Choledocholithiasis With CholecystitisNCT06340594
Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?
An observational study of Choledocholithiasis With Cholecystitis and Biliary Stones, run by Assiut University at 1 site in Egypt.
Trial summary
Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Choledocholithiasis With Cholecystitis, Biliary Stones
- What is being tested?
- Laproscopic cholecystectomy (LC) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Jan 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with chronic calculous cholecystitis associated with common bile duct (CBD) stones admitted in a tertiary care hospital
Who may be able to join
- Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis
Who cannot join
- Contraindications to ERCP, or laparoscopic surgery
- Cholangitis and pancreatitis
- Previously failed ERCP
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine-Assiut University -Assiut-Egypt
Asyut, Asyut Governorate, 71515
About this study
Official title: Single-stage Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?
Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches.
- Being tested
- Laproscopic cholecystectomy (LC), Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Keywords
- Choledocholithiasis, ERCP, Laparoscopic cholecystectomy, Cholecystocholedocholithiasis
- Medical subject headings
- Cholecystolithiasis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laproscopic cholecystectomy (LC)Procedure or surgery
Removal of gallbladder via laparoscopy
Endoscopic Retrograde Cholangiopancreatography (ERCP)Procedure or surgery
Removal of bile duct stones via endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group A (ERCP 1st approach) | The patients first underwent ERCP followed by standard 4 port LC. Receives: Procedure: Laproscopic cholecystectomy (LC); Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP) | |
| Group B (LC 1st approach) | The patients first underwent LC followed by ERCP. Receives: Procedure: Laproscopic cholecystectomy (LC); Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time operative time
total operative time of both ERCP+LC
Measured: time in minutes from intubation of the patient to the end of procedure
Secondary outcomes (3)
CBD clearance rate
success rate of retrieval of stones
Measured: up to 2 years
Length of hospital stay
days of hospital stay
Measured: up to 2 weeks post-operative
Mortality rate
number of deaths intraoperative and postoperative related to surgery
Measured: up to 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jan 2021
- Primary completion1 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Choledocholithiasis With CholecystitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Raafat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340594
- Sponsor's protocol ID
- RF-2-2024
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226.
PubMed 20083751Muhammedoglu B, Kale IT. Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial. Int J Surg. 2020 Apr;76:37-44. doi: 10.1016/j.ijsu.2020.02.021. Epub 2020 Feb 24.
PubMed 32105889Elgeidie A, Atif E, Elebidy G. Intraoperative ERCP for management of cholecystocholedocholithiasis. Surg Endosc. 2017 Feb;31(2):809-816. doi: 10.1007/s00464-016-5036-1. Epub 2016 Jun 22.
PubMed 27334962Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M; British Society of Gastroenterology. Guidelines on the management of common bile duct stones (CBDS). Gut. 2008 Jul;57(7):1004-21. doi: 10.1136/gut.2007.121657. Epub 2008 Mar 5.
PubMed 18321943Nie S, Fu S, Fang K. Comparison of one-stage treatment versus two-stage treatment for the management of patients with common bile duct stones: A meta-analysis. Front Surg. 2023 Feb 3;10:1124955. doi: 10.3389/fsurg.2023.1124955. eCollection 2023.
PubMed 36816010
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-stage Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?
- ClinicalTrials.gov ID
- NCT06340594
- Acronym / sponsor ID
- RF-2-2024
- Keywords
- Choledocholithiasis, ERCP, Laparoscopic cholecystectomy, Cholecystocholedocholithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 Apr 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.
Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (ERCP 1st approach) | – | Procedure: Laproscopic cholecystectomy (LC), Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)The patients first underwent ERCP followed by standard 4 port LC. |
| Group B (LC 1st approach) | – | Procedure: Laproscopic cholecystectomy (LC), Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)The patients first underwent LC followed by ERCP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic calculous cholecystitis associated with common bile duct (CBD) stones admitted in a tertiary care hospital
Key inclusion criteria (1 listed)
- Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis
Key exclusion criteria (3 listed)
- Contraindications to ERCP, or laparoscopic surgery
- Cholangitis and pancreatitis
- Previously failed 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 |
|---|---|---|
| Laproscopic cholecystectomy (LC)Removal of gallbladder via laparoscopy | Procedure or surgery | Group A (ERCP 1st approach), Group B (LC 1st approach) |
| Endoscopic Retrograde Cholangiopancreatography (ERCP)Removal of bile duct stones via endoscopy | Procedure or surgery | Group A (ERCP 1st approach), Group B (LC 1st approach) |
Primary outcome
Operative time operative time
Time frame: time in minutes from intubation of the patient to the end of procedure
total operative time of both ERCP+LC
3 secondary outcomes
CBD clearance rate
Time frame: up to 2 years
Length of hospital stay
Time frame: up to 2 weeks post-operative
Mortality rate
Time frame: up to 1 month postoperative
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 2 Apr 2024.
- Background: PubMed 20083751Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226.
- Background: PubMed 32105889Muhammedoglu B, Kale IT. Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial. Int J Surg. 2020 Apr;76:37-44. doi: 10.1016/j.ijsu.2020.02.021. Epub 2020 Feb 24.
- Background: PubMed 27334962Elgeidie A, Atif E, Elebidy G. Intraoperative ERCP for management of cholecystocholedocholithiasis. Surg Endosc. 2017 Feb;31(2):809-816. doi: 10.1007/s00464-016-5036-1. Epub 2016 Jun 22.
- Background: PubMed 18321943Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M; British Society of Gastroenterology. Guidelines on the management of common bile duct stones (CBDS). Gut. 2008 Jul;57(7):1004-21. doi: 10.1136/gut.2007.121657. Epub 2008 Mar 5.
- Background: PubMed 36816010Nie S, Fu S, Fang K. Comparison of one-stage treatment versus two-stage treatment for the management of patients with common bile duct stones: A meta-analysis. Front Surg. 2023 Feb 3;10:1124955. doi: 10.3389/fsurg.2023.1124955. eCollection 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 With Cholecystitis and Biliary Stones, run by Assiut University at 1 site in Egypt.
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 3 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 2 Apr 2024. 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 Egypt. 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?
Operative time operative time (time frame: time in minutes from intubation of the patient to the end of procedure). 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 NCT06340594, which also lists 5 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 2 Apr 2024.