Functional Changes in the Stomach and Esophagus After One-Anastomosis Gastric Bypass - OAGB - BiFlux Trial
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Spital Limmattal
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Urs Zingg
+41447332126
urs.zingg@clutterspital-limmattal.chSpital Limmattal
(BASEC)
Informazioni generali
+41 44 733 21 26;+41 44 733 21 26
urs.zingg@clutterspital-limmattal.ch(ICTRP)
Informazioni scientifiche
+41 44 733 21 26;+41 44 733 21 26
urs.zingg@clutterspital-limmattal.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
20.05.2020
(BASEC)
ID di studio ICTRP
NCT04422405 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Functional Changes in the Stomach and Esophagus after One Anastomosis Gastric Bypass- OAGB-BiFlux Trial (BASEC)
Titolo accademico
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial (ICTRP)
Titolo pubblico
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB (ICTRP)
Malattie studiate
Obesity, MorbidGERDUlcer, Gastric (ICTRP)
Intervento studiato
Procedure: One Anastomosis Gastric Bypass (OAGB) (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Urs Zingg, MD, Prof.;Urs Zingg, Prof., urs.zingg@spital-limmattal.ch, +41 44 733 21 26;+41 44 733 21 26 (ICTRP)
ID secondari
SLS-003 (ICTRP)
Risultati-Dati individuali dei partecipanti
No (ICTRP)
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04422405 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile