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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Zhejiang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
TingBo Liang, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01459549
First received: October 21, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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 Intervention
Hepatolithiasis
Sphincter of Oddi Laxity
Procedure: Roux-en-Y choledochojejunostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Treating Hepatolithiasis(Accompanied With Sphincter of Oddi Laxity) With Roux-en-Y Choledochojejunostomy

Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • recurrence rate of hepatolithiasis [ Time Frame: within five years after the operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: hepatolithiasis, non-choledochojejunostomy Procedure: Roux-en-Y choledochojejunostomy
Roux-en-Y choledochojejunostomy must be operated

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.

  Eligibility

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459549

Contacts
Contact: Liang TingBo, MD,PHD 086-571-87236688 liangtingbo@zju.edu.cn

Locations
China, Zhejiang
the First Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Liang TingBo, MD, PHD    086-571-87236688    liangtingbo@zju.edu.cn   
Sponsors and Collaborators
TingBo Liang
  More Information

No publications provided

Responsible Party: TingBo Liang, Zhejiang University
ClinicalTrials.gov Identifier: NCT01459549     History of Changes
Other Study ID Numbers: ZYYYSOL
Study First Received: October 21, 2011
Last Updated: October 24, 2011
Health Authority: China: Ethics Committee

Keywords provided by Zhejiang University:
hepatolithiasis
sphincter of oddi laxity
choledochojejunostomy

ClinicalTrials.gov processed this record on October 21, 2014