이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 8월 2일 업데이트: Hua Meng, China-Japan Friendship Hospital

One-year Clinical Outcomes of Endoscopic Cardia Banding Plication for Refractory Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy: a Single-center Retrospective Cohort Study

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

47

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100029
        • China Japan Friendship Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: endoscopic cardia banding plication
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Gastroesophageal Reflux Disease Questionnaire
기간: 1 year
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 9월 28일

기본 완료 (실제)

2025년 9월 29일

연구 완료 (실제)

2025년 9월 29일

연구 등록 날짜

최초 제출

2026년 7월 23일

QC 기준을 충족하는 최초 제출

2026년 8월 2일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 2일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2021-112-K70-1
  • Elite Medical Professionals Pr (기타 식별자: China Japan Friendship Hospital)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다