Clinical trial to compare duodenum preserving pancreatic head resection according to Beger versus the Berne modification in patients with chronic pancreatitis: a randomised controlled trial
| ISRCTN | ISRCTN50638764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50638764 |
| Secondary identifying numbers | KSC 06/2003 |
- Submission date
- 27/05/2004
- Registration date
- 01/09/2004
- Last edited
- 30/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Markus W Büchler
Scientific
Scientific
University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 6200 |
|---|---|
| markus.buechler@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DEPKR-Trial |
| Study hypothesis | To compare two different surgical techniques for the treatment of chronic pancreatitis with regard to complication rates, length of operation, length of intensive care treatment, length of hospital stay, exocrine/endocrine pancreatic function and quality of life. |
| Ethics approval(s) | Ethics approval received from the Independent Ethics Committee of the University of Heidelberg. |
| Condition | Chronic pancreatitis |
| Intervention | Every patient eligible for pancreatic head resection due to chronic pancreatitis will be asked for informed consent and will be thereafter intraoperatively randomised to either Beger's or the Berne modification of duodenum-preserving pancreatic head resection. A standardised surgical abdominal approach is performed in preparing the pancreatic head. The randomisation will proceed when the intraoperative decision for resection of the pancreatic head is made. The comparison of specific primary and secondary endpoints will assess the superiority of one technique. Patients will be followed up for 24 months. |
| Intervention type | Other |
| Primary outcome measure | The primary endpoint is combined out of four components. In order to adjust for multiple testing a hierarchical model is used. 1. Duration of surgical procedure [min] 2. Quality of life (EORTC QLQ-C30 questionnaire and the disease specific module for pancreatic diseases EORTC QLQ-PAN26) at 12 months after the intervention 3. Duration of stay on the intensive care unit 4. Duration of postoperative hospital stay |
| Secondary outcome measures | Frequencies of early and late onset complications such as intra- or postoperative bleeding with subsequent need for blood transfusion, pancreatic fistula, postoperative pulmonary complications, wound infections and re-laparotomy; exocrine and endocrine pancreatic function as determined by levels of HbA1c and stool elastase. |
| Overall study start date | 01/09/2003 |
| Overall study end date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 65 |
| Participant inclusion criteria | Patients undergoing elective duodenum-preserving pancreatic head resection due to chronic pancreatitis. Eligibility criteria: 1. Patients of any age (greater than 18 years) 2. Expected survival time more than 24 months 3. Informed consent |
| Participant exclusion criteria | 1. Participation in another intervention trial that would interfere with the intervention and outcome of this study 2. Severe psychiatric disorders or neurological diseases 3. Lack of compliance 4. Drug and/or alcohol abuse according to local standards |
| Recruitment start date | 01/09/2003 |
| Recruitment end date | 01/10/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Heidelberg Medical School
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg Medical School (Germany)
University/education
University/education
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 6987 |
|---|---|
| Markus_Buechler@med.uni-heidelberg.de | |
| Website | http://med.uni-hd.de/index_eng.html |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
University/education
University of Heidelberg Medical School (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 08/05/2006 | Yes | No | |
| Results article | Results | 01/04/2008 | Yes | No |
