Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
Randomized Multicentre Double-blind Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage in Non-surgical Patients With Symptomatic Choledocholithiasis
Hospital del Rio Hortega
150 participants
Aug 1, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria15
- 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)
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Interventions
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)
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NCT03921502