Common Bile Duct CalculiNCT07345663
Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage
An observational study of Common Bile Duct Calculi, run by Yantai Affiliated Hospital of Binzhou Medical University at 1 site in China.
Trial summary
This observational study aims to compare two techniques for closing the common bile duct incision (choledochotomy) after laparoscopic common bile duct exploration (LCBDE) with T-tube drainage. Interrupted suturing is commonly used, but it can be time-consuming during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Calculi
- What is being tested?
- Modified continuous suture and Interrupted suture
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients who underwent laparoscopic common bile duct exploration (LCBDE) with T-tube drainage at our institution between January 2020 and November 2024. Inclusion criteria include patients who had choledochotomy closure performed with either modified continuous suturing (MCS) or interrupted suturing (IS). Patients were retrospectively reviewed, and baseline characteristics such as age, gender, stone burden, and ASA classification were collected. Exclusion criteria include patients with incomplete data or those who underwent procedures other than LCBDE.
Who may be able to join
- (1) age ≥18 years; (2) imaging-confirmed CBDS; (3) intraoperative placement of a T-tube; and (4) Common bile duct (CBD) diameter ≥6 mm
Who cannot join
- coagulopathy, severe cognitive impairment, multiple intrahepatic stones, biliary stricture, malignancy, liver cirrhosis, severe acute pancreatitis (BISAP score ≥3), and acute cholangitis complicated by septic shock, classified as Grade III according to the Tokyo Guidelines 2018
Trial locations and contacts
1 site in 1 country.
China1 site
Yantai affiliated hospital of Binzhou Medical University
Yantai, Shandong, 264100
About this study
Official title: Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage: A Propensity Score-Matched Cohort Study
This observational study aims to compare two techniques for closing the common bile duct incision (choledochotomy) after laparoscopic common bile duct exploration (LCBDE) with T-tube drainage. Interrupted suturing is commonly used, but it can be time-consuming during laparoscopic surgery. A modified continuous suturing approach may improve efficiency while maintaining safety.
We will retrospectively review patients who underwent LCBDE with T-tube drainage at our institution. Patients will be grouped according to the choledochotomy closure technique used during routine clinical care (modified continuous suturing versus conventional interrupted closure). To reduce baseline differences between groups, propensity score matching based on preoperative and intraoperative characteristics will be applied.
The primary outcome is choledochotomy closure time. Secondary outcomes include total operative time and perioperative safety outcomes, such as bile leakage and other postoperative complications, as well as short-term postoperative recovery indicators. This study will provide comparative evidence on operative efficiency and safety of continuous versus interrupted choledochotomy closure in the setting of LCBDE with T-tube drainage.
- Conditions
- Common Bile Duct Calculi
- Being tested
- Modified continuous suture, Interrupted suture
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified continuous sutureProcedure or surgery
Modified continuous suture was performed using 4-0 knotless barbed polydioxanone sutures (Quill™, Surgical Specialties Corporation). A continuous full-thickness suture was placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm. After completion of the continuous closure, 1-2 reinforcing stitches were placed in the opposite direction (from proximal to distal), and the suture was secured by tying to the tail end of the initial stitch.
Interrupted sutureProcedure or surgery
Interrupted suture was performed using 4-0 antibacterial monofilament polydioxanone sutures (PDS™ Plus, Ethicon, LLC). Interrupted sutures were placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm; each stitch was tied separately. An additional 1-2 reinforcing stitches (transverse or figure-of-eight) were placed around the T-tube exit site to enhance apposition between the choledochotomy edge and the tube wall.
| Study group | Role | What they receive |
|---|---|---|
| Modified Continuous Suturing | Not described Receives: Procedure: Modified continuous suture | |
| Interrupted Suturing | Not described Receives: Procedure: Interrupted suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choledochotomy Closure Time
The time taken to complete choledochotomy closure, from the beginning of suturing to the completion of the final knot. This measure is recorded in minutes for each patient.
Measured: Closure time is measured intraoperatively during the procedure and recorded once closure is complete.
Secondary outcomes (1)
Total Operative Time
The total time from the initiation of the procedure to the completion of the surgery. This includes all steps of the surgery, from incision to closure.
Measured: The total operative time is measured during the procedure, from the first incision to the final closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2020
- Primary completion30 Nov 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yantai Affiliated Hospital of Binzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyou Ji, Yantai Affiliated Hospital of Binzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345663
- Sponsor's protocol ID
- LW-202601
- Other IDs
- F-KY-0022-20220325-01
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage: A Propensity Score-Matched Cohort Study
- ClinicalTrials.gov ID
- NCT07345663
- Acronym / sponsor ID
- LW-202601
- Conditions
- Common Bile Duct Calculi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Yantai Affiliated Hospital of Binzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Jan 2026 (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.
This observational study aims to compare two techniques for closing the common bile duct incision (choledochotomy) after laparoscopic common bile duct exploration (LCBDE) with T-tube drainage. Interrupted suturing is commonly used, but it can be time-consuming during laparoscopic surgery. A modified continuous suturing approach may improve efficiency while maintaining safety.
We will retrospectively review patients who underwent LCBDE with T-tube drainage at our institution. Patients will be grouped according to the choledochotomy closure technique used during routine clinical care (modified continuous suturing versus conventional interrupted closure). To reduce baseline differences between groups, propensity score matching based on preoperative and intraoperative characteristics will be applied.
The primary outcome is choledochotomy closure time. Secondary outcomes include total operative time and perioperative safety outcomes, such as bile leakage and other postoperative complications, as well as short-term postoperative recovery indicators. This study will provide comparative evidence on operative efficiency and safety of continuous versus interrupted choledochotomy closure in the setting of LCBDE with T-tube drainage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Continuous Suturing | – | Procedure: Modified continuous suture |
| Interrupted Suturing | – | Procedure: Interrupted suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients who underwent laparoscopic common bile duct exploration (LCBDE) with T-tube drainage at our institution between January 2020 and November 2024. Inclusion criteria include patients who had choledochotomy closure performed with either modified continuous suturing (MCS) or interrupted suturing (IS). Patients were retrospectively reviewed, and baseline characteristics such as age, gender, stone burden, and ASA classification were collected. Exclusion criteria include patients with incomplete data or those who underwent procedures other than LCBDE.
Key inclusion criteria (1 listed)
- (1) age ≥18 years; (2) imaging-confirmed CBDS; (3) intraoperative placement of a T-tube; and (4) Common bile duct (CBD) diameter ≥6 mm
Key exclusion criteria (1 listed)
- coagulopathy, severe cognitive impairment, multiple intrahepatic stones, biliary stricture, malignancy, liver cirrhosis, severe acute pancreatitis (BISAP score ≥3), and acute cholangitis complicated by septic shock, classified as Grade III according to the Tokyo Guidelines 2018
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 continuous sutureModified continuous suture was performed using 4-0 knotless barbed polydioxanone sutures (Quill™, Surgical Specialties Corporation). A continuous full-thickness suture was placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm. After completion of the continuous closure, 1-2 reinforcing stitches were placed in the opposite direction (from proximal to distal), and the suture was secured by tying to the tail end of the initial stitch. | Procedure or surgery | Modified Continuous Suturing |
| Interrupted sutureInterrupted suture was performed using 4-0 antibacterial monofilament polydioxanone sutures (PDS™ Plus, Ethicon, LLC). Interrupted sutures were placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm; each stitch was tied separately. An additional 1-2 reinforcing stitches (transverse or figure-of-eight) were placed around the T-tube exit site to enhance apposition between the choledochotomy edge and the tube wall. | Procedure or surgery | Interrupted Suturing |
Primary outcome
Choledochotomy Closure Time
Time frame: Closure time is measured intraoperatively during the procedure and recorded once closure is complete.
The time taken to complete choledochotomy closure, from the beginning of suturing to the completion of the final knot. This measure is recorded in minutes for each patient.
1 secondary outcome
Total Operative Time
Time frame: The total operative time is measured during the procedure, from the first incision to the final closure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Calculi, run by Yantai Affiliated Hospital of Binzhou Medical University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choledochotomy Closure Time (time frame: Closure time is measured intraoperatively during the procedure and recorded once closure is complete.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.