SADI-S vs. BPD-DS Surgery for Obesity

Overseen By Amin Andalib, MD MSc FRCSC

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Congestive heart failure, Chronic kidney disease, Inflammatory bowel disease, Pulmonary hypertension, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of surgeries, SADI-S and BPD-DS, to determine which is more effective and safer for individuals with severe obesity. Both surgeries aid weight loss and can improve conditions like type-2 diabetes by altering the interaction between the stomach and intestines. The trial focuses on whether SADI-S, a newer version, offers a better option with fewer side effects. Candidates for the trial include those with severe obesity who have received a surgical recommendation from a doctor. As an unphased trial, this study allows patients to contribute to important research that could enhance surgical options for severe obesity.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the SADI-S procedure is generally safe, with outcomes similar to traditional BPD-DS surgery. Patients undergoing SADI-S often experience weight loss and improvements in obesity-related health issues, such as diabetes. Its safety profile is comparable to other surgeries, like the Roux-en-Y gastric bypass.

While BPD-DS is highly effective for weight loss and diabetes management, it carries a higher risk of nutritional problems, including vitamin deficiencies and inadequate protein intake. One study found that more than half of the patients experienced nutritional issues after BPD-DS, compared to fewer patients after SADI-S.

Overall, SADI-S appears to be gentler on the body with fewer nutritional side effects. However, both surgeries involve risks, and discussing these with a healthcare provider is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for obesity because they offer innovative approaches to weight loss surgery. SADI-S surgery simplifies the traditional BPD-DS procedure by creating a longer common channel, potentially reducing nutrient malabsorption while still offering significant weight loss. This means SADI-S might deliver similar benefits as BPD-DS but with fewer complications related to nutrient deficiencies. On the other hand, BPD-DS remains a powerful procedure by creating a shorter common channel, maximizing weight loss and metabolic improvements but with a complex Roux-en-Y construct. Both techniques aim to refine and optimize outcomes for individuals struggling with obesity beyond what standard sleeve gastrectomies can achieve.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare the SADI-S and BPD-DS procedures for obesity. Research has shown that the SADI-S procedure, which participants in this trial may receive, is highly effective for weight loss and improving obesity-related health issues, such as type-2 diabetes. Studies indicate that patients undergoing SADI-S experience significant weight loss and a 60.1% rate of diabetes improvement within two years. Its safety is comparable to other common procedures like RYGB.

In contrast, the BPD-DS procedure, another treatment option in this trial, has long been regarded as one of the most effective surgeries for weight loss. It surpasses other methods, with patients losing 67.4% of their excess weight over three years. However, BPD-DS can lead to more nutritional issues, affecting over half of the patients. Both treatments are promising, but they offer different benefits and risks. ^{2 3 4 6 7}

Who Is on the Research Team?

Amin Andalib, MD MSc FRCSC

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who meet the criteria for bariatric surgery. They must be able to give informed consent. It's not suitable for those with poor support/compliance, heart failure, advanced kidney disease, inflammatory bowel disease, pulmonary hypertension, cirrhosis or severe GERD.

Inclusion Criteria

I meet the NIH criteria for weight-loss surgery.

Participants must meet ALL of the following inclusion criteria:

Give written informed consent

Exclusion Criteria

Individuals who were found by any member of the multidisciplinary team (nutritionist, nurse, psychologist, and surgeon) to be at risk for lack of support and poor compliance (e.g. ≥2 missed appointments without a valid justification)

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

I have CHF, CKD stage 3-5, IBD, PHTN, cirrhosis, or severe GERD possibly with Barrett's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Short-term Safety Assessment

Participants undergo the SADI-S or BPD-DS procedure and are monitored for short-term safety, including operative parameters and 30-day postoperative adverse events.

4 weeks

Follow-up

Participants are monitored for weight loss, resolution of type-2 diabetes, quality of life, and long-term morbidities at 1, 6, 12 months and yearly thereafter.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• BPD-DS
• SADI-S

Trial Overview The study compares two weight loss surgeries in obese patients: BPD-DS and a newer version called SADI-S. The goal is to see if SADI-S is as safe and effective as BPD-DS in the short and long term.

How Is the Trial Designed?

Group I: SADI-S Experimental Treatment 1 Intervention

SADI-S involves creating a sleeve gastrectomy but simplifies the bypass part of the BPD-DS by a single anastomosis of a loop of jejunum at 250cm from the ileocecal valve (longer common channel) to the transected first-stage of the duodenum instead of the Roux-en-Y construct.

Group II: BPD-DS Active Control 1 Intervention

BPD-DS involves creating a sleeve gastrectomy and creation of a Roux-en-Y bypass involving a Roux limb (150cm) which is anastomosed to the transected first-stage of the duodenum and a short common channel (100cm).

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40962919/

Long-term 10-year outcomes of biliopancreatic diversion ... More nutritional complications were seen after BPD/DS (53.5% vs 15.6% in SADI-S, p < 0.001). Rates of early and late complications were ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728924009109

Biliopancreatic diversion with duodenal switch results in ... Excess weight loss at 3 years was 40.1% for SG, 54.1% for RYGB, and 67.4% for BPD/DS, with BPD/DS performing significantly better (P < .001). Complete diabetes ...

3. asmbs.org asmbs.org/condition_procedures/biliopancreatic-diversion-with-duodenal-switch/

Biliopancreatic Diversion with Duodenal Switch Among the best results for improving obesity · Affects bowel hormones to cause less hunger and more fullness after eating · It is the most effective procedure for ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819400

Ten-Year Outcomes Following Roux-en-Y Gastric Bypass ... Findings In this randomized clinical trial of 60 participants, the reductions in body weight and BMI were greater after duodenal switch.

5. mayoclinic.org mayoclinic.org/tests-procedures/biliopancreatic-diversion-with-duodenal-switch/about/pac-20385180

Biliopancreatic diversion with duodenal switch (BPD/DS) Learn about a two-part weight-loss procedure that involves making the stomach smaller and reconnecting parts of the small intestine.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728922007237

Long-term outcome after biliopancreatic diversion with ... A total of 116 patients (83.6% female) underwent BPD/DS with a mean initial body mass index (BMI) of 47 ± 6.5 kg/m2. Of these, 68% of the procedures were ...

7. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/bpdds-weightloss-surgery

BPD/DS Weight-Loss Surgery You can lose more weight with the duodenal switch than with the gastric bypass or the sleeve gastrectomy. You'll be at higher risk of developing nutritional ...