NCT03921502 Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
| NCT ID | NCT03921502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital del Rio Hortega |
| Condition | Bile Duct; Obstruction, With Calculus |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-08-01 |
| Primary Completion | 2022-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2019-08-01 with a primary completion date of 2022-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Ana Y Carbajo López, MD
PRINCIPAL INVESTIGATOR
Hospital Río Hortega
Frequently Asked Questions
Who can join the NCT03921502 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Bile Duct; Obstruction, With Calculus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03921502 currently recruiting?
Yes, NCT03921502 is actively recruiting participants. Contact the research team at mbenitosa@saludcastillayleon.es for enrollment information.
Where is the NCT03921502 trial being conducted?
This trial is being conducted at Valladolid, Spain.
Who is sponsoring the NCT03921502 clinical trial?
NCT03921502 is sponsored by Hospital del Rio Hortega. The principal investigator is Ana Y Carbajo López, MD at Hospital Río Hortega. The trial plans to enroll 150 participants.