Obesity > Single Anastomosis Duodenal Switch

Single vs Standard Duodenal Switch for Obesity

(SADI Trial)

Recruiting in Palo Alto (17 mi)

Overseen By Laurent Biertho, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Laval University

Disqualifiers: IBD, Cirrhosis, Ulcers, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Single Anastomosis Duodenal Switch (SADI-S) for obesity?

Research shows that the Single Anastomosis Duodenal Switch (SADI-S) is effective for weight loss and may have fewer side effects compared to the traditional duodenal switch. It is also considered easier and quicker to perform, making it a promising option for patients who have not achieved sufficient weight loss with other surgeries.

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Is the Single vs Standard Duodenal Switch for Obesity generally safe for humans?

The Single Anastomosis Duodenal Switch (SADI-S) is designed to be safer than the traditional duodenal switch by reducing complications like malnutrition and long surgery times. However, there is a risk of bile reflux, which is a condition where digestive fluid backs up into the stomach and esophagus, potentially causing discomfort.

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How does the Single Anastomosis Duodenal Switch treatment differ from other obesity treatments?

The Single Anastomosis Duodenal Switch (SADI-S) is a simplified version of the traditional duodenal switch surgery, designed to reduce complications like malnutrition and long surgery times while maintaining effective weight loss. It involves a single connection between the intestine and stomach, making it easier and quicker to perform compared to the more complex double-anastomosis approach.

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Eligibility Criteria

This trial is for adults aged 18-60 who meet the criteria for bariatric surgery with a BMI≥35 and can give informed consent. It's not suitable for those with psychological issues affecting treatment compliance, recent substance abuse, gastrointestinal inflammatory diseases, severe organ disease, past stomach surgeries, Type 1 Diabetes or pregnancy.

Inclusion Criteria

People who are 18 years or older and 60 years or younger.

Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35

Give written informed consent

Exclusion Criteria

You have a psychological issue that may make it difficult for you to understand and follow the study instructions.

You have used illegal drugs or consumed alcohol excessively within the past 6 months.

You have a history of inflammatory diseases in your stomach or intestines.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Biliopancreatic diversion with Duodenal Switch (BPD-DS) or the Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for safety, effectiveness, and outcomes such as excess weight loss, protein deficiency, and comorbidity remission

60 months

Long-term follow-up

Extended monitoring for mortality rate, complication rate, and quality of life changes

60 months

Participant Groups

The study compares two weight loss surgeries: Single Anastomosis Duodenal Switch (a simplified technique) versus the Standard Duodenal Switch. The goal is to see which procedure offers better outcomes in terms of weight loss and diabetes remission while assessing long-term nutritional effects.

Group I: SADI Experimental Treatment 1 Intervention

Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel

Group II: BPD-DS Active Control 1 Intervention

Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb

Single Anastomosis Duodenal Switch is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as SADI-S for:

• Obesity
• Type 2 Diabetes Mellitus

🇪🇺 Approved in European Union as SADI-S for:

• Obesity
• Type 2 Diabetes Mellitus

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Institut Universitaire de Cardiologie et de Pneumologie de Québec Quebec City, Canada

Who Is Running the Clinical Trial?

Laval University Lead Sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Collaborator

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

The single anastomosis duodenal switch modifications: a review of the current literature on outcomes. [2018] The single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) was designed in 2007 to reduce the side effects of biliopancreatic diversion with duodenal switch (BPD-DS) by replacing the Roux-en-Y construction with a single duodeno-ileal anastomosis and combining the common channel with the alimentary limb. Several variants using different channel lengths were published. The objective of this study was to identify the published cases of SADI-S and variants and assess the results regarding potential benefits on side effects and revisions.

2. United States pubmed.ncbi.nlm.nih.gov

Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S): short-term outcomes from a prospective cohort study. [2021] Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the classic duodenal switch (DS). These modifications are intended to address concerns about DS, including malnutrition, longer operative times, and technical challenges, while preserving the benefits.

3. United States pubmed.ncbi.nlm.nih.gov

Single Anastomosis Duodeno-Ileal Switch (SADIS): A Systematic Review of Efficacy and Safety. [2018] Owing to the possibility of weight regain after the long-term follow-up of gastric bypass patients and because of the high morbidity of biliopancreatic diversion with duodenal switch, single-anastomosis duodeno-ileal switch (SADIS) has emerged as a rescue procedure in bariatric surgery.

4. United States pubmed.ncbi.nlm.nih.gov

Single-anastomosis duodenoileal bypass as a second step after sleeve gastrectomy. [2015] After sleeve gastrectomy, many surgical options are available in patients with insufficient weight loss. Duodenal switch is typically considered the operation that results in higher weight loss, although it is, perhaps unjustly, considered technically difficult and may be accompanied by severe side effects. Single-anastomosis duodenoileal bypass with sleeve gastrectomy is a simplification of the duodenal switch that may behave as a standard biliopancreatic diversion but is easier and quicker to perform. Given its effectiveness as a primary surgery we hypothesized that it would be successful as a second-step operation. The objective of this study was to analyze the weight loss and co-morbidities resolution after a single-anastomosis duodenoileal bypass (SADI) performed as a second step after sleeve gastrectomy.

5. United States pubmed.ncbi.nlm.nih.gov

Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. [2022] Describe and analyze the safety and weight loss performance of biliopancreatic diversion and duodenal switch (BPD-DS) and single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), verifying any possible superiority according to preoperative BMI.

6. Spain pubmed.ncbi.nlm.nih.gov

Direct and two-step single anastomosis duodenal switch (SADI-S): Unicentric comparative analysis of 232 cases. [2021] The "Single Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy" (SADI-S) is a bariatric surgery conceived to simplify the duodenal switch in order to reduce its postoperative complications. The objective of this study is to assess the safety and efficacy of SADI-S, comparing its results in both direct and two-step procedure.

7. United States pubmed.ncbi.nlm.nih.gov

Bile Reflux After Single Anastomosis Duodenal-Ileal Bypass with Sleeve (SADI-S): a Meta-analysis of 2,029 Patients. [2022] Single anastomosis duodenal-ileal bypass with sleeve (SADI-S) is a novel bariatric surgery modified from the classic biliopancreatic diversion with duodenal switch (BPD-DS). These surgical modifications address most BPD-DS hurdles, but the risk of bile reflux may hinder SADI-S acceptance. We aimed to evaluate the event rate of bile reflux after SADI-S.