Testing for bile duct stones before gallbladder surgery
- Conditions
- Symptomatic gallbladder disease, requiring gallbladder surgerySurgerySymptomatic gallbladder disease, requiring cholecystectomy
- Registration Number
- ISRCTN10378861
- Lead Sponsor
- eeds Teaching Hospitals NHS Trust
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34187817/ (added 13/08/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 7457
Current inclusion criteria as of 15/01/2020:
1. Aged 18 years or older
2. Symptomatic gallbladder disease, confirmed by trans-abdominal ultrasound scan (USS) or computed tomography (CT) scan, including, for example:
2.1. Biliary colic
2.2. Cholecystitis
2.3. Mild and severe gallstone pancreatitis
2.4. Gallbladder polyps
2.5. Gallbladder dyskinesia, etc
3. Scheduled and fit for laparoscopic cholecystectomy (LC) as an elective or urgent procedure
4. Low or moderate risk of common bile duct (CBD) stones, including all of the following:
4.1. CBD diameter =8 mm on USS
4.2. Bilirubin = 50umol/l
4.3. Alanine transferase less than three times the upper limit of normal (=3 x ULN) and/or alkaline phosphatase =3 x ULN
If a patient does not meet the definition of low or moderate risk of CBD stones solely because both alanine transferase and alkaline phosphatase are > 3 x ULN, if repeat blood tests are carried out and at least one of the second or subsequent test results is within range (i.e. = 3 x ULN) the patient may be recruited at that time.
If a patient does not meet the definition of low or moderate risk of CBD stones solely because bilirubin > 50umol/l, if repeat blood tests are carried out and at least one of the second or subsequent test results is within range the patient may be recruited at that time.
If CBD cannot be seen on USS or CT scan, the patient may be recruited as long as all the other inclusion criteria are met and there is no intrahepatic duct dilatation reported.
Previous inclusion criteria:
1. Aged 18 years or older
2. Symptomatic gallstone disease, confirmed by trans-abdominal ultrasound scan (USS) or computed tomography (CT) scan, including:
2.1. Biliary colic
2.2. Cholecystitis
2.3. Mild and severe pancreatitis
2.4. Gallbladder polyps
2.5. Gallbladder dyskinesia
3. Scheduled and fit for laparascopic cholecystectomy (LC) as an elective or urgent procedure
4. Low or moderate risk of common bile duct (CBD) stones, including all of the following:
4.1. CBD diameter =8 mm on USS
4.2. Bilirubin = 50umol/l
4.3. Alanine transferase less than twice the upper limit of normal (=2 x ULN) and/or alkaline phosphatase =2 x ULN.
If a patient does not meet the definition of low or moderate risk of CBD stones solely because both alanine transferase and alkaline phosphatase are > 2 x ULN, if repeat blood tests are carried out and at least one of the second or subsequent test results is within range (i.e. = 2 x ULN) the patient may be recruited at that time.
If a patient does not meet the definition of low or moderate risk of CBD stones solely because bilirubin > 50umol/l, if repeat blood tests are carried out and at least one of the second or subsequent test results is within range the patient may be recruited at that time.
If CBD cannot be seen on USS or CT scan, the patient may be recruited as long as all the other inclusion criteria are met and there is no intrahepatic duct dilatation reported.
Current exclusion criteria as of 15/01/2020:
1. Unable to undergo MRCP
2. Evidence of empyema or perforated gallbladder requiring urgent intervention
3. Previous gastric bypass
4. Previous MRCP or endoscopic ultrasound (EUS) within last 3 months
5. Any previous ERCP
6. Haemolytic disease
7. Pregnancy
8. Unwilling to participate in follow up
9. Unable to provide written informed consent
10. Prisoner
Previous exclusion criteria:
1. Unable to undergo MRCP
2. Evidence of empyema or perforated gallbladder requiring urgent intervention
3. Previous duodenal bypass
4. Previous MRCP within last 3 months
5. Haemolytic disease
6. Pregnancy
7. Unwilling to participate in follow up
8. Unable to provide written informed consent
9. Prisoner
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method