Comparing ERCP with and without Gall Bladder Drainage

Randomized Multicentre Double-blind Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage in Non-surgical Patients With Symptomatic Choledocholithiasis

This study is testing if adding gallbladder drainage to a common procedure for bile duct stones can help older patients avoid complications better than just the procedure alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 75 Years and up
• Sex: All
• Sponsor: Hospital del Rio Hortega (other)
• Locations: 1 site (Valladolid)
• Trial ID: NCT03921502 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining endoscopic retrograde cholangiopancreatography (ERCP) with transmural gallbladder drainage in patients over 75 years old who have symptomatic choledocholithiasis and are not candidates for surgery. The study aims to determine if this combined approach reduces the incidence of biliary complications compared to ERCP alone over a one-year follow-up period. It is a multicentric, double-blind, randomized trial involving approximately 150 participants split into two groups. The trial will also assess technical success rates and complications associated with each intervention.

Who should consider this trial

Good fit: Ideal candidates are patients over 75 years old with symptomatic choledocholithiasis who are not eligible for surgical treatment.

Not a fit: Patients with a Charlson comorbidity score adjusted for age of less than 4 or those with other acute conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrent biliary complications in elderly patients who cannot undergo surgery.

How similar studies have performed: While this specific combination of treatments is being tested, similar approaches in managing biliary complications have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* Symptomatic choledocholithiasis (choledocholithiasis demonstrated radiologically or highly suspected by clinical data (acute cholangitis or obstructive jaundice), analytical and imaging according to the criteria of high probability of choledocholithiasis established in the clinical guidelines (ASGE Guide).
* Discarded for surgical treatment due to age, comorbidity or refusal of the patient.
* Age\>75 years

Exclusion Criteria:

* Charlson comorbidity scale adjusted to age \<4.
* Hepatobiliary surgery or previous superior digestive tract.
* Ascitis.
* Inability to tolerate sedation of endoscopy, perforation of the digestive tract or other contraindication to endoscopy.
* Coagulopathy with INR (international normalized ratio) \> 1.5 not correctable or thrombocytopenia \<50000 / mm3 not correctable.
* Other diagnoses at admission (acute cholecystitis, acute pancreatitis, biliopancreatic neoplasia).
* Hemodynamic instability.
* Urgent procedure performed after hours
* No availability of expert material / endoscopist in drainage.
* Anatomical impossibility of performing biliary drainage (absence of vesicular distension, contact between gallbladder and stomach or duodenum, contact area \<10 mm).
* Baseline ECOG (Easthern Cooperative Oncology Group) \> = 4
* Expectancy of survival \<6 months.
* Refusal to participate.
* Distance between the gallbladder and upper digestive tract\> 1cm, scleroatrophic vesicle, lack of stable acoustic window for drainage
* ERCP failed (inhability to dain common bile duct)

Where this trial is running

Valladolid

• Hospital Rio Hortega — Valladolid, Spain (RECRUITING)

Study contacts

• Principal investigator: Ana Y Carbajo López, MD — Hospital Río Hortega
• Study coordinator: Marina de Benito Sanz, MD

Conditions: Bile Duct, Obstruction, With Calculus, Choledocholithiasis, Gall Bladder drainage, LAMS