Minimally invasive step up approach versus maximal necrosectomy in patients with acute necrotising pancreatitis
| ISRCTN | ISRCTN13975868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13975868 |
| Secondary identifying numbers | 04-289 |
- Submission date
- 22/04/2005
- Registration date
- 26/04/2005
- Last edited
- 27/04/2010
- 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 H G Gooszen
Scientific
Scientific
Heidelberglaan 100
Utrecht
3584CX
Netherlands
| Phone | +31 (0)30 250 8074 |
|---|---|
| h.gooszen@umcutrecht.nl |
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 | Minimally invasive step up approach versus maximal necrosectomy in patients with acute necrotising pancreatitis: a randomised controlled trial by the Dutch Acute Pancreatitis Study Group |
| Study acronym | PANTER |
| Study hypothesis | Minimally invasive step up approach, as compared to laparotomy, is capable of reducing major morbidity in patients with infected necrotising pancreatitis. |
| Ethics approval(s) | This study is conducted in accordance with the principles of the Declaration of Helsinki and 'good clinical practice' guidelines. The independent medical ethics committees of all 20 participating hospitals have approved the study protocol. Prior to randomisation, written informed consent will be obtained from all patients (alternatively consent by proxy will be obtained for patients who are unable to give consent, e.g., intubated patients). |
| Condition | Infected necrotising pancreatitis |
| Intervention | Minimally invasive step up approach: percutaneous catheter drainage, when necessary followed by minimally invasive surgical necrosectomy versus laparotomy and continuous postoperative lavage. |
| Intervention type | Other |
| Primary outcome measure | Complications and mortality, expressed as the percentage of patients who died or had one or more of the complications listed in the protocol. Each complication will be assessed separately. |
| Secondary outcome measures | 1. Hospital and intensive care stay 2. Total indirect and direct costs 3. Hospital stay after first intervention 4. Duration of intubation after first intervention 5. Quality of life |
| Overall study start date | 01/05/2005 |
| Overall study end date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 94 |
| Participant inclusion criteria | Patients of all Dutch University Medical Centers and 12 teaching hospitals who are diagnosed with (suspected) infected necrotising pancreatitis: 1. Aged equal to or above 18 years 2. Pancreatic necrosis or peripancreatic necrosis detected on CECT 3. Patients in whom a decision for surgical intervention has been made because of (suspected) infected (peri-)pancreatic necrosis 4. Possibility of placing a drain (either percutaneous or endoscopic) in the collection(s) 5. Written informed consent |
| Participant exclusion criteria | 1. Previous percutaneous drainage, endoscopic drainage or surgical necrosectomy for necrotising pancreatitis (endoscopic retrograde cholangio-pancreatography [ERCP] for biliary pancreatitis is allowed) 2. Acute attack in a patient with chronic pancreatitis 3. Participation in another intervention trial that would interfere with the intervention and outcome of this study 4. Acute primary intervention because of acute abdomen, bleeding or perforation of a visceral organ 5. Post-operative (i.e. abdominal surgery) necrotising pancreatitis |
| Recruitment start date | 01/05/2005 |
| Recruitment end date | 31/05/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Heidelberglaan 100
Utrecht
3584CX
Netherlands
3584CX
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
c/o Prof H.G. Gooszen
P.O. Box 85500
Utrecht
3508GA
Netherlands
| Phone | +31 (0)30 250 8074 |
|---|---|
| h.gooszen@umcutrecht.nl | |
| Website | http://www.umcutrecht.nl/zorg/ |
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 945-06-910)
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 | 11/04/2006 | Yes | No | |
| Results article | results | 22/04/2010 | Yes | No |
