Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Feb 22;11(2):e047867.
doi: 10.1136/bmjopen-2020-047867.

Protocol for a randomised controlled trial to compare postoperative complications between minimally invasive and open DIStal PAnCreaTectomy (DISPACT-2 trial)

Pascal Probst  1   2 , Fabian Schuh  3   2 , Colette Dörr-Harim  2 , Anja Sander  4 , Thomas Bruckner  4 , Christina Klose  4 , Inga Rossion  2 , Felix Nickel  3 , Beat Peter Müller-Stich  3 , Arianeb Mehrabi  3 , Thilo Hackert  3 , Markus W Büchler  3 , Markus K Diener  2
Affiliations

Protocol for a randomised controlled trial to compare postoperative complications between minimally invasive and open DIStal PAnCreaTectomy (DISPACT-2 trial)

Pascal Probst et al. BMJ Open. .

Abstract

Introduction: In recent years, minimally invasive distal pancreatectomy (MIDP) has been used with increasing frequency to accelerate patient recovery. Distal pancreatectomy has an overall morbidity rate of 30%-40%. The known advantages of minimally invasive techniques must be rigorously compared with those of open surgery before they can be completely implemented into clinical practice.

Methods and analysis: DISPACT-2 is a multicentre randomised controlled trial comparing minimally invasive (conventional laparoscopic or robotic assisted) with open distal pancreatic resection in patients undergoing elective surgery for benign as well as malign diseases of the pancreatic body and tail. After screening for eligibility and obtaining informed consent, a total of 294 adult patients will be preoperatively randomised in a 1:1 ratio. The primary hypothesis is that MIDP is non-inferior to open distal pancreatectomy in terms of postoperative mortality and morbidity expressed as the Comprehensive Complication Index (CCI) within 3 months after index operation, with a non-inferiority margin of 7.5 CCI points. Secondary endpoints include pancreas-specific complications, oncological safety and patient reported outcomes. Follow-up for each individual patient will be 2 years.

Ethics and dissemination: The DISPACT-2 trial has been approved by the Ethics Committee of the medical faculty of Heidelberg University (S-693/2017). Results of the primary endpoint will be available in 2024 and will be published at national and international meetings. Full results will be made available in an open access, peer-reviewed journal. The website www.dispact.de contains up-to-date information regarding the trial.

Trial registration number: DRKS00014011.

Keywords: minimally invasive surgery; pancreatic disease; pancreatic surgery.

PubMed Disclaimer

Conflict of interest statement

Competing interests: FN reports receiving travel support for conference participation as well as equipment provided for laparoscopic surgery courses by KARL STORZ, Johnson & Johnson, Intuitive Surgical, Cambridge Medical Robotics and Medtronic. None of the other authors has a secondary interest according to the ICMJE guidelines that could inappropriately influence their contributions to this work.

Figures

Figure 1
Figure 1
CONSORT flow chart. CONSORT, Consolidated Standards of Reporting Trials; POD, postoperative day.
See this image and copyright information in PMC

References

    1. Lillemoe KD, Kaushal S, Cameron JL, et al. . Distal pancreatectomy: indications and outcomes in 235 patients. Ann Surg 1999;229:693–8. 10.1097/00000658-199905000-00012 - DOI - PMC - PubMed
    1. Bassi C, Dervenis C, Butturini G, et al. . International Study Group on pancreatic fistula definition: postoperative pancreatic fistula: an international Study Group (ISGPF) definition. Surgery 2005;138:8–13. - PubMed
    1. Wente MN, Veit JA, Bassi C, et al. . Postpancreatectomy hemorrhage (PPH): an international Study group of pancreatic surgery (ISGPS) definition. Surgery 2007;142:20–5. 10.1016/j.surg.2007.02.001 - DOI - PubMed
    1. Probst P, Hüttner FJ, Klaiber U, et al. . Stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy. Cochrane Database Syst Rev 2015;11:CD008688. 10.1002/14651858.CD008688.pub2 - DOI - PMC - PubMed
    1. Wente MN, Bassi C, Dervenis C, et al. . Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study group of pancreatic surgery (ISGPS). Surgery 2007;142:761–8. 10.1016/j.surg.2007.05.005 - DOI - PubMed

Publication types

MeSH terms

Associated data

LinkOut - more resources