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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Gall bladder transmural drainage with LAMS
Procedure/SurgeryPlacing 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: ERCP with sphincterotomy + gall bladder drainage with LAMSExperimental treatment 1 intervention
Group B: ERCP with sphincterotomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of paticipants readmitted due to biliary pathology
Rate of participants readmitted due to biliary pathology (cholecystitis, cholangitis, pancreatitis, hepatic abscess...) in each group
Time frame
1 yearSecondary outcomes
1
Number of participants with technical success
Number of participants with correct placement of the stent from the gastric or duodenal lumen to the gallbladder, together with the documentation of bile flow and / or contrast through it.
Time frame
1 day2
Number of dead participants
Rate of deaths in each group
Time frame
1 year3
Hospital costs (euros)
Hospital costs (euros) during the period of follow up, including the baseline admission
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital del Rio Hortega
Lead sponsor
Hospital Universitario Ramon y Cajal
Collaborator
Hospital General Universitario de Alicante
Collaborator
Source ClinicalTrials.gov