HepatolithiasisNCT06839612
Evaluation of the Efficacy of the Two-point Method in Percutaneous Transhepatic Choledoscopy and the Influence of the Long-term Recurrence of Hepatolithiasis
A study testing Two-point method and Conventional PTCS in people with Hepatolithiasis and Endoscopy, Digestive System, run by Shengjing Hospital.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。The main questions it aims to answer are: ① By comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatolithiasis, Endoscopy, Digestive System
- What is being tested?
- Two-point method and Conventional PTCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 20 Jan 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- PTCS were only used for the treatment of hepatolithiasis
- patients receiving PTCS for the first time.
Who cannot join
- PTCD failure and withdrawal from treatment due to patients' subjective wishes were excluded.
About this study
The goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。The main questions it aims to answer are:
① By comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the clinical effect of the two methods was judged.
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② To analyze the probability of short-term complications of the two-point method during the operation and to judge its safety.
③ Patients were followed up after the two-point method to determine the recurrence rate of stones and the probability of long-term complications.
The researchers will compare the two-point method with conventional PTCS to evaluate its effectiveness.
- Conditions
- Hepatolithiasis, Endoscopy, Digestive System
- Being tested
- Two-point method, Conventional PTCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-point methodProcedure or surgery
In the two-point method, the distal end of the drainage tube was passed over the duodenal and intestinal lumen of the common bile duct during PTCD operation. In the process of sinus dilation, guide wire was sent into the intestinal lumen through the drainage tube, and then the drainage tube was inserted into the intestinal lumen with the extract forceps under the duodenoscope in reverse order to drag the drainage tube into the intestinal lumen before being sent into the guide wire.Clamp the guide wire with the access pliers and slowly draw out the guide wire through the mouth. Expand the outer inlet skin.When the skin was 6mm, the epigastric PTCD tube was removed, the percutaneous nephrostomy dilator was placed through the guide wire, and the patient was instructed to be drawn by the assistant.The mouth end of the guide wire, the surgeon pulls the other end of the guide wire, so that the two ends of the guide wire fix in vitro to form a higher tension to Expand the skin.
Conventional PTCSProcedure or surgery
PTCS can be divided into three steps: PTCD, sinus dilation, and lithotomy. In PTCD, we first performed intraoperative fluoroscopy, and punctured the biliary tract at a relatively straight Angle with the target biliary tract as far as possible. The distal end of the indenture drainage tube was inserted into the duodeno-intestinal cavity through the end of the common bile duct. The PTCD drainage tube was indwelled for 3-5 days.When the sinus was mature, we used dilated sheath tubes to dilate the sinus to 14-18Fr at a time, and used the working channel established by the choledochoscope to carry out net basket stone extraction. If large diameter stones were difficult to be extracted through the net basket, mechanical lithotomy was adopted to solve the problem, and conventional anti-inflammation was adopted in all patients after surgery. Cholangiography or epigastric CT were used to confirm complete removal of the stones after lithotomy.
| Study group | Role | What they receive |
|---|---|---|
| Two point method | Experimental | Not described Receives: Procedure: Two-point method |
| Conventional PTCS | Active comparator | Not described Receives: Procedure: Conventional PTCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Measured: up to 1 week
Clinical success rate
Measured: up to 1 week
Stone recurrence rate
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Bleeding
Measured: up to 2 weeks
Liver abscess
Measured: up to 2 weeks
Cholangitis
Measured: up to 2 weeks
Bile leakage
Measured: up to 2 weeks
Pancreatitis
Measured: up to 2 weeks
Thoracic complication
Measured: up to 2 weeks
Iatrogenic injury
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jan 2013
- Primary completion31 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatolithiasisStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengyu Wang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839612
- Sponsor's protocol ID
- Z023121604
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Two-point Method in Percutaneous Transhepatic Choledoscopy and the Influence of the Long-term Recurrence of Hepatolithiasis
- ClinicalTrials.gov ID
- NCT06839612
- Acronym / sponsor ID
- Z023121604
- Conditions
- Hepatolithiasis, Endoscopy, Digestive System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 21 Feb 2025 (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 goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。The main questions it aims to answer are:
① By comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the clinical effect of the two methods was judged.
② To analyze the probability of short-term complications of the two-point method during the operation and to judge its safety.
③ Patients were followed up after the two-point method to determine the recurrence rate of stones and the probability of long-term complications.
The researchers will compare the two-point method with conventional PTCS to evaluate its effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two point method | Experimental | Procedure: Two-point method |
| Conventional PTCS | Active comparator | Procedure: Conventional PTCS |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- PTCS were only used for the treatment of hepatolithiasis
- patients receiving PTCS for the first time.
Key exclusion criteria (1 listed)
- PTCD failure and withdrawal from treatment due to patients' subjective wishes were excluded.
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 |
|---|---|---|
| Two-point methodIn the two-point method, the distal end of the drainage tube was passed over the duodenal and intestinal lumen of the common bile duct during PTCD operation. In the process of sinus dilation, guide wire was sent into the intestinal lumen through the drainage tube, and then the drainage tube was inserted into the intestinal lumen with the extract forceps under the duodenoscope in reverse order to drag the drainage tube into the intestinal lumen before being sent into the guide wire.Clamp the guide wire with the access pliers and slowly draw out the guide wire through the mouth. Expand the outer inlet skin.When the skin was 6mm, the epigastric PTCD tube was removed, the percutaneous nephrostomy dilator was placed through the guide wire, and the patient was instructed to be drawn by the assistant.The mouth end of the guide wire, the surgeon pulls the other end of the guide wire, so that the two ends of the guide wire fix in vitro to form a higher tension to Expand the skin. | Procedure or surgery | Two point method |
| Conventional PTCSPTCS can be divided into three steps: PTCD, sinus dilation, and lithotomy. In PTCD, we first performed intraoperative fluoroscopy, and punctured the biliary tract at a relatively straight Angle with the target biliary tract as far as possible. The distal end of the indenture drainage tube was inserted into the duodeno-intestinal cavity through the end of the common bile duct. The PTCD drainage tube was indwelled for 3-5 days.When the sinus was mature, we used dilated sheath tubes to dilate the sinus to 14-18Fr at a time, and used the working channel established by the choledochoscope to carry out net basket stone extraction. If large diameter stones were difficult to be extracted through the net basket, mechanical lithotomy was adopted to solve the problem, and conventional anti-inflammation was adopted in all patients after surgery. Cholangiography or epigastric CT were used to confirm complete removal of the stones after lithotomy. | Procedure or surgery | Conventional PTCS |
Primary outcome
Technical success rate
Time frame: up to 1 week
Clinical success rate
Time frame: up to 1 week
Stone recurrence rate
Time frame: through study completion, an average of 1 year
7 secondary outcomes
Bleeding
Time frame: up to 2 weeks
Liver abscess
Time frame: up to 2 weeks
Cholangitis
Time frame: up to 2 weeks
Bile leakage
Time frame: up to 2 weeks
Pancreatitis
Time frame: up to 2 weeks
Thoracic complication
Time frame: up to 2 weeks
Iatrogenic injury
Time frame: up to 2 weeks
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 21 Feb 2025.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Two-point method and Conventional PTCS in people with Hepatolithiasis and Endoscopy, Digestive System, run by Shengjing Hospital.
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 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 21 Feb 2025. 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?
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?
Technical success rate (time frame: up to 1 week). 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?
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 21 Feb 2025.