Comparing ERCP with and without Gall Bladder Drainage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mbenitosa@saludcastillayleon.es
• Phone: 983420400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.