CholecystitisNCT04234126
The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status
An observational study of Cholecystitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
In this retrospective study, the investigators evaluate the relationship of post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor. 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
- 1,117 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2020to 18 Nov 2021
- 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: Routine ERCP patients with CBD stones
Who may be able to join
- Routine ERCP for CBD stone patients with gallbladder in situ
Who cannot join
- Unwillingness or inability to consent for the study
- Unstable vital signs Coagulation dysfunction (INR>1.5) and low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
- Any Prior surgery for CBD including ERCP
- 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
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: Does the Gallbladder Status Influence the Occurence of Post-Endoscopic Retrograde Choledochopancreatography(ERCP) -Choledocholithiasis
In this retrospective study, the investigators evaluate the relationship of post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.
Read the detailed description
When patients have common bile duct(CBD) stones, ERCP is widely used for stone extraction instead of clinical operation. ERCP has many advantages like less injury or faster recovery. However, according to literature, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis, which often requires emergency intervention, therefore, it is necessary to know if the gallbladder status(chronic disease) is one of the important risk factors of PEC like the gallbladder wall thickness, chronic cholecystitis, polyps,crudely or calculus.
.
- Conditions
- Cholecystitis
- Being tested
- ERCP
- Keywords
- ERCP, Acute purulent cholecystitis, Bile duct stone, PEC(post-ERCP-choledocholithiasis)
- 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 for CBD stone with the gallbladder in situ, the chronic gallbladder status was defined as gallbladder wall thickness≥4mm, chronic cholecystitis, polyps,crudely or calculus .
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, the temperature should be more than 38 celsius degree, right upper abdominal pain, the total amount of the White Blood Cell (WBC) is above normal for the patients who with the gallbladder wall thickness under ultrasound examination.
Measured: 1 month
Secondary outcomes (4)
Number of Participants with 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: 1 month
Number of Participants with Cholangitis
Temperature should be more than 38 celsius degree, chills, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal
Measured: 1 month
Number of Participants with Perforation
Typical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting
Measured: 1 month
Number of Participants with bile duct stents
If it is necessary to get the patients drainage, Number of Participants with stents or endoscopic nasobiliary drainage (ENBD) should be recorded
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 posted21 Jan 2020
- Study start31 Jan 2020
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
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
- Retrospective
- Enrolment
- 1,117 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
- NCT04234126
- Sponsor's protocol ID
- Gallbladder status and PEC
- Status last verified
- Nov 2021
- First submitted
- 13 Jan 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31382888Jin 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 41567602Zhang X, Yue P, Zhang J, Yang M, Chen J, Zhang B, Luo W, Wang M, Da Z, Lin Y, Zhou W, Zhang L, Zhu K, Ren Y, Yang L, Li S, Yuan J, Meng W, Leung JW, Li X. A novel machine learning model and a public online prediction platform for prediction of post-ERCP-cholecystitis (PEC). EClinicalMedicine. 2022 May 13;48:101431. doi: 10.1016/j.eclinm.2022.101431. eCollection 2022 Jun.
PubMed 35706483
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Gallbladder Status Influence the Occurence of Post-Endoscopic Retrograde Choledochopancreatography(ERCP) -Choledocholithiasis
- ClinicalTrials.gov ID
- NCT04234126
- Acronym / sponsor ID
- Gallbladder status and PEC
- Conditions
- Cholecystitis
- Keywords
- ERCP, Acute purulent cholecystitis, Bile duct stone, PEC(post-ERCP-choledocholithiasis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,117 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 21 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.
In this retrospective study, the investigators evaluate the relationship of post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.
Detailed description
When patients have common bile duct(CBD) stones, ERCP is widely used for stone extraction instead of clinical operation. ERCP has many advantages like less injury or faster recovery. However, according to literature, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis, which often requires emergency intervention, therefore, it is necessary to know if the gallbladder status(chronic disease) is one of the important risk factors of PEC like the gallbladder wall thickness, chronic cholecystitis, polyps,crudely or calculus.
.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Routine ERCP patients with CBD stones
Key inclusion criteria (1 listed)
- Routine ERCP for CBD stone patients with gallbladder in situ
Key exclusion criteria (6 listed)
- Unwillingness or inability to consent for the study
- Unstable vital signs Coagulation dysfunction (INR>1.5) and low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
- Any Prior surgery for CBD including ERCP
- 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
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 for CBD stone with the gallbladder in situ, the chronic gallbladder status was defined as gallbladder wall thickness≥4mm, chronic cholecystitis, polyps,crudely or calculus . | Procedure or surgery | – |
Primary outcome
Number of Acute PEC(post-ERCP-cholecystitis )
Time frame: 1 month
When the PEC occurs, the temperature should be more than 38 celsius degree, right upper abdominal pain, the total amount of the White Blood Cell (WBC) is above normal for the patients who with the gallbladder wall thickness under ultrasound examination.
4 secondary outcomes
Number of Participants with Pancreatitis
Time frame: 1 month
Number of Participants with Cholangitis
Time frame: 1 month
Number of Participants with Perforation
Time frame: 1 month
Number of Participants with bile duct stents
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 Nov 2021.
- Results publication: 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.
- 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.
- Derived from this study: PubMed 35706483Zhang X, Yue P, Zhang J, Yang M, Chen J, Zhang B, Luo W, Wang M, Da Z, Lin Y, Zhou W, Zhang L, Zhu K, Ren Y, Yang L, Li S, Yuan J, Meng W, Leung JW, Li X. A novel machine learning model and a public online prediction platform for prediction of post-ERCP-cholecystitis (PEC). EClinicalMedicine. 2022 May 13;48:101431. doi: 10.1016/j.eclinm.2022.101431. eCollection 2022 Jun.
- 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
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 Cholecystitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province 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 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: finished, as of the sponsor's last update on 19 Nov 2021. 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?
Number of Acute PEC(post-ERCP-cholecystitis ) (time frame: 1 month). 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 NCT04234126, 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 Nov 2021.