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

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ClinicalTrials.gov Identifier: NCT02721862
Recruitment Status : Unknown
Verified March 2016 by Dr. Ramzi Alami, American University of Beirut Medical Center.
Recruitment status was:  Recruiting
First Posted : March 29, 2016
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Makassed General Hospital
Information provided by (Responsible Party):
Dr. Ramzi Alami, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Drug: Ursodeoxycholic Acid Drug: Placebo Radiation: Gallbladder Ultrasound Phase 3

Detailed Description:

A significant proportion of patients are known to develop gallstones during the phase of rapid weight loss after bariatric surgery. A small percentage of these patients develop symptoms such as abdominal pain, nausea, vomiting, and occasionally more serious symptoms relating to gallbladder disease. Those patients may require surgery for the removal of their gallbladder even though the risks of gallbladder surgery are increased in this patient group.

The investigators would like to provide patients who have undergone Laparoscopic Sleeve Gastrectomy a drug that will reduce the risk of developing gallstones during the phase of rapid weight loss after surgery. The drug, Ursodeoxycholic acid, is FDA approved for the reduction in gallstone formation in obese patients undergoing rapid weight loss but has never been proven effective, by randomized controlled studies, in the subgroup of obese patients undergoing Laparoscopic Sleeve Gastrectomy. If proven so, the investigators intend to influence the current practice such that all patients are offered Ursodeoxycholic Acid for the reduction of gallstone formation and their complications following Laparoscopic Sleeve Gastrectomy.

In this randomized double-blind placebo-controlled trial, the subjects will be approached by the principal investigator in the clinic with information about taking part in this study, after the decision is made to undergo Laparoscopic Sleeve Gastrectomy for weight loss. The surgeon will answer any questions then and thereafter. The investigators will clarify that participation is voluntary and will not alter routine care whether the patient participates or not. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) 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. 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.

A total of 100 patients need to be recruited. The sample is comparable to current studies and is sufficient to prove or disprove the hypothesis with low risk of error (ref). The patients will either receive placebo or the drug under study, the placebo being dispensed from the pharmacy and having the same color as the ursodeoxycholic acid. The principal investigator and the radiologists measuring the result will be blinded to whether the subject receives the drug or placebo.

The study needs to involve human subjects so that the results will be applicable to human subjects. The risk is small because the drug is FDA approved with 13 years post-marketing experience for related indications and is known to be well tolerated. All efforts will be made to protect the privacy and confidentiality of the subjects including protecting their personal information by removing identifiers from data records and storing the identifying codes in a separate location, with all study material under password protection or lock and key at all times.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy: A Prospective Randomized Multicenter Placebo-Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
Drug Information available for: Ursodiol

Arm Intervention/treatment
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
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.
Other Name: Ursofalk

Radiation: Gallbladder Ultrasound
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.

Placebo Comparator: Control
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
The placebo has the same color and size as the ursodeoxycholic acid 250 mg pill
Other Name: Sugar pill

Radiation: Gallbladder Ultrasound
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.




Primary Outcome Measures :
  1. Incidence of gallstone formation after laparoscopic sleeve gastrectomy [ Time Frame: At 6 months to 18 months 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721862


Contacts
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Contact: Ramzi S. Alami, MD, FACS +961-1-350000 ext 5238 ra204@aub.edu.lb
Contact: Bassem Y. Safadi, MD, FACS +961-1-350000 ext 5811 bs21@aub.edu.lb

Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon, 1107 2020
Contact: Ramzi S. Alami, MD, FACS    +961-1-350000 ext 5238    ra204@aub.edu.lb   
Makassed General Hospital Recruiting
Beirut, Lebanon
Contact: Hayssam Fawal, MD, FACS    +961-3-824228    hayssamfawal@gmail.com   
Sponsors and Collaborators
American University of Beirut Medical Center
Makassed General Hospital
Investigators
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Principal Investigator: Ramzi S. Alami, Md, FACS American University of Beirut Medical Center

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Responsible Party: Dr. Ramzi Alami, MD, FACS, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02721862     History of Changes
Other Study ID Numbers: SUR.RA.01
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Ramzi Alami, American University of Beirut Medical Center:
gallstones
cholelithiasis
sleeve gastrectomy

Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents