Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head
| ISRCTN | ISRCTN38973832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38973832 |
| Protocol serial number | SDGC 01/2009 |
| Sponsor | Study Centre of the German Surgical Society (SDGC) (Germany) |
| Funder | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: ChroPac SE 1682/2-1) |
- Submission date
- 21/04/2009
- Registration date
- 30/04/2009
- Last edited
- 28/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 6986 |
|---|---|
| Christoph.Seiler@med.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled observer and patient blinded multicentre surgical trial with two parallel study groups |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head: a randomised controlled multicentre trial |
| Study acronym | ChroPac |
| Study objectives | The two-sided null-hypothesis states that both surgical interventions lead to the same average quality of life (QoL) scores during 24 months after surgery. The two-sided alternative-hypothesis states that the two interventions perform differently in terms of the primary efficacy endpoint. |
| Ethics approval(s) | Ethics Committee of the University of Heidelberg, approved on 20/04/2009 (ref: S-029/2009) |
| Health condition(s) or problem(s) studied | Chronic pancreatitis |
| Intervention | Experimental intervention: Any surgical technique that removes inflamed pancreatic tissue of the head without resection of the duodenum (e.g. Beger, Frey or Berne procedure). Control intervention: Pylorus preserving/classic Whipple procedure. |
| Intervention type | Other |
| Primary outcome measure(s) |
Average QoL during 24 months after surgery, measured 6, 12 and 24 months after surgery by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) scale "physical functioning". The primary efficacy analysis will be conducted for the intention-to-treat population. An analysis of covariance (ANCOVA) model will be applied for the intervention group comparison adjusting for age, centre and EORTC QLQ-C30 scale "physical functioning" before surgery. The level of significance is set at 5% (two-sided) and sample size is determined to assure a power of 1-beta = 90%. |
| Key secondary outcome measure(s) |
Exploratory analyses |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Patients (no age or gender restrictions) with chronic pancreatitis of the head and pain, eligible for elective surgical resection 2. Ability of subject to understand character and individual consequences of the clinical trial 3. Written informed consent |
| Key exclusion criteria | Participation in another intervention-trial with interference of intervention and outcome of this study |
| Date of first enrolment | 18/05/2009 |
| Date of final enrolment | 30/06/2013 |
Locations
Countries of recruitment
- United Kingdom
- Germany
- Netherlands
- Slovenia
Study participating centre
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/09/2017 | Yes | No | |
| Protocol article | protocol | 29/04/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/08/2018: Publication reference added.
