Gall StoneLERVNCT07008170
Laparoendoscopic Rendezvous for Concomitant Gall Bladder Stones and Common Bile Duct Stones
A study testing Laparoendoscopic rendezvous in people with Gall Stone and Common Bile Duct Calculi, run by Minia University at 1 site in Egypt.
Trial summary
Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gall Stone, Common Bile Duct Calculi, Cholecystitis, Chronic
- What is being tested?
- Laparoendoscopic rendezvous
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having stone(s) in the gallbladder and concurrent common bile duct , as determined by MRCP(magnetic resonance cholangiopancreatography) or US.
- Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for common bile duct stones, such as dilated CBD( common bile duct ) on US examination > 7 mm in diameter without obvious common bile duct stones, high serum bilirubin level, and/or high serum alkaline phosphatase level, were also included in this study. (high risk for cholecystocholedocholithiasis)
- Previous failed ERCP attempt
- Patients fit for general anesthesia and tolerant of pneumoperitoneum and endoscopic procedures.
Who cannot join
- History of hepatobiliary surgery as choledochoduodenal anastomosis
- A Previous upper abdominal surgery as total or partial gastric resection.
- Morbid obesity.
- Uncorrectable coagulopathy.
- Patients who refused to give consent.
- Pregnancy.
Show all 12Show fewer
- Suspected malignant biliary stricture or cholangiocarcinoma
- Severe acute cholangitis with hemodynamic instability or septic shock requiring immediate biliary drainage (may necessitate emergent ERCP or percutaneous drainage first)
- Impacted CBD stones or stones deemed too large for endoscopic extraction (e.g., > 1.5 cm)
- Severe cardiopulmonary disease significantly increasing operative risk.
- Intrahepatic bile duct stones with indications for surgery.
- Patients with choledocholithiasis >2 cm or a large number of stones were difficult to remove.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Liver and GIT hospital , Minia University
Minya, 61519
Saleh K Saleh, MD, 01201765401 ext. +2, salehkhairy@mu.edu.eg
About this study
Official title: Laparoendoscopic Rendezvous for Difficult Cholecystocholedocholithiasis.
Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC( laparoscopic cholecystectomy) after ERCP( endoscopic retrograde cholangiopancreatography).
The aim of this prospective study is to evaluate the efficacy and safety Laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis.
Read the detailed description
The incidence of concomitant choledocholithiasis in patients with gallstone disease has been reported to range between 10% and 20% depending on geographic distribution.The ideal management of cholecysto-choledocholithiasis is still a matter of debate; different modalities, including the open and the laparoscopic approach, and sequential or simultaneous techniques, have been applied with success.
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD( common bile duct) 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 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 Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).
The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification.
Aim of the study is to evaluate use of laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis using preprocedural abdominal CT findings. Primary outcome is to performs difficult biliary cannulation by rendezvous technique while secondary outcomes is to to detect morbidity (especially post-ERCP pancreatitis) , success of CBD clearance and to detect overall hospital
Risk factors of difficult cannulation during ERCP based on preprocedural abdominal CT findings in the study :
- periampullary diverticulum
- Location of the major papilla other than the descending duodenum
- Presence of papilla bulging
- Choledochoduodenal (CD) angle: the angle between the distal common bile duct and adjacent duodenum,
- CBD( common bile duct) diameter
- Far distal CBD (common bile duct) stone B. Laboratory investigation: normal bilirubin C. Previous upper gastrointestinal tract surgery/ Surgically altered anatomy
- Conditions
- Gall Stone, Common Bile Duct Calculi, Cholecystitis, Chronic, Choledocholithiasis, Periampullary Diverticula
- Being tested
- Laparoendoscopic rendezvous
- Medical subject headings
- Gallstones, Cholecystitis, Bronchiolitis Obliterans Syndrome, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoendoscopic rendezvousProcedure or surgery
The main principles of LERV technique consists of
- An antegrade trans cystic cannulation of the bile duct during laparoscopic cholecystectomy, with a guidewire that can be retrieved with a duodenoscope, thus facilitating retrograde bile duct cannulation.
- An over-the-wire sphincterotome is then inserted and standard maneuvers of endoscopic common bile duct stones clearance are performed.
- The procedure is then completed by cholecystectomy in one procedure
| Study group | Role | What they receive |
|---|---|---|
| Laparoendoscopic rendezvous(LERV) | Other | Step 1: Laparoscopic Phase Step 2: Endoscopic Phase Step 3: Completion Receives: Procedure: Laparoendoscopic rendezvous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the success rate of LERV for difficult cannulation
Assess the success rate of LERV for difficult cannulation
Measured: Intraoperative
Secondary outcomes (8)
assess the success rate of LERV in clearing the common bile duct in patients with choledocholithiasis
CBD clearance success,Complete extraction of all stones during LERV judged by ERCP imaging
Measured: intraoperative
incidence of postsphincterotomy bleeding
obvious bleeding during ERCP Or delayed as melena
Measured: 30 days after LERV
incidence of Acute pancreatitis
increase serum amylase and lipase
Measured: 30 days after ERCP
Recurrence of common bile duct stones
The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound.
Measured: 60 days after LERV
Incidence of bile leak
bile aspirated from the abdominal cavity
Measured: 30 days after LERV
incidence of Perforation
by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)
Measured: 30 days after LERV
incidence of Acute cholangitis
intermittent chills, fever, increased proinflammatory blood markers after ERCP
Measured: 60 days after LERV
incidence of bile duct stricture
after LERV
Measured: 1 year after LERV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start15 Jun 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gall StoneStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008170
- Sponsor's protocol ID
- 1379/12/2024
- Acronym
- LERV
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saleh SK, Elsharkawy SS, Hassanen AM. Laparoendoscopic Rendezvous for Difficult Cholecystocholedocholithiasis: A Prospective Cohort Study With Computed Tomography-Based Risk Stratification. World J Surg. 2026 Sep 22. doi: 10.1002/wjs.70575. Online ahead of print.
PubMed 42771446
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoendoscopic Rendezvous for Difficult Cholecystocholedocholithiasis.
- ClinicalTrials.gov ID
- NCT07008170
- Acronym / sponsor ID
- LERV / 1379/12/2024
- Conditions
- Gall Stone, Common Bile Duct Calculi, Cholecystitis, Chronic, Choledocholithiasis, Periampullary Diverticula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 6 Jun 2025 (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 in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC( laparoscopic cholecystectomy) after ERCP( endoscopic retrograde cholangiopancreatography).
The aim of this prospective study is to evaluate the efficacy and safety Laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis.
Detailed description
The incidence of concomitant choledocholithiasis in patients with gallstone disease has been reported to range between 10% and 20% depending on geographic distribution.The ideal management of cholecysto-choledocholithiasis is still a matter of debate; different modalities, including the open and the laparoscopic approach, and sequential or simultaneous techniques, have been applied with success.
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD( common bile duct) 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 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 Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).
The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification.
Aim of the study is to evaluate use of laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis using preprocedural abdominal CT findings. Primary outcome is to performs difficult biliary cannulation by rendezvous technique while secondary outcomes is to to detect morbidity (especially post-ERCP pancreatitis) , success of CBD clearance and to detect overall hospital
Risk factors of difficult cannulation during ERCP based on preprocedural abdominal CT findings in the study :
- periampullary diverticulum
- Location of the major papilla other than the descending duodenum
- Presence of papilla bulging
- Choledochoduodenal (CD) angle: the angle between the distal common bile duct and adjacent duodenum,
- CBD( common bile duct) diameter
- Far distal CBD (common bile duct) stone B. Laboratory investigation: normal bilirubin C. Previous upper gastrointestinal tract surgery/ Surgically altered anatomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoendoscopic rendezvous(LERV) | Other | Procedure: Laparoendoscopic rendezvousStep 1: Laparoscopic Phase Step 2: Endoscopic Phase Step 3: Completion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having stone(s) in the gallbladder and concurrent common bile duct , as determined by MRCP(magnetic resonance cholangiopancreatography) or US.
- Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for common bile duct stones, such as dilated CBD( common bile duct ) on US examination > 7 mm in diameter without obvious common bile duct stones, high serum bilirubin level, and/or high serum alkaline phosphatase level, were also included in this study. (high risk for cholecystocholedocholithiasis)
- Previous failed ERCP attempt
- Patients fit for general anesthesia and tolerant of pneumoperitoneum and endoscopic procedures.
Key exclusion criteria (12 listed)
- History of hepatobiliary surgery as choledochoduodenal anastomosis
- A Previous upper abdominal surgery as total or partial gastric resection.
- Morbid obesity.
- Uncorrectable coagulopathy.
- Patients who refused to give consent.
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 |
|---|---|---|
| Laparoendoscopic rendezvousThe main principles of LERV technique consists of 1. An antegrade trans cystic cannulation of the bile duct during laparoscopic cholecystectomy, with a guidewire that can be retrieved with a duodenoscope, thus facilitating retrograde bile duct cannulation. 2. An over-the-wire sphincterotome is then inserted and standard maneuvers of endoscopic common bile duct stones clearance are performed. 3. The procedure is then completed by cholecystectomy in one procedure | Procedure or surgery | Laparoendoscopic rendezvous(LERV) |
Primary outcome
Assess the success rate of LERV for difficult cannulation
Time frame: Intraoperative
Assess the success rate of LERV for difficult cannulation
8 secondary outcomes
assess the success rate of LERV in clearing the common bile duct in patients with choledocholithiasis
Time frame: intraoperative
incidence of postsphincterotomy bleeding
Time frame: 30 days after LERV
incidence of Acute pancreatitis
Time frame: 30 days after ERCP
Recurrence of common bile duct stones
Time frame: 60 days after LERV
Incidence of bile leak
Time frame: 30 days after LERV
incidence of Perforation
Time frame: 30 days after LERV
incidence of Acute cholangitis
Time frame: 60 days after LERV
incidence of bile duct stricture
Time frame: 1 year after LERV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 42771446Saleh SK, Elsharkawy SS, Hassanen AM. Laparoendoscopic Rendezvous for Difficult Cholecystocholedocholithiasis: A Prospective Cohort Study With Computed Tomography-Based Risk Stratification. World J Surg. 2026 Sep 22. doi: 10.1002/wjs.70575. Online ahead of print.
- 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.
Saleh K Saleh, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoendoscopic rendezvous in people with Gall Stone and Common Bile Duct Calculi, run by Minia 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saleh K Saleh, MD (01201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the success rate of LERV for difficult cannulation (time frame: Intraoperative). 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 NCT07008170, which also lists 1 linked publication.
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 Jun 2025.