Common Bile Duct CalculiNCT06011941
Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
A study testing Modified laparoscopic transcystic biliary drainage in people with Common Bile Duct Calculi and Acute; Cholecystitis, Choledocholithiasis, run by Peking University Third Hospital at 1 site in China.
Trial summary
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques. Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Common Bile Duct Calculi, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction
- What is being tested?
- Modified laparoscopic transcystic biliary drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age;
- Patients with gallbladder stones and known or expected concomitant bile duct stones;
- Informed consent.
Who cannot join
- Biliary drainage is already present, e.g. preoperative ENBD, PTCD;
- Women who are pregnant;
- Declined consent;
- Inability to follow the procedures of the study, e.g. due to language problems and psychological disorders of the participant;
- Morbid obesity (BMI > 40);
- IV-VI class of the American Society of Anesthesiologists physical status classification;
- Contraindications for general anesthesia or surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Lingfu Zhang
Beijing, None Selected, 100191
LINGFU ZHANG, +8613488693608, zhanglingfuzlf@126.com
About this study
Official title: Safety and Feasibility of Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Read more
Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube.
Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
Read the detailed description
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Then we developed a continued suture and circling manner by the V-Loc closure device (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the C-tube.
Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. Our modified path could avoid the compression of the C-tube by hepatic margin and hence decrease the dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence development and sinus-tract formation.
More importantly, this path could easily be available when the patient be placed in the prone position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube down to the duodenum to perform postoperative rendezvous technique.
Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
- Conditions
- Common Bile Duct Calculi, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction, Acute Cholangitis
- Being tested
- Modified laparoscopic transcystic biliary drainage
- Medical subject headings
- Gallstones, Cholecystitis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified laparoscopic transcystic biliary drainageProcedure or surgery
First, a needle was passed through a separate skin puncture wound 3 cm below the costal margin on the midaxillary line/posterior axillary line. Second, a lateral incision into the cystic duct was performed medially to allow insertion and embedding of the catheter. Third, a 7-Fr catheter was introduced through the abdominal wall via the cystic duct into the CBD. Fourth, if the position of the catheter inside the CBD was correct (the end of the tube reached the distal CBD but did not pass the papilla), the lateral incision of the cystic duct was closed by a V-Loc closure device using a single-layered, continuous suture in a circling manner to simultaneously cover and anchor the C-tube. After the procedure, an artificial fistula of 3 to 5 mm in length was formed.
| Study group | Role | What they receive |
|---|---|---|
| modified laparoscopic transcystic biliary drainage | Experimental | A 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. Receives: Procedure: Modified laparoscopic transcystic biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative overall morbidity
All outcome variables will be assessed according to internationally accepted standards if available, that is, the consensus definitions for surgical and medical complications according to the Clavien-Dindo classification.
Measured: 6 months
bile leakage
Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.
Measured: 6 months
Secondary outcomes (3)
anchoring time of the C-tube
the consumption of time from needle puncture to ending of C-tube ligation
Measured: 6 months
average daily drainage volume
the average volume of bile drainage per day
Measured: 6 months
early dislodgement of C-tube
the dislodgement of C-tube before intended removal.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct CalculiStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LINGFU ZHANG, Study chair, 北京大学第三医院
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011941
- Sponsor's protocol ID
- 81524
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang LF, Hou CS, Xu Z, Wang LX, Ling XF, Wang G, Cui L, Xiu DR. [Clinical effect of laparoscopic transcystic drainage combined with common bile duct exploration for the patients with difficult biliary stones]. Beijing Da Xue Xue Bao Yi Xue Ban. 2022 Dec 18;54(6):1185-1189. doi: 10.19723/j.issn.1671-167X.2022.06.021. Chinese.
PubMed 36533353Zhang YY, Wang G, Hou C, Xu Z, Wang L, Cui L, Ling X, Zhang L. Safety and effectiveness of modified laparoscopic transcystic biliary drainage in the treatment of choledocholithiasis: study protocol for a prospective single-arm clinical trial. BMJ Open. 2025 Apr 23;15(4):e089540. doi: 10.1136/bmjopen-2024-089540.
PubMed 40268483
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
- ClinicalTrials.gov ID
- NCT06011941
- Acronym / sponsor ID
- 81524
- Conditions
- Common Bile Duct Calculi, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction, Acute Cholangitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Aug 2023 (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.
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube.
Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
Detailed description
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Then we developed a continued suture and circling manner by the V-Loc closure device (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the C-tube.
Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. Our modified path could avoid the compression of the C-tube by hepatic margin and hence decrease the dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence development and sinus-tract formation.
More importantly, this path could easily be available when the patient be placed in the prone position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube down to the duodenum to perform postoperative rendezvous technique.
Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified laparoscopic transcystic biliary drainage | Experimental | Procedure: Modified laparoscopic transcystic biliary drainageA 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years of age;
- Patients with gallbladder stones and known or expected concomitant bile duct stones;
- Informed consent.
Key exclusion criteria (7 listed)
- Biliary drainage is already present, e.g. preoperative ENBD, PTCD;
- Women who are pregnant;
- Declined consent;
- Inability to follow the procedures of the study, e.g. due to language problems and psychological disorders of the participant;
- Morbid obesity (BMI > 40);
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 |
|---|---|---|
| Modified laparoscopic transcystic biliary drainageFirst, a needle was passed through a separate skin puncture wound 3 cm below the costal margin on the midaxillary line/posterior axillary line. Second, a lateral incision into the cystic duct was performed medially to allow insertion and embedding of the catheter. Third, a 7-Fr catheter was introduced through the abdominal wall via the cystic duct into the CBD. Fourth, if the position of the catheter inside the CBD was correct (the end of the tube reached the distal CBD but did not pass the papilla), the lateral incision of the cystic duct was closed by a V-Loc closure device using a single-layered, continuous suture in a circling manner to simultaneously cover and anchor the C-tube. After the procedure, an artificial fistula of 3 to 5 mm in length was formed. | Procedure or surgery | modified laparoscopic transcystic biliary drainage |
Primary outcome
postoperative overall morbidity
Time frame: 6 months
All outcome variables will be assessed according to internationally accepted standards if available, that is, the consensus definitions for surgical and medical complications according to the Clavien-Dindo classification.
bile leakage
Time frame: 6 months
Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.
3 secondary outcomes
anchoring time of the C-tube
Time frame: 6 months
average daily drainage volume
Time frame: 6 months
early dislodgement of C-tube
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 36533353Zhang LF, Hou CS, Xu Z, Wang LX, Ling XF, Wang G, Cui L, Xiu DR. [Clinical effect of laparoscopic transcystic drainage combined with common bile duct exploration for the patients with difficult biliary stones]. Beijing Da Xue Xue Bao Yi Xue Ban. 2022 Dec 18;54(6):1185-1189. doi: 10.19723/j.issn.1671-167X.2022.06.021. Chinese.
- Derived from this study: PubMed 40268483Zhang YY, Wang G, Hou C, Xu Z, Wang L, Cui L, Ling X, Zhang L. Safety and effectiveness of modified laparoscopic transcystic biliary drainage in the treatment of choledocholithiasis: study protocol for a prospective single-arm clinical trial. BMJ Open. 2025 Apr 23;15(4):e089540. doi: 10.1136/bmjopen-2024-089540.
- Individual participant dataSharing planned: No
Related trials for Common Bile Duct Calculi
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
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.
LINGFU ZHANG study chair
北京大学第三医院
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified laparoscopic transcystic biliary drainage in people with Common Bile Duct Calculi and Acute; Cholecystitis, Choledocholithiasis, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LINGFU ZHANG (+8613488693608, zhanglingfuzlf@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative overall morbidity (time frame: 6 months). The study lists 2 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 NCT06011941, which also lists 2 linked publications.
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 25 Aug 2023.