Pancreatitis, ENdoscopic transGastric versUs primary necrosectomy in patients with Infected Necrosis

ISRCTN	ISRCTN07091918
DOI	https://doi.org/10.1186/ISRCTN07091918
Secondary identifying numbers	N/A

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

St Antonius Hospital
Department of Gastroenterology
P.O. Box 2500
Nieuwegein
3402 EM
Netherlands

Email	r.timmer@antonius.net

Study information

Study design	Randomised controlled multicentre observer-blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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
Secondary outcome measures	1. Complications (bleeding, perforation, pancreatic fistula, pancreatic pseudocyst requiring intervention, pancreatic abscess requiring intervention, biliary strictures, incisional hernia requiring re-intervention and pancreatic insufficiency) 2. Mortality 3. Total number of interventions 4. Total hospital stay 5. Total intensive care stay
Overall study start date	01/03/2007
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	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

Sponsor information

St Antonius Hospital Nieuwegein (Netherlands)
Hospital/treatment centre

Department of Gastroenterology
P.O. Box 2500
Nieuwegein
3402 EM
Netherlands

Website	http://www.antonius.net/rood/english.php
"ROR"	https://ror.org/01jvpb595

Funders

Funder type

Hospital/treatment centre

University Medical Centre Utrecht (UMCU) (Netherlands)

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?
Results article	results	14/03/2012		Yes	No