Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage

Launched by HOSPITAL DEL RIO HORTEGA · Apr 17, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with a condition called choledocholithiasis, which means they have gallstones obstructing their bile duct and are experiencing symptoms. The researchers want to find out if a combination of two procedures—endoscopic retrograde cholangiopancreatography (ERCP) and a method to drain the gallbladder through the stomach wall—can help reduce health problems related to this condition compared to using ERCP alone. The trial will follow participants for one year to see which method works better and to check for any complications.

To be eligible for the trial, participants must be over 75 years old and have symptoms of choledocholithiasis that cannot be treated with surgery for various reasons, such as age or health conditions. Participants can expect to be randomly assigned to one of two treatment groups and may undergo one of the two procedures. The trial aims to include around 150 patients, and it's currently looking for participants. This study could provide important information on how to better manage gallstone-related issues in older patients.

Gender

ALL

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)