Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage (PECAS)
Bile Duct; Obstruction, With Calculus, Choledocholithiasis
About this trial
This is an interventional treatment trial for Bile Duct; Obstruction, With Calculus focused on measuring Choledocholithiasis, Gall Bladder drainage, LAMS
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- Hospital Rio HortegaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ERCP with sphincterotomy + gall bladder drainage with LAMS
ERCP with sphincterotomy
An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist. After this, transmural drainage of the gallbladder will be performed by placing a LAMS 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 will be placed on it to generate the anastomosis between the aforementioned structures.
An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist.