Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorHospital del Rio Hortega
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gall bladder transmural drainage with LAMS
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital del Rio Hortega
Lead sponsor
Hospital Universitario Ramon y Cajal
Collaborator
Hospital General Universitario de Alicante
Collaborator
Source ClinicalTrials.gov