Condition category
Digestive System
Date applied
18/07/2006
Date assigned
26/07/2006
Last edited
02/06/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Markus W. Büchler

ORCID ID

Contact details

Department of General
Visceral and Trauma Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0) 62 2156 6986
markus.buechler@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SDGC 01/2004

Study information

Scientific title

Acronym

DISPACT-Trial

Study hypothesis

The trial is designed to show that the risk of developing a pancreatic fistula and/or death until day seven after the surgical procedure can be reduced by stapler-closure of the pancreatic remnant compared to scalpel transsection and hand-sewn suture following distal pancreatectomy.

Ethics approval

Ethics approval received from the Ethikkommission der Medizinischen Fakultät Heidelberg on the 10th August 2006 (1st vote), 28th August 2006 (final vote), 4th October 2006 (Amendment I), 26th January 2007 (Amendment II) (ref: 245/2006).

Study design

A multi-centre (20 international centres), pre-operatively randomised, controlled and patient and observer blinded trial performed as a parallel group adaptive superiority design.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diseases of the pancreatic body and tail

Intervention

Distal pancreatectomy:
1. Experimental group: stapler resection
2. Control group: scalpel resection and hand-suture of the pancreatic stump

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The combined primary endpoint is the presence of a pancreatic fistula and/or death due to any cause on day seven post-operatively.

Secondary outcome measures

1. Operating time
2. Frequencies of burst abdomen, wound infection, and intra-abdominal fluid collection and abscess
3. Post-operative length of hospital stay
4. New onset of diabetes mellitus
5. One-year survival

Overall trial start date

01/12/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age equal or above 18 years
2. Expected survival time more than 12 months
3. Patients with at least one of the following pathologic diseases scheduled for elective resection:
3.1. Resectable malignancies of the pancreatic body and/or tail
3.2. Resectable chronic pancreatitis of the body and/or tail
3.3. Resectable benign tumours of the pancreas including neuroendocrine tumours
3.4. Resectable pseudocyst of the pancreatic body and/or tail

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of approximately 450 patients will be randomised

Participant exclusion criteria

1. Current immunosuppressive therapy
2. Chemotherapy within two weeks before operation
3. Radiotherapy within eight weeks before operation
4. Curative resection is not feasible
5. Severe psychiatric or neurologic diseases
6. Drug and/or alcohol abuse according to local standards
7. Participation in another intervention trial with interference of intervention or outcome
8. Inability to follow the instructions given by the investigator or interviewer
9. Expected lack of compliance
10. Lack of informed consent

Recruitment start date

01/12/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Germany, Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom

Trial participating centre

Department of General, Visceral and Trauma Surgery
Heidelberg
69120
Germany

Sponsor information

Organisation

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Sponsor details

Study Centre of the German Surgical Society (SDGC)
Department of General
Visceral and Trauma Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)62 2156 6986
sdgc@med.uni-heidelberg.de

Sponsor type

University/education

Website

http://www.sdgc.de

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19630998
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21529927

Publication citations

  1. Results

    Bruns H, Rahbari NN, Löffler T, Diener MK, Seiler CM, Glanemann M, Butturini G, Schuhmacher C, Rossion I, Büchler MW, Junghans T, , Perioperative management in distal pancreatectomy: results of a survey in 23 European participating centres of the DISPACT trial and a review of literature., Trials, 2009, 10, 58, doi: 10.1186/1745-6215-10-58.

  2. Results

    Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Büchler MW, Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial., Lancet, 2011, 377, 9776, 1514-1522, doi: 10.1016/S0140-6736(11)60237-7.

Additional files

Editorial Notes