CholedocholithiasisNCT06676241
One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis
An observational study of Choledocholithiasis and Cholecystolithiasis, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis. Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Choledocholithiasis, Cholecystolithiasis, Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy and endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteRussia
- Study dates
- 13 Nov 2024to 5 Mar 2025
- 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 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Who may be able to join
- Informed consent from the patient, child or legal representative
- Age 0-80 years
- Acute cholecystitis
- Choledocholithiasis
- Intraoperative ERCP
- Preoperative ERCP followed by cholecystectomy
Who cannot join
- Unwillingness or inability to consent to the study
- Pregnancy
- Age > 80 years
- Previous ERCP or percutaneous transhepatic biliary drainage
- Anastomosis in the upper gastrointestinal tract
- Benign or malignant stricture
Show all 11Show fewer
- Preoperative comorbidities: gastrointestinal bleeding, severe liver disease, acute and chronic cholangitis, other known cholestatic hepatopancreatobiliary disease, septic shock.
- In combination with Mirizzi syndrome and intrahepatic bile duct stones
- Congenital anomaly of the biliary tract
- Malignant neoplasms
- Acute pancreatitis
Trial locations and contacts
1 site in 1 country.
Russia1 site
Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Moscow, Moscow Oblast, 142636
About this study
In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
Read the detailed description
Nowadays there is no gold standard for the treatment of choledocholithiasis combined with cholecystolithiasis in the pediatric population. The most common method for resolving the biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). In the adult practice, the approaches to the treatment of choledocholithiasis include the following items: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and LC after ERCP. Both LCBDE and LERV allow for the simultaneous treatment of cholecystocholedocholithiasis. However, a great number of medical institutions do not have an opportunity to use these methods due to the difficulties of implementation and the need for special training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis also remains a subject of debate. Numerous studies recommend early LC after ERCP. However, there are high risks of injury to the common bile duct and hepatic vessels against the background of acute inflammatory process in the area of hepatoduodenal ligament. In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with delayed laparoscopic cholecystectomy in children with cholecystocholedocholithiasis compared with one-stage cholangiopancreatography, endoscopic sphincterotomy and laparoscopic cholecystectomy in adults with cholecystocholedocholithiasis.
- Conditions
- Choledocholithiasis, Cholecystolithiasis, Cholangiopancreatography, Endoscopic Retrograde, Laparoscopic Cholecystectomy, Children, Acute Pancreatitis (AP)
- Being tested
- endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy, endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy
- Keywords
- Сholedocholelysis, Endoscopic retrograde cholangiopancreatography (ERCP)
- Medical subject headings
- Choledocholithiasis, Cholecystolithiasis, Pancreatitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomyProcedure or surgery
Also called Cholangiopancreatography, Laparoscopic
Initially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia.
endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomyProcedure or surgery
Also called Cholangiopancreatography, Laparoscopic
Initially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patient underwent the endoscopic procedure using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed on a delayed basis no earlier than 7 days after ERCP
| Study group | Role | What they receive |
|---|---|---|
| ERCP, EST and simultaneous LC | Patients aged 10-80 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia Receives: Procedure: endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy | |
| ERCP, EST and LC in a delayed manner | Patients aged 0-17 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed in a delayed manner, not earlier than 7 days after ERCP Receives: Procedure: endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of stones in the common bile duct
The diagnosis of the stone in the common bile duct.
Measured: 30 days after ERCP
Secondary outcomes (10)
Bleeding
decreased hemoglobin level, visual picture during endoscopic examination, positive stool for occult blood
Measured: 30 days after ERCP
Perforation
by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)
Measured: 30 days after ERCP
Bile leak
bile aspirated from the abdominal cavity
Measured: 30 days after ERCP
Acute cholangitis
intermittent chills, fever, increased proinflammatory blood markers after ERCP
Measured: 60 days after ERCP
Bile duct stricture
after ERCP
Measured: 1 year after ERCP
Time spent in hospital until discharge
Measured: from admission to hospital until the end of treatment (up to 8 weeks)
Technical success - success of the procedures as documented by a yes or no
Measured: 1 month
Duration of the laparoscopic cholecystectomy,min
Measured: From enrollment to the end of treatment (3 month)
Acute pancreatitis
at least two out of three criteria according to the classification developed by the INSPPIRE group
Measured: within 14 days after ERCP
Duration of the Endoscopic retrograde cholangiopancreatography
Measured: From enrollment to the end of treatment (3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start13 Nov 2024
- Primary completion20 Feb 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dmitriy А Pyhteev, PhD, Study director, Head of the Department of Pediatric SurgeryLeonid M Elin, Principal investigator, Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676241
- Sponsor's protocol ID
- 16/17.10.2024
- Status last verified
- Mar 2025
- First submitted
- 27 Oct 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A complete dataset can be provided upon reasoned request
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis
- ClinicalTrials.gov ID
- NCT06676241
- Acronym / sponsor ID
- 16/17.10.2024
- Conditions
- Choledocholithiasis, Cholecystolithiasis, Cholangiopancreatography, Endoscopic Retrograde, Laparoscopic Cholecystectomy, Children, Acute Pancreatitis (AP)
- Keywords
- Сholedocholelysis, Endoscopic retrograde cholangiopancreatography (ERCP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 6 Nov 2024 (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 study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
Detailed description
Nowadays there is no gold standard for the treatment of choledocholithiasis combined with cholecystolithiasis in the pediatric population. The most common method for resolving the biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). In the adult practice, the approaches to the treatment of choledocholithiasis include the following items: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and LC after ERCP. Both LCBDE and LERV allow for the simultaneous treatment of cholecystocholedocholithiasis. However, a great number of medical institutions do not have an opportunity to use these methods due to the difficulties of implementation and the need for special training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis also remains a subject of debate. Numerous studies recommend early LC after ERCP. However, there are high risks of injury to the common bile duct and hepatic vessels against the background of acute inflammatory process in the area of hepatoduodenal ligament. In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with delayed laparoscopic cholecystectomy in children with cholecystocholedocholithiasis compared with one-stage cholangiopancreatography, endoscopic sphincterotomy and laparoscopic cholecystectomy in adults with cholecystocholedocholithiasis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP, EST and simultaneous LC | – | Procedure: endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomyPatients aged 10-80 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia |
| ERCP, EST and LC in a delayed manner | – | Procedure: endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomyPatients aged 0-17 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed in a delayed manner, not earlier than 7 days after ERCP |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Key inclusion criteria (6 listed)
- Informed consent from the patient, child or legal representative
- Age 0-80 years
- Acute cholecystitis
- Choledocholithiasis
- Intraoperative ERCP
Key exclusion criteria (11 listed)
- Unwillingness or inability to consent to the study
- Pregnancy
- Age > 80 years
- Previous ERCP or percutaneous transhepatic biliary drainage
- Anastomosis in the upper gastrointestinal tract
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 retrograde cholangiopancreatography; laparoscopic cholecystectomyAlso: Cholangiopancreatography, LaparoscopicInitially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia. | Procedure or surgery | ERCP, EST and simultaneous LC |
| endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomyAlso: Cholangiopancreatography, LaparoscopicInitially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patient underwent the endoscopic procedure using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed on a delayed basis no earlier than 7 days after ERCP | Procedure or surgery | ERCP, EST and LC in a delayed manner |
Primary outcome
Recurrence of stones in the common bile duct
Time frame: 30 days after ERCP
The diagnosis of the stone in the common bile duct.
10 secondary outcomes
Bleeding
Time frame: 30 days after ERCP
Perforation
Time frame: 30 days after ERCP
Bile leak
Time frame: 30 days after ERCP
Acute cholangitis
Time frame: 60 days after ERCP
Bile duct stricture
Time frame: 1 year after ERCP
Time spent in hospital until discharge
Time frame: from admission to hospital until the end of treatment (up to 8 weeks)
Technical success - success of the procedures as documented by a yes or no
Time frame: 1 month
Duration of the laparoscopic cholecystectomy,min
Time frame: From enrollment to the end of treatment (3 month)
Acute pancreatitis
Time frame: within 14 days after ERCP
Duration of the Endoscopic retrograde cholangiopancreatography
Time frame: From enrollment to the end of treatment (3 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 10 Mar 2025.
- Individual participant dataSharing planned: Yes. A complete dataset can be provided upon reasoned request
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Not yet recruiting
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RecruitingObservational study
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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.
Dmitriy А Pyhteev, PhD study director
Head of the Department of Pediatric Surgery
Leonid M Elin principal investigator
Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
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 Choledocholithiasis and Cholecystolithiasis, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
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 11 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 10 Mar 2025. 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 Russia. 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?
Recurrence of stones in the common bile duct (time frame: 30 days 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 10 Mar 2025.