referred for alternative management; (ii) previous gastric or anti-reflux surgery other than LSG; (iii) contraindications to endoscopic intervention; and (iv) incomplete baseline or follow-up data. All patients underwent routine preoperative endoscopic evaluation to confirm the absence of hiatal hernia and to characterize the gastroesophageal junction. A total of 47 patients were included (ECBP alone, n = 38; ECBP plus BTX, n = 9); patients who did not complete the 12-month follow-up were excluded, and all 47 included patients completed the standardized 12-month schedule.

Conditions

Gastroesophageal Reflux Disease (GERD)

Outcome Measures

Primary Outcomes (1)

• Gastroesophageal Reflux Disease Questionnaire

  There are six items: heartburn, abdominal pain, reflux, nausea, sleep disturbances, and frequency of additional medication. Each item is scored based on its frequency of occurrence, with 0, 1, 2-3, and ≥4 days in the past week corresponding to scores of 0, 1, 2, and 3, respectively. The total score ranges from 0 to 18, with a higher score indicating more severe symptoms

  1 year

Study Arms (1)

endoscopic cardia banding plication

ACTIVE COMPARATOR

Procedure: endoscopic cardia banding plication

Interventions

endoscopic cardia banding plication PROCEDURE

Endoscopic cardia banding plication (ECBP) narrows the cardiac orifice by band ligation alone, without mucosal resection, and may potentially combine technical simplicity with a favorable safety profile; however, evidence in the post-LSG setting remains scarce. Botulinum toxin (BTX), established for modulating sphincteric tone in achalasia and investigated intragastrically for weight control with conflicting meta-analytic results

endoscopic cardia banding plication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• previous LSG for obesity;
• refractory GERD, defined as persistent typical reflux symptoms despite standard-dose PPI therapy for at least 8 consecutive weeks;
• age ≥18 years; a
• completion of a standardized 12-month postoperative follow-up

You may not qualify if:

• hiatal hernia identified on preoperative endoscopy, because band ligation of the cardia is not expected to correct the anatomical defect associated with a hiatal hernia, and such patients are generally referred for alternative management;
• previous gastric or anti-reflux surgery other than LSG;
• contraindications to endoscopic intervention; - incomplete baseline or follow-up data. All patients underwent routine preoperative endoscopic evaluation to confirm the absence of hiatal hernia and to characterize the gastroesophageal junction

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China Japan friendship hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (6)

• Ness-Jensen E, Lagergren J. Tobacco smoking, alcohol consumption and gastro-oesophageal reflux disease. Best Pract Res Clin Gastroenterol. 2017 Oct;31(5):501-508. doi: 10.1016/j.bpg.2017.09.004. Epub 2017 Sep 7.

  PMID: 29195669 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.

  PMID: 18064739 BACKGROUND

• Sumi K, Inoue H, Kobayashi Y, Iwaya Y, Abad MRA, Fujiyoshi Y, Shimamura Y, Ikeda H, Onimaru M. Endoscopic treatment of proton pump inhibitor-refractory gastroesophageal reflux disease with anti-reflux mucosectomy: Experience of 109 cases. Dig Endosc. 2021 Mar;33(3):347-354. doi: 10.1111/den.13727. Epub 2020 Aug 11.

  PMID: 32415898 BACKGROUND

• Trad KS, Barnes WE, Simoni G, Shughoury AB, Mavrelis PG, Raza M, Heise JA, Turgeon DG, Fox MA. Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial. Surg Innov. 2015 Feb;22(1):26-40. doi: 10.1177/1553350614526788. Epub 2014 Apr 21.

  PMID: 24756976 BACKGROUND

• Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.

  PMID: 25379861 BACKGROUND

• DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.

  PMID: 24500799 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 6, 2026
• Study Start: September 28, 2022
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)