Testing for bile duct stones before gallbladder surgery

The Sunflower Study: A randomised controlled trial to establish the clinical and cost effectiveness of expectant management versus pre-operative imaging with MRCP in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10378861

Enrollment

7457

Registered

2018-10-02

Start date

2018-12-01

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic gallbladder disease, requiring gallbladder surgery Surgery Symptomatic gallbladder disease, requiring cholecystectomy

Interventions

Participants will be randomly allocated in a 1:2 ratio to receive either a reoperative magnetic resonance pancreaticogram (magentic resonance cholangiopancreatography - MRCP) or no MRCP (expectant man

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure: Any of the following: 1. Any hospital admission within 18 months of randomisation for treatment of complications of gallstones whether in the CBD or gallbladder 2. Complications during the admission for LC for the treatment for gallstones or any readmission for complications of the LC leading to a hospital stay of >2 days. Complications will include, but not be limited to: 2.1. Return to theatre post LC for any cause 2.2. Percutaneous radiological drainage 2.3. ERCP for non-diagnostic reasons (e.g. for a bile leak). It does not include a diagnostic ERCP performed following an MRCP where CBD stones were identified. 3. Complications during any ERCP for the treatment for gallstones. Complications will include: 3.1. Blood transfusion post ERCP 3.2. Percutaneous radiological drainage 3.3. Treatment of a perforation occurring during ERCP 3.4. Acute pancreatitis 3.5. Other complications leading to a hospital stay of >2 days This will be acquired from routine data sources, such as HES data from NHS Digital in England. The HES data will be reviewed and specific OPCS-4 and ICD-10 codes will be searched for. These codes identify specific diagnoses, procedures, etc which will form the primary outcome measure. This will be measured in the 18 months following randomisation. Previous primary outcome measure: Any of the following: 1. Any hospital admission within 18 months of randomisation for treatment of complications of gallstones whether in the CBD or gallbladder 2. Complications during the admission for LC for the treatment for gallstones or readmission for complications of the LC. Complications comprise: 2.1. Return to theatre post LC for any cause 2.2. Percutaneous radiological drainage 2.3. ERC 3. Complications during the index admission for ERCP for the treatment for gallstones (i.e. an ERCP performed following an MRCP where CBD stones were identified). Complications comprise: 3.1. Blood transfusion post ERCP 3.2. Percutaneous radiological	—

Measure

Time frame

Current primary outcome measure: Any of the following: 1. Any hospital admission within 18 months of randomisation for treatment of complications of gallstones whether in the CBD or gallbladder 2. Complications during the admission for LC for the treatment for gallstones or any readmission for complications of the LC leading to a hospital stay of >2 days. Complications will include, but not be limited to: 2.1. Return to theatre post LC for any cause 2.2. Percutaneous radiological drainage 2.3. ERCP for non-diagnostic reasons (e.g. for a bile leak). It does not include a diagnostic ERCP performed following an MRCP where CBD stones were identified. 3. Complications during any ERCP for the treatment for gallstones. Complications will include: 3.1. Blood transfusion post ERCP 3.2. Percutaneous radiological drainage 3.3. Treatment of a perforation occurring during ERCP 3.4. Acute pancreatitis 3.5. Other complications leading to a hospital stay of >2 days This will be acquired from routine data sources, such as HES data from NHS Digital in England. The HES data will be reviewed and specific OPCS-4 and ICD-10 codes will be searched for. These codes identify specific diagnoses, procedures, etc which will form the primary outcome measure. This will be measured in the 18 months following randomisation. Previous primary outcome measure: Any of the following: 1. Any hospital admission within 18 months of randomisation for treatment of complications of gallstones whether in the CBD or gallbladder 2. Complications during the admission for LC for the treatment for gallstones or readmission for complications of the LC. Complications comprise: 2.1. Return to theatre post LC for any cause 2.2. Percutaneous radiological drainage 2.3. ERC 3. Complications during the index admission for ERCP for the treatment for gallstones (i.e. an ERCP performed following an MRCP where CBD stones were identified). Complications comprise: 3.1. Blood transfusion post ERCP 3.2. Percutaneous radiological

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Secondary

Measure	Time frame
1. Health-related quality of life, assessed using the EQ-5D-5L questionnaire at time of randomisation, admission for LC and 3, 6, 12 and 18 months after randomisation (participants will not be asked to complete the admission for LC questionnaire if they have completed their baseline questionnaire within the previous two days) 2. Items in the LC core outcome set, which is due to be published at the end of 2018 3. NHS resource use to 18 months post randomisation, taken from routine data sources such as HES data from NHS Digital in England	—

Measure

Time frame

1. Health-related quality of life, assessed using the EQ-5D-5L questionnaire at time of randomisation, admission for LC and 3, 6, 12 and 18 months after randomisation (participants will not be asked to complete the admission for LC questionnaire if they have completed their baseline questionnaire within the previous two days) 2. Items in the LC core outcome set, which is due to be published at the end of 2018 3. NHS resource use to 18 months post randomisation, taken from routine data sources such as HES data from NHS Digital in England

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Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactStephen Palmer

sunflower-study@bristol.ac.uk+44 (0)7929 771395

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026