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Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
Sponsor: Hospital del Rio Hortega
Summary
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.
Official title: Randomized Multicentre Double-blind Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage in Non-surgical Patients With Symptomatic Choledocholithiasis
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2019-08-01
Completion Date
2026-05-01
Last Updated
2025-03-11
Healthy Volunteers
No
Interventions
Gall bladder transmural drainage with LAMS
Placing a PAL Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL 15x10 mm or 10x10 mm will be \*placed on it to generate the anastomosis between the aforementioned structures.
Locations (1)
Hospital Rio Hortega
Valladolid, Spain