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Compares treatment options for Bile Duct; Obstruction, With Calculus
Official title Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
ClinicalTrials.gov ID: NCT03921502
What this study is testing
- What it's testing
- Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- Symptomatic choledocholithiasis (choledocholithiasis demonstrated radiologically or highly suspected by clinical data (acute cholangitis or...
- Discarded for surgical treatment due to age, comorbidity or refusal of the patient.
- Age\>75 years
You likely can't join if
- 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).
See the full eligibility 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...
- Discarded for surgical treatment due to age, comorbidity or refusal of the patient.
- Age\>75 years
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Valladolid, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valladolid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.