Sphincter of Oddi LaxityBDNCT04218669
The Approach of Biliary Drainage in Hepatolithiasis Patients With Sphincter of Oddi Laxity
A study testing Roux-en-Y Hepaticojejunostomy and T-tube drainage in people with Sphincter of Oddi Laxity, run by xpgeng.
Trial summary
Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sphincter of Oddi Laxity
- What is being tested?
- Roux-en-Y Hepaticojejunostomy and T-tube drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age age between 18 and 70 years
- Diagnosed as hepatolithiasis with sphincter of oddi laxity during operation
- Achieved removing the focus, extraction of stones and correction of stricture during the operation
- Written Informed consent
- Willingness for complete 3-year follow-up.
Who cannot join
- Participation in concurrent intervention trials with interference of outcome of this study
- Associated tumor
- Diagnosed as sphincter of oddi complete loss of function or normal
- Underwent choledochojejunostomy at past
- Lack of compliance
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity
Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.
Read the detailed description
Background: SOL results in reflux of duodenal fluid and enteric bacteria infection, which lead to the formation of stones in the biliary tract. Roux-en-Y hepaticojejunostomy (HJ) shows considerable advantage for prevention of reflux of intestinal content into the bile duct. As a result, A randomized controlled trial (RCT) evaluate the therapeutic safety, and perioperative and long-term outcomes of HJ versus T tube drainage for hepatolithiasis with SOL.
Intervention: In total, 210 patients who met the following eligibly criteria were included and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.
Clinical data include: the incidence of biliary complications (stone recurrence; biliary stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic injury; quality of life.
- Conditions
- Sphincter of Oddi Laxity
- Being tested
- Roux-en-Y Hepaticojejunostomy, T-tube drainage
- Keywords
- sphincter of Oddi laxity, hepatolithiasis, choledochojejunostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y HepaticojejunostomyProcedure or surgery
The common hepatic duct was cut and the duodenal side is closed by suture. The small intestine was cut off 15 cm below the ligament of Treitz. The distal end was lifted, and a 1-2 cm incision was made at the jejunal wall 4-5 cm from the jejunal stump. The anastomosis is used a 5-0 PSD Ⅱ suture, with double needles, inside-out in the jejunum and outside-in in the hepatic duct. One side of needles was used to continuely penetrate and suture the whole layer of the posterior-lateral wall of the jejunum, the posterior-lateral wall of the biliary duct, and the other side of needles was used to continuely stuere the anterior part of the anastomosis. Mucosa-to-mucosa contact should be ensured with every stitch.The anastomotic stomas were then checked for leakage. Enteric-enteric anastomosis was performed 60 cm below the site of the hepatojejunal anastomosis.
T-tube drainageProcedure or surgery
The T-tube was placed for biliary drainage and the common bile duct was intermittently sutured with 4-0 vicryl sutures.
| Study group | Role | What they receive |
|---|---|---|
| T-tube drainage | Active comparator | The T-tube was placed for biliary drainage Receives: Procedure: T-tube drainage |
| Roux-en-Y Hepaticojejunostomy | Experimental | biliary-enteric anastomosis was performed Receives: Procedure: Roux-en-Y Hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone recurrence rate
A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)
Measured: 3 years
biliary stricturer rate
Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)
Measured: 3 years
Cholangitis rate
The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)
Measured: 3 years
Secondary outcomes (5)
sphincter of oddi function
Grading criteria for the SO function were as follows: Normal; Laxity and Loss of function
Measured: an expected average of 120 minutes
Mortality
Operative mortality was defined as any death resulting from a complication during surgery
Measured: 90 days
Biliary leakage
Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
Measured: 90 days
total bilirubin
serum total bilirubin on 3 postoperative day (umol/L)
Measured: 90 days
quality of life grading
Quality of life will be assessed by Visick score (Ⅰ～Ⅳ).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sphincter of Oddi LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized to choledochojejunostomy arm or T tube drainage arm
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xpgeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xpgeng, The Second Hospital of Anhui Medical University
- Investigators
- Bao Fu Liu, PhD, Study chair, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218669
- Sponsor's protocol ID
- 1804h08020239
- Acronym
- BD
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen JM, Yan XY, Zhu T, Chen ZX, Zhao YJ, Xie K, Liu FB, Geng XP. T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial. Trials. 2020 Jun 29;21(1):586. doi: 10.1186/s13063-020-04483-z.
PubMed 32600474
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity
- ClinicalTrials.gov ID
- NCT04218669
- Acronym / sponsor ID
- BD / 1804h08020239
- Conditions
- Sphincter of Oddi Laxity
- Keywords
- sphincter of Oddi laxity, hepatolithiasis, choledochojejunostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- xpgengUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.
Detailed description
Background: SOL results in reflux of duodenal fluid and enteric bacteria infection, which lead to the formation of stones in the biliary tract. Roux-en-Y hepaticojejunostomy (HJ) shows considerable advantage for prevention of reflux of intestinal content into the bile duct. As a result, A randomized controlled trial (RCT) evaluate the therapeutic safety, and perioperative and long-term outcomes of HJ versus T tube drainage for hepatolithiasis with SOL.
Intervention: In total, 210 patients who met the following eligibly criteria were included and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.
Clinical data include: the incidence of biliary complications (stone recurrence; biliary stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic injury; quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomized to choledochojejunostomy arm or T tube drainage arm
| Arm | Type | Receives |
|---|---|---|
| T-tube drainage | Active comparator | Procedure: T-tube drainageThe T-tube was placed for biliary drainage |
| Roux-en-Y Hepaticojejunostomy | Experimental | Procedure: Roux-en-Y Hepaticojejunostomybiliary-enteric anastomosis was performed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age age between 18 and 70 years
- Diagnosed as hepatolithiasis with sphincter of oddi laxity during operation
- Achieved removing the focus, extraction of stones and correction of stricture during the operation
- Written Informed consent
- Willingness for complete 3-year follow-up.
Key exclusion criteria (5 listed)
- Participation in concurrent intervention trials with interference of outcome of this study
- Associated tumor
- Diagnosed as sphincter of oddi complete loss of function or normal
- Underwent choledochojejunostomy at past
- Lack of compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y HepaticojejunostomyThe common hepatic duct was cut and the duodenal side is closed by suture. The small intestine was cut off 15 cm below the ligament of Treitz. The distal end was lifted, and a 1-2 cm incision was made at the jejunal wall 4-5 cm from the jejunal stump. The anastomosis is used a 5-0 PSD Ⅱ suture, with double needles, inside-out in the jejunum and outside-in in the hepatic duct. One side of needles was used to continuely penetrate and suture the whole layer of the posterior-lateral wall of the jejunum, the posterior-lateral wall of the biliary duct, and the other side of needles was used to continuely stuere the anterior part of the anastomosis. Mucosa-to-mucosa contact should be ensured with every stitch.The anastomotic stomas were then checked for leakage. Enteric-enteric anastomosis was performed 60 cm below the site of the hepatojejunal anastomosis. | Procedure or surgery | Roux-en-Y Hepaticojejunostomy |
| T-tube drainageThe T-tube was placed for biliary drainage and the common bile duct was intermittently sutured with 4-0 vicryl sutures. | Procedure or surgery | T-tube drainage |
Primary outcome
stone recurrence rate
Time frame: 3 years
A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)
biliary stricturer rate
Time frame: 3 years
Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)
Cholangitis rate
Time frame: 3 years
The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)
5 secondary outcomes
sphincter of oddi function
Time frame: an expected average of 120 minutes
Mortality
Time frame: 90 days
Biliary leakage
Time frame: 90 days
total bilirubin
Time frame: 90 days
quality of life grading
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Derived from this study: PubMed 32600474Chen JM, Yan XY, Zhu T, Chen ZX, Zhao YJ, Xie K, Liu FB, Geng XP. T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial. Trials. 2020 Jun 29;21(1):586. doi: 10.1186/s13063-020-04483-z.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bao Fu Liu, PhD study chair
The First Affiliated Hospital of Anhui Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Hepaticojejunostomy and T-tube drainage in people with Sphincter of Oddi Laxity, run by xpgeng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bao F Liu, doctor (+8613515662646, liufubao88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone recurrence rate (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.