Single Anastomosis Versus Standard Duodenal Switch

Overview

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Full Title of Study: “Single Anastomosis Versus Standard Duodenal Switch – a Prospective Randomized Single-blinded Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2023

Detailed Description

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure. Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery. However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins. Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique. The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Interventions

  • Procedure: Standard Duodenal Switch
  • Procedure: Single Anastomosis Duodenal Switch

Arms, Groups and Cohorts

  • Active Comparator: BPD-DS
    • Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb
  • Experimental: SADI
    • Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel

Clinical Trial Outcome Measures

Primary Measures

  • Excess weight loss
    • Time Frame: 2 years
    • Excess weight loss at 2 years of follow-up %EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values
  • Rate of protein deficiency or insufficiency
    • Time Frame: from baseline up to 60 months
    • Rate of protein deficiency (<35gr/l) or insufficiency (<30gr/l)
  • Mortality rate
    • Time Frame: from baseline up to 60 months
    • Rate of mortality
  • BMI
    • Time Frame: 2 years
    • change in BMI at 2 years follow-up as compared to preoperative reference values

Secondary Measures

  • Complication rate
    • Time Frame: from baseline up to 60 months
    • overall and surgery-specific complications
  • Cure rate of comorbidities
    • Time Frame: from baseline up to 60 months
    • Remission rate for comorbidities, including T2D, Hypertension, dyslipidemia, sleep apnea
  • Rate of minerals and vitamin deficiencies
    • Time Frame: from baseline up to 60 months
    • Rate of deficiency and insufficiency in mineral and vitamins
  • Body composition by bioimpedance measures
    • Time Frame: from baseline up to 60 months
    • body fat composition (%) assessed by biompedance
  • Change in quality of life
    • Time Frame: from baseline up to 60 months
    • 36-item short form survey score from 0 to 100
  • Change in quality of life
    • Time Frame: from baseline up to 60 months
    • Bariatric Analysis and Reporting Outcomes System score from -7 to 9
  • Change in quality of life
    • Time Frame: from baseline up to 60 months
    • Laval Questionnaire score from 0 to 7
  • Change in quality of life
    • Time Frame: from baseline up to 60 months
    • GastroIntestinal Quality of Life Index from 0 to 144
  • Change in gatroesophageal reflux symptom
    • Time Frame: from baseline to 60 months
    • GastroEsophageal Reflus Disease Score from 0 to 72

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥18 years and ≤60 years – Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35 – Give written informed consent Exclusion Criteria:

Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:

  • Presence of the following baseline comorbidities: – Inflammatory bowel disease (IBD), – Cirrhosis – History of gastric or duodenal ulcers – Preoperative hypoalbuminemia (<35 g/L) – History of severe renal, hepatic, cardiac or pulmonary disease – Past esophageal, gastric or bariatric surgery – Type 1 Diabetes – Pregnancy – Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations – History of drug use or alcohol abuse in the last 6 months – History of gastro-intestinal inflammatory diseases

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Laval University
  • Collaborator
    • Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laurent Biertho, Principal Investigator – Laval University
  • Overall Official(s)
    • Laurent Biertho, MD, Principal Investigator, Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Overall Contact(s)
    • Suzy Laroche, 418-656-8711, suzy_laroche@ssss.gouv.qc.ca

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