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RecruitingNCT06311305Updated Mar 15, 2024

Does Early Laparoscopic Cholecystectomy After ERCP Reduce the Risk of Complications

An interventional study of Early Laparoscopic cholecystectomy in Cholelithiases, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
15 Years to 70 Years
Sex
All
01

Study summary

Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985.

The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.

Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria.

Read the detailed description

Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985. 1 The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.2 Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria.3 The diagnosis of choledocholithiasis is initially suggested by symptomatology, laboratory tests, and ultrasound (US) findings. Abdominal ultrasound being the most commonly used initial diagnostic tool for suspected biliary stones has a sensitivity of 25-60% and specificity of 95-100%.4 Ultrasound can reliably detect a dilated extrahepatic bile duct, typically a CBD > 6 mm. However, a large study of patients undergoing cholecystectomy found that nearly half of the patients with choledocholithiasis have a nondilated CBD.5 Moreover, the diameter of the extrahepatic bile duct increases with age and older patients may have a normal duct greater than 6 mm. Largely, due to its poor sensitivity, a negative US does not rule out choledocholithiasis. Contrast enhanced computed tomography has a sensitivity of 71-85% and specificity of 88-95% which can further be improved by addition of a hepatobiliary-excreted intravenous contrast agent.6,7 Since the introduction in 1991, Magnetic resonance cholangiopancreatography (MRCP) has emerged as an accurate, non-invasive diagnostic modality for investigating the biliary and pancreatic ducts with sensitivity of 90-100% and specificity of 92-100%.8,9 An impacted biliary stone will appear as a filling defect with a crescent of bile.10 In 1968, ERCP was introduced as a diagnostic tool in the management of biliary and pancreatic diseases.11 With introduction of Endoscopic sphincterotomy, ERCP has now developed as a therapeutic tool with sensitivity of 90% and specificity of 98%.12 ERCP stone extraction is successful 80% - 90% of time using the techniques of sphincterotomy and balloon catheter or Dormia basket stone retrieval.13 Pancreatitis is the most common complication seen after ERCP. ERCP- induced pancreatitis is defined as new or worsened abdominal pain with serum amylase that is greater than three times the upper limit of normal at 24 hours post procedure and requires at least two days of hospitalisation. Although transient elevation of pancreatic enzymes i.e. serum amylase and serum lipase are evident after ERCP.14 Long term complications include papillary stenosis, cholangitis and recurrent choledocholithiasis.15 The introduction of Laparoscopic cholecystectomy has significantly influenced the treatment of patients with gallstones. Currently it is estimated that over 80% of cholecystectomies are performed using the laparoscopic approach. Advantages of laparoscopic cholecystectomy include earlier bowel function, less postoperative pain, improved cosmesis, shorter length of hospital stay, earlier return to full activity and decreased overall cost. Laparoscopic cholecystectomy (LC) preceded by preoperative ERCP remains the cornerstone and most commonly practiced strategy worldwide for the management of coexisting gallbladder and CBD stones.16 According to the literature, the conversion rate for laparoscopic cholecystectomy (LC) after endoscopic sphincterotomy (ES) for choledocholithiasis reaches 20%, when laparoscopic cholecystectomy is performed 6 to 8 weeks afterward3. Also, many Patients waiting to undergo cholecystectomy after ES for CBD stones, experiences recurrent biliary events requiring repeated endoscopic reintervention, emergency cholecystectomy or both which not only have an obvious influence on a patient's well-being, but also appear to be associated with increased difficulty of surgery and a more complicated postoperative course.17.

Cholecystectomy is often performed after ERCP (endoscopic retrograde cholangiopancreatography) for patients with gallstones in the common bile duct. However, cholecystectomy after ERCP may have some risks and complications, such as:

  • Longer operative time and increased bleeding
  • Higher conversion rate to open cholecystectomy
  • Difficulty in achieving the critical view of safety
  • More post-operative drain and longer hospital stay
  • Infection, perforation, pancreatitis, or bile leak. 17.18 Post ERCP cholecystectomy assessment of difficulty is important to reduce the complications , conversion rate , choose of surgery team ,schedule surgery and improve outcomes .There are multiple risk factor associated with post ERCP cholecystectomyhave beenpreviously described in the literature such as age , sex , obesity anatomical variation ,previous surgery , impacted stone etc .Intra operatively, it has been observed that surgeons encountered difficulty while LC post ERCP when there were dense adhesions at calot's triangle, fibrotic and contracted gallbladder,acutely inflamed or cholecysto-enteric fistula etc.19 The risk of complications may depend on several factors, such as the timing of cholecystectomy after ERCP, the presence of a stent in the bile duct, the severity of gallstone disease, and the experience of the surgeon¹²⁴. Therefore, it is important to discuss the benefits and risks of cholecystectomy after ERCP .20
02

Conditions studied

  • Cholelithiases

Keywords

  • ERCP
  • Laparoscopic
  • cholecystectomy
  • Gallstones
03

In context

Cholelithiasis

189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 135 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients post ERCP with gall stone.
  • Age 15-70
  • Gender female and male patient.

Exclusion criteria

Exclusion Criteria:

  • Post ERCP pancreatitis
  • Septicemia
  • Hepatocellular jaundice and End stage liver disease
  • Patient who didn't give .
  • Patients who refused laparoscopic cholecystectomy.
  • Patients who were not fit for general anesthesia due to various medical illnesses.
  • ERCP for reasons other than stone disease,
  • to Laparoscopic cholecystectomy like: Cardiovascular andpulmonary disease, coagulopathies and end-stage liver disease (ESLD).
  • Patients with Carcinoma Gall bladder, Common bile duct strictures, Coagulopathy, previous upper abdominal surgeries
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    early laparoscopic cholecystectomy after ERCP

    we assess the risks and complications of early laparoscopic cholecystectomy after ERCP

    Procedure: Early Laparoscopic cholecystectomy

Interventions

  • ProcedureEarly Laparoscopic cholecystectomy

    laparoscopic cholecystectomy early after ERCP with assessing the risks and complications

    Also known as: laparoscopic cholecystectomy

06

What researchers measure

Primary outcomes

  1. bile leakage

    yes or no

    Time frame: 2 weeks postoperative

  2. operative time

    in hours

    Time frame: intraoperative

  3. intraoperative bleeding

    in cubic centimeters

    Time frame: intraoperative

  4. sepsis

    yes or no

    Time frame: 2 weeks postoperative

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06311305
Lead sponsor
Sohag University
Responsible party
Abdulla Mohammed Ahmed (Abdulla Mohammed Ahmed Hussein, Sohag University) — Principal investigator
First posted
Mar 15, 2024
Start date
Mar 1, 2024
Primary completion
Aug 1, 2024 (estimated)
Completion
Aug 20, 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Abdulla M Ahmed, Master
Contact
abdallah_mohamed_ex@med.sohag.edu.eg
01099696698 ext. 002
Abdulla M Ahmed, Master
Contact
farragmostafa50@gmail.com
01099696698 ext. 002

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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