Calculus; Gallbladder, With CholecystitisNCT05734144
Two Institutes Experience in Laparo-Endoscopic Rendezvous Technique for Gallbladder and Bile Duct Stones
A study testing The intraoperative ERCP has been performed immediately before LC and POES followed by LC in people with Calculus; Gallbladder, With Cholecystitis, run by Zagazig University.
Trial summary
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD stones has evolved considerably since the advent of laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Calculus; Gallbladder, With Cholecystitis
- What is being tested?
- The intraoperative ERCP has been performed immediately before LC and POES followed by LC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients having stone in the gallbladder and concurrent CBD stone, as determined by MRCP or US.
- Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for CBD, stones such as dilated CBD on US examination more than7 mm in diameter without obvious CBD stones, high serum bilirubin level, and or high serum alkaline phosphatase level, were also included in this study.
Who cannot join
- Patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis.
- Patients with previous ERCP attempt.
- Patients with previous upper abdominal surgery as total or partial gastric resection.
- Patients with morbid obesity.
- Patients with uncorrectable coagulopathy.
- Patients aged below 18 years or above 80 years.
- Patients within the American Society of Anesthesiology (ASA) class 4 and 5 disease.
- Patients who refused to give consent or participate in the study.
About this study
Official title: Two Institutes Experience In Laparo-Endoscopic Rendezvous Technique For Patients Undergoing Laparscopic Cholecystectomy For Stones In The Gallbladder And Bile Duct; A Prospective Randomized Comparative Clinical Trial
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD stones has evolved considerably since the advent of laparoscopic surgery. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. So the aim of this study was was to evaluate one-stage LC with intra-operative endoscopic sphincterotomy (IOES) vs two-stage pre-operative endoscopic sphincterotomy (POES) followed by LC for the treatment of cholecystocholedocholithiasis.
Read the detailed description
This is two center study was carried out on 523 patients and completed in 436 patients with gall bladder stones and with suspected or confirmed CBDS at two gastroenterology center at zagazig first 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and second 172 patients at gastroenterology unite at AL AHRAR hospital from January 2010 till April 2022. A single-step technique combining LC and IO-ERCP was used to treat them. To confirm the presence of CBDS, a laparoscopic intraoperative cholangiography (IOC) was performed. A soft-tipped guidewire was inserted into the duodenum through the cystic duct and papilla. Over the guide-wire, an endoscopic papillotomy was introduced. The stones were retrieved with a retrieval balloon after an IO-ERCP and endoscopic sphincterotomy. The length of the postoperative hospital stay, surgical operating time, surgical success rate, postoperative complications, and residual CBDS were all evaluated. 77 patients excluded either incomplete data or didn't complete both steps within our centers.
- Being tested
- The intraoperative ERCP has been performed immediately before LC, POES followed by LC
- Medical subject headings
- Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intraoperative ERCP has been performed immediately before LCProcedure or surgery
combination approach has been used to improve patient compliance and shorten hospital stays. The intraoperative ERCP has been performed immediately before Laparoscopic Cholecystectomy
POES followed by LCProcedure or surgery
Treatment in two stages, which combines a preoperative ES followed by LC (sequential treatment).
| Study group | Role | What they receive |
|---|---|---|
| Laparo-endoscopic "rendezvous" technique | Active comparator | the first group was treated by a single-step procedure combining LC and IOES Receives: Procedure: The intraoperative ERCP has been performed immediately before LC |
| POES followed by LC | Other | the second (control) group was treated by 2-stage (sequential treatment) POES followed by LC. Receives: Procedure: POES followed by LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful stone clearance from the CBD
To ensure that the bile duct was completely clear, a check cholangiogram was conducted.
Measured: first year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study startJan 2010
- Primary completionApr 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculus; Gallbladder, With 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was carried out on 432 patients with gall bladder stones and with suspected or confirmed CBDS at two centers 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and 168 patients at gastroenterology surgery unite at ALAHRAR hospitals from January 2010 till May 2022. Patients were randomized divided into two equally groups, the first group was treated by a single-step procedure combining LC and IOES while the second (control) group was treated by 2-stage (sequential treatment) POES followed by LC.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed I Farid, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734144
- Sponsor's protocol ID
- 10129/20-11-2022
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Institutes Experience In Laparo-Endoscopic Rendezvous Technique For Patients Undergoing Laparscopic Cholecystectomy For Stones In The Gallbladder And Bile Duct; A Prospective Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT05734144
- Acronym / sponsor ID
- 10129/20-11-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2010 (actual)
- Primary completion
- Apr 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 17 Feb 2023 (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.
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD stones has evolved considerably since the advent of laparoscopic surgery. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. So the aim of this study was was to evaluate one-stage LC with intra-operative endoscopic sphincterotomy (IOES) vs two-stage pre-operative endoscopic sphincterotomy (POES) followed by LC for the treatment of cholecystocholedocholithiasis.
Detailed description
This is two center study was carried out on 523 patients and completed in 436 patients with gall bladder stones and with suspected or confirmed CBDS at two gastroenterology center at zagazig first 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and second 172 patients at gastroenterology unite at AL AHRAR hospital from January 2010 till April 2022. A single-step technique combining LC and IO-ERCP was used to treat them. To confirm the presence of CBDS, a laparoscopic intraoperative cholangiography (IOC) was performed. A soft-tipped guidewire was inserted into the duodenum through the cystic duct and papilla. Over the guide-wire, an endoscopic papillotomy was introduced. The stones were retrieved with a retrieval balloon after an IO-ERCP and endoscopic sphincterotomy. The length of the postoperative hospital stay, surgical operating time, surgical success rate, postoperative complications, and residual CBDS were all evaluated. 77 patients excluded either incomplete data or didn't complete both steps within our centers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study was carried out on 432 patients with gall bladder stones and with suspected or confirmed CBDS at two centers 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and 168 patients at gastroenterology surgery unite at ALAHRAR hospitals from January 2010 till May 2022. Patients were randomized divided into two equally groups, the first group was treated by a single-step procedure combining LC and IOES while the second (control) group was treated by 2-stage (sequential treatment) POES followed by LC.
| Arm | Type | Receives |
|---|---|---|
| Laparo-endoscopic "rendezvous" technique | Active comparator | Procedure: The intraoperative ERCP has been performed immediately before LCthe first group was treated by a single-step procedure combining LC and IOES |
| POES followed by LC | Other | Procedure: POES followed by LCthe second (control) group was treated by 2-stage (sequential treatment) POES followed by LC. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients having stone in the gallbladder and concurrent CBD stone, as determined by MRCP or US.
- Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for CBD, stones such as dilated CBD on US examination more than7 mm in diameter without obvious CBD stones, high serum bilirubin level, and or high serum alkaline phosphatase level, were also included in this study.
Key exclusion criteria (8 listed)
- Patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis.
- Patients with previous ERCP attempt.
- Patients with previous upper abdominal surgery as total or partial gastric resection.
- Patients with morbid obesity.
- Patients with uncorrectable coagulopathy.
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 |
|---|---|---|
| The intraoperative ERCP has been performed immediately before LCcombination approach has been used to improve patient compliance and shorten hospital stays. The intraoperative ERCP has been performed immediately before Laparoscopic Cholecystectomy | Procedure or surgery | Laparo-endoscopic "rendezvous" technique |
| POES followed by LCTreatment in two stages, which combines a preoperative ES followed by LC (sequential treatment). | Procedure or surgery | POES followed by LC |
Primary outcome
successful stone clearance from the CBD
Time frame: first year postoperatively
To ensure that the bile duct was completely clear, a check cholangiogram was conducted.
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 17 Feb 2023.
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.
Questions about this trial
What is this clinical trial studying?
A study testing The intraoperative ERCP has been performed immediately before LC and POES followed by LC in people with Calculus; Gallbladder, With Cholecystitis, run by Zagazig University.
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 2 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 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
successful stone clearance from the CBD (time frame: first year postoperatively). 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 17 Feb 2023; AzTrials last refreshed its copy on 29 Oct 2026.