Pancreatitis, ENdoscopic transGastric versUs primary necrosectomy in patients with Infected Necrosis
| ISRCTN | ISRCTN07091918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07091918 |
| Protocol serial number | N/A |
| Sponsor | St Antonius Hospital Nieuwegein (Netherlands) |
| Funder | University Medical Centre Utrecht (UMCU) (Netherlands) |
- Submission date
- 11/12/2006
- Registration date
- 28/03/2007
- Last edited
- 21/03/2012
- 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 of protocol
Not provided at time of registration
Contact information
Dr Robin Timmer
Scientific
Scientific
St Antonius Hospital
Department of Gastroenterology
P.O. Box 2500
Nieuwegein
3402 EM
Netherlands
| r.timmer@antonius.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled multicentre observer-blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Pancreatitis, ENdoscopic transGastric versUs primary necrosectomy in patients with Infected Necrosis: a randomised controlled multicentre observer-blinded trial (Dutch Acute Pancreatitis Study Group) |
| Study acronym | PENGUIN |
| Study objectives | Endoscopic transgastric necrosectomy will lead to a reduction of the pre- and post-operative pro-inflammatory response, as compared to necrosectomy by laparotomy, in patients with infected (peri-)pancreatic necrosis. |
| Ethics approval(s) | Regional Medical Ethics Board for the Meander Medical Centre Amersfoort-Baarn-Soest (De Verenigde Commissies Mensgebonden Onderzoek [VCMO]) approved on the 17th April 2007 (ref: LTME/VL-07.08) |
| Health condition(s) or problem(s) studied | Acute necrotising pancreatitis |
| Intervention | Endoscopic transgastric necrosectomy or necrosectomy by laparotomy, followed by continuous post-operative lavage |
| Intervention type | Other |
| Primary outcome measure(s) |
Pro-inflammatory response as measured by the maximum increase in level of serum cytokine Interleukin six (IL-6) in the period between start of the first necrosectomy and five hours thereafter |
| Key secondary outcome measure(s) |
1. Complications (bleeding, perforation, pancreatic fistula, pancreatic pseudocyst requiring intervention, pancreatic abscess requiring intervention, biliary strictures, incisional hernia requiring re-intervention and pancreatic insufficiency) |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Age equal to or above 18 years 2. Pancreatic necrosis or peripancreatic necrosis detected on contrast-enhanced computed tomography (CECT) 3. Patients in whom a decision for surgical intervention has been made because of (suspected) infected (peri-)pancreatic necrosis 4. Safe access route for endoscopic transgastric necrosectomy 5. Written informed consent |
| Key exclusion criteria | 1. Participation in another intervention trial that would interfere with the intervention and outcome of this study 2. Previous surgical necrosectomy for (suspected) infected pancreatic necrosis, including procedures performed in referring hospitals. Previous percutaneous or transgastric drainage is allowed 3. Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy 4. Acute flare-up of chronic pancreatitis 5. Bleeding, abdominal compartment syndrome or perforation of a visceral organ as indication for intervention 6. Post-abdominal surgery necrotising pancreatitis |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/03/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
St Antonius Hospital
Nieuwegein
3402 EM
Netherlands
3402 EM
Netherlands
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 | 14/03/2012 | Yes | No |
