Loop Duodenal Switch Surgery in Morbidly Obese Patients

Stopped early

Conditions studied: Obesity, Type-2 Diabetes Mellitus

In brief

The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS procedure is safer and easier to perform as it only requires one anastomosis compared to the BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic comorbidities, including type-2 diabetes mellitus. However, the initial publications of the loop DS still resulted in a small number of patients with total protein malnutrition. For this reason, the investigators will study the loop DS with a modification of the originally published technique with a longer common channel limb (300 cm) to reduce the risk of protein malnutrition For patients with a BMI \>50, many are limited to just a sleeve gastrectomy as other bariatric procedures are technically challenging with increased operative risk. A loop duodenal switch may be a safer operation with improved weight loss for the super-morbidly obese patient.

Key facts

Study ID

NCT02671331

Run by

Medical College of Wisconsin

People needed

1

Starts

2016-01-01

Expected to finish

2016-07-01

Last updated by the study team

2016-07-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject must be 18-70 years of age at time of enrollment.
• The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
• The subject is under consideration for surgery for obesity or metabolic disease and elects to undergo a primary loop duodenal switch procedure or as a conversion procedure for failed, sustained weight loss after a sleeve gastrectomy or laparoscopic adjustable gastric band performed more than 12 months prior to time of evaluation.
• The subject has a BMI of greater than or equal to 40 kg/m2 at time of surgical consultation.

You may not qualify if…

• Subjects under 18 years of age or older than 70 years of age.
• Subject is not willing or able to participate in the study procedures and understand the informed consent.
• The subject wishes to under a different bariatric procedure other than the loop duodenal switch.
• The subject has a BMI of less than 40 kg/m2 at the time of surgical consultation.
• Any female subject who is pregnant, or is actively breast-feeding
• Any subject who is considered to be part of a vulnerable population (eg. prisoners or those with psychological concerns or those without sufficient mental capacity)
• The procedure is an emergency procedure
• The subject is unable to unwilling to comply with the study requirements or follow-up schedule.
• The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study (eg. severe cardiovascular disease or history of gastrointestinal malignancy, history of upper GI gastric surgery, history of intestinal surgery, open cholecystectomy, immunosuppression, and non-ambulatory).
• The subject has an estimated life expectancy of less than 6 months.
• The subject has participated in an investigational drug or device research study within 30 days of enrollment.
• The subject's insurance company does not cover a duodenal switch operation as treatment for morbid obesity.

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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