Randomized Controlled Trial of Treating Hepatolithiasis (Accompanied With SOL) With Choledochojejunostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01459549
Recruitment Status : Recruiting
First Posted : October 25, 2011
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):
TingBo Liang, Zhejiang University

Brief Summary:
The purpose of this study is to determine whether Roux-en-Y choledochojejunostomy is a more effective treatment for the hepatolithiasis patients accompanied with Sphincter of Oddi Loose.

Condition or disease Intervention/treatment Phase
Hepatolithiasis Sphincter of Oddi Laxity Procedure: Roux-en-Y choledochojejunostomy Not Applicable

Detailed Description:
Hepatolithiasis (HL) is prevalent in East Asia, especially in China. While this condition results from multiple etiological factors, obstructive cholangitis is usually the main cause. In our clinical experience, the investigators have found few cases with obstruction of the common bile duct or sphincter of Oddi; to the contrary, almost half of our clinical cases showed sphincter of Oddi laxity (SOL). SOL results in reflux of duodenal fluid and Escherichia coli (E. coli) infection, which lead to the formation of stones in the biliary tract. Thus, HL tends to recur in SOL patients. For these patients, Roux-en-Y choledochojejunostomy(choledochojejunostomy with an anti-reflux ansa intestinalis) may be the most promising therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Treating Hepatolithiasis(Accompanied With Sphincter of Oddi Laxity) With Roux-en-Y Choledochojejunostomy
Study Start Date : October 2011
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
No Intervention: Control Group
Just clear the stone without choledochojejunostomy
Experimental: Experimental Group
Clear the stone combined with Roux-en-y choledochojejunostomy
Procedure: Roux-en-Y choledochojejunostomy
Roux-en-Y choledochojejunostomy must be operated

Primary Outcome Measures :
  1. recurrence rate of hepatolithiasis [ Time Frame: within five years after the operation ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosed as hepatolithiasis
  • sphincter of oddi laxity is diagnosed during operation
  • sign the informed consent form voluntary
  • can cooperate well with the followup
  • anticipated to be tolerant of Roux-en-Y choledochojejunostomy

Exclusion Criteria:

  • already underwent choledochojejunostomy at past, which make the function of Sphincter of Oddi unable to be evaluated
  • a lot of stones remain in biliary tract after operation, which make the recurrence or progression of hepatolithiasis unable to be evaluated

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 identifier (NCT number): NCT01459549

Contact: Liang TingBo, MD,PHD 086-571-87236688

China, Zhejiang
the First Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Liang TingBo, MD, PHD    086-571-87236688   
Sponsors and Collaborators
TingBo Liang

Responsible Party: TingBo Liang, Zhejiang University Identifier: NCT01459549     History of Changes
Other Study ID Numbers: ZYYYSOL
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by TingBo Liang, Zhejiang University:
sphincter of oddi laxity