Cholelithiasis Associated With Common Bile Duct StonesNCT07495111
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
A study testing Prophylactic pancreatic stent and rectal indomethacin alone in people with Cholelithiasis Associated With Common Bile Duct Stones, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary… 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?
- Prophylactic pancreatic stent and rectal indomethacin alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to Jun 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older;
- Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);
- Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
- Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;
- The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
- Patients with at least one of the following high-risk factors for post-ERCP pancreatitis (PEP): suspected sphincter of Oddi dysfunction (SOD), female sex, history of pancreatitis, difficult cannulation (defined as ≥5 cannulation attempts or ≥5 minutes of cannulation time), pancreatic duct contrast injection, age <35 years, non-dilated extrahepatic bile duct, no history of chronic pancreatitis, normal serum bilirubin, precut sphincterotomy, biliary balloon dilation, incomplete bile duct stone clearance, or intraductal ultrasound ;
- Patients who voluntarily provide signed informed consent.
Who cannot join
- Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;
- Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;
- Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;
- Patients with severe coagulation dysfunction (defined as an International Normalized Ratio [INR] >1.5) or significant thrombocytopenia (platelet count <50×10⁹/L);
- Pregnant women;
- Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure;
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- Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs);
- Patients with congenital or acquired absence of the rectum;
- Patients with severe acute pancreatitis
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: Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy for Cholelithiasis With Concomitant Choledocholithiasis
In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. The study aims to analyze the impact of pancreatic duct stent implantation on the incidence of post-ERCP pancreatitis in gallstone patients treated with ERCP-GPC by comparing the efficacy differences between the experimental and control groups. Additionally, the study investigate the effects of pancreatic duct stent placement post-ERCP on other postoperative complications, conduct a comparative analysis of the economic benefits of placing versus not placing pancreatic duct stents after ERCP, and develop effective clinical strategies for preventing pancreatitis after gallbladder-preserving stone extraction in gallstone patients.
- Being tested
- Prophylactic pancreatic stent, rectal indomethacin alone
- Keywords
- Cholelithiasis with Concomitant Choledocholithiasis, Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy, post-ERCP pancreatitis, Randomized Controlled Trial (RCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic pancreatic stentDevice
All procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although the technical approach, including the amount of time and effort expended for this purpose, was not standardized.All patients received 100mg indomethacin suppositories.
rectal indomethacin aloneDrug
rectal indomethacin was used alone in the control group
| Study group | Role | What they receive |
|---|---|---|
| Receive rectal indomethacin alone | Other | Not described Receives: Drug: rectal indomethacin alone |
| Combination of indomethacin plus a prophylactic pancreatic stent | Experimental | Not described Receives: Device: Prophylactic pancreatic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients with Post-ERCP Pancreatitis
If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis.
Measured: 24 hours to 72 hours after ERCP
Secondary outcomes (3)
The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis
The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of > 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention.
Measured: Within 1 months after ERCP
Clinical Success Rate
Complete removal of gallbladder stones.
Measured: Within 1 months after ERCP
The Proportion of Patients with Other Complications
Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc.
Measured: Within 6 months after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Dec 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Linyi People's Hospital, Rizhao People's Hospital, Taian City Central Hospital, Shandong Province Third hospital, Binzhou Medical University, Liaocheng People's Hospital, Weifang People's Hospital, Central Hospital of Zibo, Qianfoshan Hospital, Qilu Hospital of Shandong University (Qingdao), Qingdao Municipal Hospital, Shengli Oilfield Hospital, The Second Hospital of Shandong University, Dezhou Hospital Qilu Hospital of Shandong University
- Responsible party
- Sponsor
- Investigators
- Tao Yu, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495111
- Sponsor's protocol ID
- 2025SDU-QILU-2
- 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
- Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy for Cholelithiasis With Concomitant Choledocholithiasis
- ClinicalTrials.gov ID
- NCT07495111
- Acronym / sponsor ID
- 2025SDU-QILU-2
- Keywords
- Cholelithiasis with Concomitant Choledocholithiasis, Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy, post-ERCP pancreatitis, Randomized Controlled Trial (RCT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Linyi People's Hospital, Rizhao People's Hospital, Taian City Central Hospital, Shandong Province Third hospital, Binzhou Medical University, Liaocheng People's Hospital, Weifang People's Hospital, Central Hospital of Zibo, Qianfoshan Hospital, Qilu Hospital of Shandong University (Qingdao), Qingdao Municipal Hospital, Shengli Oilfield Hospital, The Second Hospital of Shandong University, Dezhou Hospital Qilu Hospital of Shandong University
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Mar 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.
In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. The study aims to analyze the impact of pancreatic duct stent implantation on the incidence of post-ERCP pancreatitis in gallstone patients treated with ERCP-GPC by comparing the efficacy differences between the experimental and control groups. Additionally, the study investigate the effects of pancreatic duct stent placement post-ERCP on other postoperative complications, conduct a comparative analysis of the economic benefits of placing versus not placing pancreatic duct stents after ERCP, and develop effective clinical strategies for preventing pancreatitis after gallbladder-preserving stone extraction in gallstone patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive rectal indomethacin alone | Other | Drug: rectal indomethacin alone |
| Combination of indomethacin plus a prophylactic pancreatic stent | Experimental | Device: Prophylactic pancreatic stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years or older;
- Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);
- Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
- Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;
- The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
Key exclusion criteria (9 listed)
- Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;
- Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;
- Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;
- Patients with severe coagulation dysfunction (defined as an International Normalized Ratio [INR] >1.5) or significant thrombocytopenia (platelet count <50×10⁹/L);
- Pregnant women;
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 |
|---|---|---|
| Prophylactic pancreatic stentAll procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although the technical approach, including the amount of time and effort expended for this purpose, was not standardized.All patients received 100mg indomethacin suppositories. | Device | Combination of indomethacin plus a prophylactic pancreatic stent |
| rectal indomethacin alonerectal indomethacin was used alone in the control group | Drug | Receive rectal indomethacin alone |
Primary outcome
The Proportion of Patients with Post-ERCP Pancreatitis
Time frame: 24 hours to 72 hours after ERCP
If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis.
3 secondary outcomes
The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis
Time frame: Within 1 months after ERCP
Clinical Success Rate
Time frame: Within 1 months after ERCP
The Proportion of Patients with Other Complications
Time frame: Within 6 months after ERCP
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
RecruitingObservational study
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
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?
A study testing Prophylactic pancreatic stent and rectal indomethacin alone in people with 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 7 inclusion and 9 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?
The Proportion of Patients with Post-ERCP Pancreatitis (time frame: 24 hours to 72 hours after ERCP). 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.