Cost effectiveness, safety and efficiency of using a cannulatome versus a cannula for initial cannulation at endoscopic retro-grade cholangiopancreatography (ERCP) in suspected choledocolithiasis
| ISRCTN | ISRCTN54340540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54340540 |
| Protocol serial number | N0199129927 |
| Sponsor | Department of Health |
| Funder | Royal Berkshire and Battle Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A S Mee
Scientific
Scientific
Gastroenterology Department
Royal Berkshire & Battle Hospitals NHS Trust
London Road
Reading
RG1 5AN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Cost effectiveness, safety and efficiency of using a cannulatome versus a cannula for initial cannulation at endoscopic retro-grade cholangiopancreatography (ERCP) in suspected choledocolithiasis |
| Study objectives | Is the initial use of a cannulatome more cost effective than the initial use of a diagnostic cannula in patients with suspected choledocolithiasis? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Choledocholithiasis |
| Intervention | Cannulatome vs diagnostic cannula |
| Intervention type | Other |
| Primary outcome measure(s) |
Success of cannulation, time to cannulation and sphincterotomy and complication rates |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 27/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key inclusion criteria | 50 patients who require endoscopic retro-grade cholangiopancreatography (ERCP) for suspected choledocolithiasis |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 11/06/2003 |
| Date of final enrolment | 27/02/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Berkshire & Battle Hospitals NHS Trust
Reading
RG1 5AN
United Kingdom
RG1 5AN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
