CholecystitisNCT04242394
If Chronic Gallbladder Diseases Increase the Incidence of PEC
An observational study of Cholecystitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 3 sites in China.
Trial summary
This is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 1,019 participants
- Where
- 3 sitesChina
- Study dates
- 14 Feb 2020to 16 Nov 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Common bile duct stone ERCP patients with gallbladder in situ
Who may be able to join
- ERCP patients with gallbladder in situ
Who cannot join
- Acute cholecystitis before surgery
- Gallbladder has been removed
- Gastrointestinal reconstruction
- Unwillingness or inability to consent for the study
- Unstable vital signs Coagulation dysfunction (INR>1.5)
- Low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock Biliary- duodenal fistula confirmed during ERCP
- Pregnant women or breastfeeding
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chinese herb medicine hospital of Longnan City
Longnan, Gansu, 746000
The first hospital of Tianshui
Tianshui, Gansu, 741000
Wuwei turmour hospital
Wuwei, Gansu, 733000
About this study
Official title: If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis（a Prospective Multi-center Cohort Study)
This is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC)
Read the detailed description
Endoscopic Retrograde Choledochopancreatography(ERCP) has the advantages of less injury and faster recovery for common bile duct stone patients. However, according to our retrospective study, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis which often requires emergency intervention, when patients combined with chronic gallbladder diseases, such as chronic cholecystitis, asymptomatic gallstones, and gallbladder wall thickness, the incidence of PEC will increase accordingly. The aim of this study is to observe if chronic gallbladder disease will increase the occurence of PEC and develop a high-risk PEC model.
- Conditions
- Cholecystitis
- Being tested
- ERCP
- Keywords
- ERCP, Acute purulent cholecystitis, Bile duct stone, Post-ERCP-Choledocholithiasis PEC
- Medical subject headings
- Cholecystitis, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Routine ERCP procedures with gallbladder in situ patient
| Study group | Role | What they receive |
|---|---|---|
| Chronic gallbladder diseases | Routine ERCP participants with chronic gallbladder diseases Receives: Procedure: ERCP | |
| Without Chronic gallbladder disease | Routine ERCP participants without chronic gallbladder diseases Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Acute PEC(post-ERCP-cholecystitis )
When the PEC occurs, with right upper abdominal pain, White Blood Cell increasing, gallbladder wall ≥4mm or crudely, temperature might be more than 38 degree centigrade
Measured: 1month
Secondary outcomes (3)
Number of Pancreatitis
Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.
Measured: 1month
Number of Cholangitis
Temperature should be more than 38 #, right upper abdominal pain, chills or WBC≥10
Measured: 1 month
Number of Perforation
Typical abdominal pain,abdominal muscle tension, tenderness, evidence of free gas in abdominal cavity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start14 Feb 2020
- Primary completion16 Nov 2024
- Study completion16 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies 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
- Prospective
- Enrolment
- 1,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D., Ph. D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242394
- Sponsor's protocol ID
- Chronic gallbladder disease
- Status last verified
- Dec 2025
- First submitted
- 22 Jan 2020
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao J, Ding X, Wu H, Shen Y, Zheng R, Peng C, Wang L, Zou X. Classification of the cystic duct patterns and endoscopic transpapillary cannulation of the gallbladder to prevent post-ERCP cholecystitis. BMC Gastroenterol. 2019 Aug 5;19(1):139. doi: 10.1186/s12876-019-1053-6.
PubMed 31382888Cao J, Peng C, Ding X, Shen Y, Wu H, Zheng R, Wang L, Zou X. Risk factors for post-ERCP cholecystitis: a single-center retrospective study. BMC Gastroenterol. 2018 Aug 22;18(1):128. doi: 10.1186/s12876-018-0854-3.
PubMed 30134864Jin B, Wang Y, Zhang X, Zhao J, He W, Jin K, Liu Z, Zhong R, Ma Y, Dong C, Lin Y, Zhu X, Zhu K, Zhang L, Yue P, Li S, Yuan J, Li X, Meng W. Identifying high-risk patients having ERCP as a day surgery with an online prediction platform: Multicohort validation of a machine learning model. Endosc Int Open. 2025 Dec 16;13:a27331387. doi: 10.1055/a-2733-1387. eCollection 2025.
PubMed 41567602
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis（a Prospective Multi-center Cohort Study)
- ClinicalTrials.gov ID
- NCT04242394
- Acronym / sponsor ID
- Chronic gallbladder disease
- Conditions
- Cholecystitis
- Keywords
- ERCP, Acute purulent cholecystitis, Bile duct stone, Post-ERCP-Choledocholithiasis PEC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,019 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 27 Jan 2020 (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 is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC)
Detailed description
Endoscopic Retrograde Choledochopancreatography(ERCP) has the advantages of less injury and faster recovery for common bile duct stone patients. However, according to our retrospective study, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis which often requires emergency intervention, when patients combined with chronic gallbladder diseases, such as chronic cholecystitis, asymptomatic gallstones, and gallbladder wall thickness, the incidence of PEC will increase accordingly. The aim of this study is to observe if chronic gallbladder disease will increase the occurence of PEC and develop a high-risk PEC model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic gallbladder diseases | – | Procedure: ERCPRoutine ERCP participants with chronic gallbladder diseases |
| Without Chronic gallbladder disease | – | Procedure: ERCPRoutine ERCP participants without chronic gallbladder diseases |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Common bile duct stone ERCP patients with gallbladder in situ
Key inclusion criteria (1 listed)
- ERCP patients with gallbladder in situ
Key exclusion criteria (8 listed)
- Acute cholecystitis before surgery
- Gallbladder has been removed
- Gastrointestinal reconstruction
- Unwillingness or inability to consent for the study
- Unstable vital signs Coagulation dysfunction (INR>1.5)
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 |
|---|---|---|
| ERCPRoutine ERCP procedures with gallbladder in situ patient | Procedure or surgery | Chronic gallbladder diseases, Without Chronic gallbladder disease |
Primary outcome
Number of Acute PEC(post-ERCP-cholecystitis )
Time frame: 1month
When the PEC occurs, with right upper abdominal pain, White Blood Cell increasing, gallbladder wall ≥4mm or crudely, temperature might be more than 38 degree centigrade
3 secondary outcomes
Number of Pancreatitis
Time frame: 1month
Number of Cholangitis
Time frame: 1 month
Number of Perforation
Time frame: 1 month
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 19 Dec 2025.
- Background: PubMed 31382888Cao J, Ding X, Wu H, Shen Y, Zheng R, Peng C, Wang L, Zou X. Classification of the cystic duct patterns and endoscopic transpapillary cannulation of the gallbladder to prevent post-ERCP cholecystitis. BMC Gastroenterol. 2019 Aug 5;19(1):139. doi: 10.1186/s12876-019-1053-6.
- Background: PubMed 30134864Cao J, Peng C, Ding X, Shen Y, Wu H, Zheng R, Wang L, Zou X. Risk factors for post-ERCP cholecystitis: a single-center retrospective study. BMC Gastroenterol. 2018 Aug 22;18(1):128. doi: 10.1186/s12876-018-0854-3.
- Derived from this study: PubMed 41567602Jin B, Wang Y, Zhang X, Zhao J, He W, Jin K, Liu Z, Zhong R, Ma Y, Dong C, Lin Y, Zhu X, Zhu K, Zhang L, Yue P, Li S, Yuan J, Li X, Meng W. Identifying high-risk patients having ERCP as a day surgery with an online prediction platform: Multicohort validation of a machine learning model. Endosc Int Open. 2025 Dec 16;13:a27331387. doi: 10.1055/a-2733-1387. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Wenbo Meng, M.D., Ph. D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 3 sites 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 8 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Number of Acute PEC(post-ERCP-cholecystitis ) (time frame: 1month). 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 NCT04242394, which also lists 3 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 19 Dec 2025.