Functional Changes in the Stomach and Esophagus After One-Anastomosis Gastric Bypass - OAGB - BiFlux Trial
Zusammenfassung der Studie
The OAGB is a variant of gastric bypass with a very long, slender gastric pouch, which is only connected to the small intestine by one anastomosis, 150 – 200 cm from Treitz. The anastomosis between the alimentary and biliopancreatic limbs is thus omitted. This simplifies the procedure and creates a malabsorptive variant of the proximal gastric bypass. Numerous obesity surgery societies, including the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), the German (S3 guidelines), or the British, have recognized the OAGB as a standard procedure, but not the SMOB in Switzerland. Potential long-term risks due to malnutrition and bile reflux into the stomach should also be noted. The feared bile reflux into the esophagus has only been described in animal models so far. Long-term consequences of bile reflux into the stomach are so far considered a potential Achilles' heel of the OAGB. After 21 years since the first description of the procedure, however, no case of carcinoma in the stomach or esophagus after OAGB has been described in the literature. To better understand the long-term results of the procedure, these should be recorded in registries over time. One reason for the skepticism towards the OAGB may be that the first series had long follow-up times but very low follow-up rates, making statements about safety unreliable. The most common postoperative problems are anastomotic ulcers with 0.8 to 18%. The present study aims to investigate the risk of postoperative reflux and the resulting mucosal changes in the area of the stomach and esophagus over the long term.
(BASEC)
Untersuchte Intervention
The aim of the study is the prospective evaluation of the influence of the One-Anastomosis Gastric Bypass (OAGB) on the occurrence of postoperative changes in the upper gastrointestinal tract, such as mucosal changes in the stomach and esophagus as well as reflux (acid and biliary). The evaluation will be conducted through preoperative and 2- and 5-year follow-up gastroscopies with biopsies of the stomach and esophagus, as well as through impedance-pH-metry and high-resolution manometry. Additionally, the influence of the OAGB on the postoperative gastrointestinal and reflux-related quality of life of patients after 2 and 5 years will be assessed using standardized questionnaires (GIQLI, GERDQ, GERD-HRQL, BAROS (Bariatric Analysis and Reporting Outcome System) / Moorehead-Ardelt).
(BASEC)
Untersuchte Krankheit(en)
According to WHO (World Health Organization), obesity is present when body weight exceeds a BMI (Body Mass Index) of 30 (body mass (in kilograms) divided by height (in meters) squared). Surgical treatment measures for weight reduction (bariatric surgery) prove to be superior to conservative therapy alone starting from a BMI over 35. Among the surgical procedures that may be performed according to the Swiss Morbid Obesity Group (SMOB) in bariatric surgical reference centers are bariatric basic procedures and complex bariatric procedures. Basic procedures are: • Vertical gastroplasty • Gastric band • Sleeve gastrectomy • Proximal gastric bypass (alimentary limb 150 cm) Complex bariatric procedures are: • Biliopancreatic diversion surgeries (with and without duodenal switch) • Two-stage approach (sleeve gastrectomy followed by duodenal switch or gastric bypass) • Revision surgeries (change of procedure) • Revision surgeries after anti-reflux surgery • Other revision surgeries In addition to the established procedures mentioned above, there are further procedures that are under evaluation and may only be performed in Switzerland according to the SMOB guidelines in prospective studies accepted by the local ethics committee. One of these procedures under evaluation is the laparoscopic One Anastomosis Gastric Bypass (OAGB).
(BASEC)
•BMI over 35 •Age over 18 •Patient signs the informed consent after being informed about the study (BASEC)
Ausschlusskriterien
• Lack of adequate two-year treatment for weight reduction • Comorbidities such as malignant disease, liver cirrhosis, Crohn's disease, serious mental illness not attributable to obesity that has led to more than one hospitalization in a psychiatric institution in the last two years • Preoperative evidence of reflux by endoscopy or impedance-pH-metry, evidence of consequences of reflux disease such as Barrett's esophagus and peptic stricture, as well as evidence of predisposing factors for reflux such as hiatal hernia larger than 4 cm or insufficiency of the lower esophageal sphincter according to manometry (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Spital Limmattal
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Urs Zingg
+41447332126
urs.zingg@clutterspital-limmattal.chSpital Limmattal
(BASEC)
Wissenschaftliche Auskünfte
+41 44 733 21 26;+41 44 733 21 26
urs.zingg@clutterspital-limmattal.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.05.2020
(BASEC)
ICTRP Studien-ID
NCT04422405 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Functional Changes in the Stomach and Esophagus after One Anastomosis Gastric Bypass- OAGB-BiFlux Trial (BASEC)
Wissenschaftlicher Titel
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial (ICTRP)
Öffentlicher Titel
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB (ICTRP)
Untersuchte Krankheit(en)
Obesity, MorbidGERDUlcer, Gastric (ICTRP)
Untersuchte Intervention
Procedure: One Anastomosis Gastric Bypass (OAGB) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- BMI> 35 kg/m2
- 2 years of controlled conservative obesity treatment without weight reduction
- patients should give their consent to participate in the study
Exclusion Criteria:
- Less than 2 years of conservative obesity treatment
- cancer
- cirrhosis Child-Pough score A
- Crohn's disease
- serious psychiatric disorder, which led to in-hospital treatment in psychiatric
clinic in the past two years
- drug consumption
- non-compliance
- hiatal hernia > 4cm
- gastric pouch < 10cm
- Barett esophagus
- erosive esophagitis Grade C or D according to the Los Angeles Classification
- endoscopically proven gastric stricture
- acid exposition time > 6% (Lyon criteria)
- reflux episodes> 80 /24 hours (Lyon criteria)
- insufficient low esophageal sphincter according to manometry findings
- pathological findings in the impedance pH-metry (acid and non-acid reflux) (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Marginal ulcer rates;Marginal ulcer rates;Assessment of age as risk factor for marginal ulcer development;Assessment of age as risk factor for marginal ulcer development;Assessment of gender as risk factor for marginal ulcer development;Assessment of gender as risk factor for marginal ulcer development;Assessment of tobacco use as risk factor for marginal ulcer development;Assessment of tobacco use as risk factor for marginal ulcer development;Assessment of alcohol use as risk factor for marginal ulcer development;Assessment of alcohol use as risk factor for marginal ulcer development;Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development;Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development;Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development;Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development;Assessment of Helicobacter pylori as risk factor for marginal ulcer development;Assessment of Helicobacter pylori as risk factor for marginal ulcer development;Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development;Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development;Assessment of diabetes mellitus as risk factor for marginal ulcer development;Assessment of diabetes mellitus as risk factor for marginal ulcer development;Assessment of dyslipidemia as risk factor for marginal ulcer development;Assessment of dyslipidemia as risk factor for marginal ulcer development;Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development;Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development (ICTRP)
Total weight loss % (TWL);Total weight loss % (TWL);Excess weight loss % (EWL);Excess weight loss % (EWL);Total BMI loss (TBL);Total BMI loss (TBL);Excess BMI loss (EBL);Excess BMI loss (EBL);Late morbidity (>30 days);Late morbidity (>30 days);Incidence of gastroesopagheal reflux disease (GERD);Incidence of gastroesopagheal reflux disease (GERD);Incidence of Barrett's esophagus;Incidence of Barrett's esophagus;Changes of esophageal motor function;Changes of esophageal motor function;Esophageal acid or bolus exposure;Esophageal acid or bolus exposure;Number of acid or alcaline reflux events;Number of acid or alcaline reflux events;Gastrointestinal quality of life (QoL): GIQLI;Gastrointestinal quality of life (QoL): GIQLI;Obesity- related quality of life (QoL): BAROS;Obesity- related quality of life: BAROS;Reflux-associated symptoms;Reflux-associated symptoms;Reflux-associated quality of life (QoL): GERD-HRQL;Reflux-associated quality of life (QoL): GERD-HRQL (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Urs Zingg, MD, Prof.;Urs Zingg, Prof., urs.zingg@spital-limmattal.ch, +41 44 733 21 26;+41 44 733 21 26 (ICTRP)
Sekundäre IDs
SLS-003 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No (ICTRP)
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04422405 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar