Condition category
Digestive System
Date applied
22/04/2005
Date assigned
26/04/2005
Last edited
27/04/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pancreatitis.nl/

Contact information

Type

Scientific

Primary contact

Prof H G Gooszen

ORCID ID

Contact details

Heidelberglaan 100
Utrecht
3584CX
Netherlands
+31 (0)30 250 8074
h.gooszen@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04-289

Study information

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

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

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).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2005

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

94

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

Trial participating centre

Heidelberglaan 100
Utrecht
3584CX
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

c/o Prof H.G. Gooszen
P.O. Box 85500
Utrecht
3508GA
Netherlands
+31 (0)30 250 8074
h.gooszen@umcutrecht.nl

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 945-06-910)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16606471
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20410514

Publication citations

  1. Protocol

    Besselink MG, van Santvoort HC, Nieuwenhuijs VB, Boermeester MA, Bollen TL, Buskens E, Dejong CH, van Eijck CH, van Goor H, Hofker SS, Lameris JS, van Leeuwen MS, Ploeg RJ, van Ramshorst B, Schaapherder AF, Cuesta MA, Consten EC, Gouma DJ, van der Harst E, Hesselink EJ, Houdijk LP, Karsten TM, van Laarhoven CJ, Pierie JP, Rosman C, Bilgen EJ, Timmer R, van der Tweel I, de Wit RJ, Witteman BJ, Gooszen HG, , Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868]., BMC Surg, 2006, 6, 6, doi: 10.1186/1471-2482-6-6.

  2. Results

    van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Laméris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG, , A step-up approach or open necrosectomy for necrotizing pancreatitis., N. Engl. J. Med., 2010, 362, 16, 1491-1502, doi: 10.1056/NEJMoa0908821.

Additional files

Editorial Notes