Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy

NCT02721862 | Unknown Phase 3 DMC

• 1 other identifier: SUR.RA.01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized double-blind placebo-controlled trial with a total of 100 patients who are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.

Conditions

Cholelithiasis

Keywords

gallstones; cholelithiasis; sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of gallstone formation after laparoscopic sleeve gastrectomy

  Patients in both arms will undergo a total of three abdominal ultrasounds after their bariatric surgery (at 6 months, at 12 months, and at 18 months) to check for gallstones. Once gallstone formation is detected at any of these time points, no additional ultrasounds will be done and the incidence of gallstone formation (Percentage of patients with gallstone formation on ultrasound) will be calculated.

  At 6 months to 18 months after laparoscopic sleeve gastrectomy

Study Arms (2)

Experimental

EXPERIMENTAL

This arm will include 50 patients who, at baseline ultrasound, have no gallbladder pathology and have no previous cholecystectomy. Those patients will be taking an oral drug (Ursodeoxycholic Acid 250mg) twice daily for a period of six months and undergoing a total of three gallbladder ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.

Drug: Ursodeoxycholic Acid; Radiation: Gallbladder Ultrasound

Control

PLACEBO COMPARATOR

This arm will include 50 patients who, at baseline ultrasound, have no gallbladder pathology and have no previous cholecystectomy. Those patients will be taking a placebo, that is dispensed from the pharmacy and having the same color as the ursodeoxycholic acid 250mg, twice daily for a period of six months and undergoing a total of three gallbladder ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.

Drug: Placebo; Radiation: Gallbladder Ultrasound

Interventions

Ursodeoxycholic Acid DRUG

Ursodeoxycholic acid, is FDA approved for the reduction in gallstone formation in obese patients undergoing rapid weight loss.Ursofalk is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder.

Also known as: Ursofalk

Experimental

Placebo DRUG

The placebo has the same color and size as the ursodeoxycholic acid 250 mg pill

Also known as: Sugar pill

Control

Gallbladder Ultrasound RADIATION

Each patient will undergo a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months after sleeve gastrectomy) to check for gallstones. Patients should be gallstone free on an initial ultrasound to satisfy the study inclusion criteria. Ultrasound testing is radiation free and does not pose any additional risk to the subjects.

Control; Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patients (body mass index \> 35 kg/m2) undergoing laparoscopic sleeve gastrectomy as a primary treatment for their obesity.
• No gallstone disease on initial ultrasounds
• No previous cholecystectomy

You may not qualify if:

• Bariatric patients with gallbladder stones on baseline ultrasound examination.
• Patients with a previous cholecystectomy

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Makassed General Hospital: collaborator

Study Sites (2)

American University of Beirut Medical Center

Beirut, 1107 2020, Lebanon

RECRUITING

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Gallstones

Interventions

Ursodeoxycholic Acid; Sugars

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Carbohydrates

Study Officials

• Ramzi S. Alami, Md, FACS

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramzi S. Alami, MD, FACS

CONTACT

+961-1-350000; ra204@aub.edu.lb

Bassem Y. Safadi, MD, FACS

CONTACT

+961-1-350000; bs21@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACS

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 29, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 14, 2017

Record last verified: 2016-03

Locations

LE (2)