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

2. august 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

47

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gastroesophageal Reflux Disease Questionnaire
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. september 2022

Primær fullføring (Faktiske)

29. september 2025

Studiet fullført (Faktiske)

29. september 2025

Datoer for studieregistrering

Først innsendt

23. juli 2026

Først innsendt som oppfylte QC-kriteriene

2. august 2026

Først lagt ut (Faktiske)

6. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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