Cholelithiasis Associated With Common Bile Duct StonesNCT07413068
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
An observational study of Cholelithiasis Associated With Common Bile Duct Stones, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis Associated With Common Bile Duct Stones
- What is being tested?
- endoscopic transpapillary gallbladder-preserving, ERCP plus Laparoscopic Cholecystectomy and Conservative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to Dec 2030
- How long will I take part?
- 36 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with cholelithiasis with concomitant choledocholithiasis
Who may be able to join
- Patients over the age of 18 years;
- Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;
- Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);
- Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
- The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
- Voluntary provision of signed informed consent.
Who cannot join
- Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;
- Unable to undergo endoscopic interventions for various reasons;
- Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;
- Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;
- Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) > 1.5 or patients with significant thrombocytopenia (platelet count < 50 × 10⁹/L);
- Pregnant women;
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, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
About this study
Official title: Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.
Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.
- Being tested
- endoscopic transpapillary gallbladder-preserving, ERCP plus Laparoscopic Cholecystectomy, Conservative treatment
- Keywords
- Cholelithiasis with Concomitant Choledocholithiasis, Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy, ERCP plus Laparoscopic Cholecystectomy, Conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic transpapillary gallbladder-preservingProcedure or surgery
Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
ERCP plus Laparoscopic CholecystectomyProcedure or surgery
Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
Conservative treatmentDrug
Also called Conservative treatment group
Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy | The patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy Receives: Procedure: endoscopic transpapillary gallbladder-preserving | |
| ERCP plus Laparoscopic Cholecystectomy | The patients intend to receive ERCP plus laparoscopic cholecystectomy Receives: Procedure: ERCP plus Laparoscopic Cholecystectomy | |
| Conservative Treatment | After removal of common bile duct stone via ERCP,neither ERCP nor laparoscopic cholecystectomy will be carried out to treat cholecystolithiasis. Receives: Drug: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.
Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.
Measured: From enrollment to 3 years after the end of treatment
Secondary outcomes (2)
Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis.
Compare the gallbladder stone clearance rate and bile duct stone clearance rate among the three groups; meanwhile, record the rates of successful gallbladder access establishment via FCMS and successful guidewire cannulation into the gallbladder in the gallbladder-preserving cholecystolithotomy group, so as to clarify the clinical success rate and technical success rate of this technique.
Measured: From enrollment to 3 years after the end of treatment
Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment.
Record duration of Hospitalization and total Medical Expenses of the three groups then calculate them as total medical expenses / duration of hospitalization (Unit: [e.g., CNY/USD] per day).It can reflect the average daily inpatient economic cost for each treatment, enabling integrated comparison of economic efficiency across the three groups.
Measured: From enrollment to 3 years after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Dec 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholelithiasis Associated With Common Bile Duct StonesStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Shandong Province Third hospital, Qingdao Municipal Hospital, Shengli Oilfield Hospital, Liaocheng People's Hospital, Binzhou Medical University, Weifang People's Hospital, Taian City Central Hospital, Qianfoshan Hospital, Linyi People's Hospital, Qilu Hospital of Shandong University (Qingdao), Central Hospital of Zibo, The Second Hospital of Shandong University, Dezhou Hospital Qilu Hospital of Shandong University, Rizhao People's Hospital
- Responsible party
- Sponsor
- Investigators
- Tao Yu, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413068
- Sponsor's protocol ID
- 2025SDU-QILU-1
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2026
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.
- ClinicalTrials.gov ID
- NCT07413068
- Acronym / sponsor ID
- 2025SDU-QILU-1
- Keywords
- Cholelithiasis with Concomitant Choledocholithiasis, Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy, ERCP plus Laparoscopic Cholecystectomy, Conservative treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Shandong Province Third hospital, Qingdao Municipal Hospital, Shengli Oilfield Hospital, Liaocheng People's Hospital, Binzhou Medical University, Weifang People's Hospital, Taian City Central Hospital, Qianfoshan Hospital, Linyi People's Hospital, Qilu Hospital of Shandong University (Qingdao), Central Hospital of Zibo, The Second Hospital of Shandong University, Dezhou Hospital Qilu Hospital of Shandong University, Rizhao People's Hospital
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Feb 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.
Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy | – | Procedure: endoscopic transpapillary gallbladder-preservingThe patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy |
| ERCP plus Laparoscopic Cholecystectomy | – | Procedure: ERCP plus Laparoscopic CholecystectomyThe patients intend to receive ERCP plus laparoscopic cholecystectomy |
| Conservative Treatment | – | Drug: Conservative treatmentAfter removal of common bile duct stone via ERCP,neither ERCP nor laparoscopic cholecystectomy will be carried out to treat cholecystolithiasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cholelithiasis with concomitant choledocholithiasis
Key inclusion criteria (6 listed)
- Patients over the age of 18 years;
- Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;
- Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);
- Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
- The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
Key exclusion criteria (6 listed)
- Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;
- Unable to undergo endoscopic interventions for various reasons;
- Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;
- Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;
- Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) > 1.5 or patients with significant thrombocytopenia (platelet count < 50 × 10⁹/L);
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 |
|---|---|---|
| endoscopic transpapillary gallbladder-preservingBased on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving | Procedure or surgery | Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy |
| ERCP plus Laparoscopic CholecystectomyBased on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy | Procedure or surgery | ERCP plus Laparoscopic Cholecystectomy |
| Conservative treatmentAlso: Conservative treatment groupBased on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care. | Drug | Conservative Treatment |
Primary outcome
Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.
Time frame: From enrollment to 3 years after the end of treatment
Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.
2 secondary outcomes
Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis.
Time frame: From enrollment to 3 years after the end of treatment
Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment.
Time frame: From enrollment to 3 years after the end of treatment
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 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Cholelithiasis Associated With Common Bile Duct Stones
Recruiting
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
Cholelithiasis Associated With Common Bile Duct Stones
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.
Tao Yu, MD principal investigator
Qilu Hospital of Shandong University
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 Cholelithiasis Associated With Common Bile Duct Stones, run by Qilu Hospital of Shandong 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 May 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?
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 Zhen Li, MD (18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications. (time frame: From enrollment to 3 years after the end of treatment). 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 18 May 2026.