Actively Recruiting
Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
Led by Hospital del Rio Hortega · Updated on 2025-03-11
150
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
Sponsors
H
Hospital del Rio Hortega
Lead Sponsor
H
Hospital Universitario Ramon y Cajal
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms. In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence. The investigators propose a multicentric double-blind randomized trial. Our primary objective is to assess whether ERCP associated with transmural gallbladder drainage is able to reduce biliary disease income compared with ERCP in patients not candidates for surgery with symptomatic choledocholithiasis and cholelithiasis during one year of follow-up. Also the investigators will analyze the proportion of technical success and complications. The study population includes all patients older than 75 years with symptomatic choledocholithiasis. An estimated 75 subjects per group (ERCP alone and ERCP and transmural drainage) are needed.
CONDITIONS
Official Title
Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic choledocholithiasis confirmed by imaging or clinical signs such as acute cholangitis or obstructive jaundice
- Not eligible for surgery due to age, other health conditions, or patient refusal
- Age over 75 years
You will not qualify if you...
- Charlson comorbidity score adjusted for age less than 4
- Previous hepatobiliary or upper digestive tract surgery
- Presence of ascites
- Unable to tolerate sedation or have contraindications to endoscopy
- Coagulopathy with INR over 1.5 not correctable or low platelets below 50,000/mm3 not correctable
- Other diagnoses at admission like acute cholecystitis, pancreatitis, or biliopancreatic tumors
- Hemodynamic instability
- Urgent procedures performed outside regular hours
- Lack of expert materials or endoscopists for drainage
- Anatomical issues preventing biliary drainage such as no gallbladder distension or insufficient contact area with stomach or duodenum
- Baseline Eastern Cooperative Oncology Group (ECOG) score 4 or higher
- Expected survival less than 6 months
- Refusal to participate
- Distance between gallbladder and upper digestive tract greater than 1 cm, scleroatrophic gallbladder, or poor acoustic window for drainage
- Failed ERCP with inability to drain the common bile duct
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Rio Hortega
Valladolid, Spain, 47012
Actively Recruiting
Research Team
M
Marina de Benito Sanz, MD
CONTACT
M
Manuel Pérez-Miranda Castillo, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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