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Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial)

Organizational Data

DRKS-ID:
DRKS00014011
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2018-03-20
Last update in DRKS:
2022-03-17
Registration type:
Prospective

Acronym/abbreviation of the study

DISPACT 2

URL of the study

http://dispact.de

Brief summary in lay language

The success of an operation not only depends on the disease, but also on the damage of the surgical approach. Minimal invasive surgery reduces postoperative pain and results in improved mobility, fewer pulmonary infections and faster recovery and a better quality of life. The DISPACT 2 study examines differences between open and minimal invasive distal pancreatic resection for postoperative complications, further clinical and oncological efficacy, safety, quality of life and costs. In addition, patient-relevant outcomes and oncological safety are examined. In the case of the same number of postoperative complications and given oncological safety and at the same time improved quality of life, minimal invasive resection should be offered to patients as the first choice.

Brief summary in scientific language

Open distal pancreatectomy is the gold standard for surgical treatment of diseases of the pancreatic body and tail. The open abdominal approach itself with its increased surgical trauma compared to minimal invasive distal pancreatectomy is suspected to cause increased postoperative morbidity affecting both the patient and the healthcare system. A systematic review, performed by our group, showed reduced postoperative morbidity after laparoscopic versus open abdominal approaches across the whole field of abdominal surgery. The minimal invasive approach with its reduced invasiveness promises reduction of postoperative pain and subsequently better mobilisation of patients and less respiratory complications leading to a quicker recovery and a shorter length of hospital stay. Therefore, in presence of the same postoperative morbidity the minimal invasive approach should be offered to patients as first choice.

Health condition or problem studied

ICD10:
C25.1 - Body of pancreas
ICD10:
C25.2 - Tail of pancreas
ICD10:
C25.3 - Pancreatic duct
ICD10:
C25.4 - Endocrine pancreas
ICD10:
C25.7 - Other parts of pancreas
ICD10:
K86.0 - Alcohol-induced chronic pancreatitis
ICD10:
K86.1 - Other chronic pancreatitis
ICD10:
D13.6 - Pancreas
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Minimal-invasive distal pancreatectomy (MIDP)
Arm 2:
Open distal pancreatectomy (ODP)

Endpoints

Primary outcome:
Postoperative mortality and morbidity assessed as comprehensive complication index (CCI) 3 months after intervention.
Secondary outcome:
- Operation time - Intraoperative blood loss - Conversion rate (minimal-invasive group) - Days on ICU - Pain (NRS) - Mobility - Length of hospital stay - Time to functional recovery - Pancreas-associated morbidity (pancreatic fistula, delayed gastric emptying, postoperative hemorrhage) - Surgical site infection - Re-intervention rate - Time to return to work - Quality of Life (EORTC QLQ-C30 and PAN 28 (CP)) - Incisional hernia rate - Survival rate after 12 and 24 months - R0 / R1 resection rates - Lymph node count in oncological group - DRG case cost

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • Slovenia
  • United Kingdom
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg
  • University medical center Department Chirurgie Klinik für Allgemein- und Viszeralchirurgie Freiburg im Breisgau
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Frankfurt der Goethe Universität Frankfurt a.M.
  • University medical center Klinik und Poliklinik für Chirurgie, Klinikum Rechts der Isar TU München München
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg
  • University medical center Department Chirurgie Klinik für Allgemein- und Viszeralchirurgie Freiburg im Breisgau
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Frankfurt der Goethe Universität Frankfurt a.M.
  • University medical center Klinik und Poliklinik für Chirurgie, Klinikum Rechts der Isar TU München München
  • University medical center Klinik für Allgemein-, Viszeral-, Gefäß- und Kinderchirurgie, Universitätsklinikum des Saarlandes Homburg
  • Medical center Klinik für Viszeral-, Tumor-, Transplantations- und Gefäßchirurgie, Universitätsklinikum der privaten Universität Witten/Herdecke Köln-Merheim
  • University medical center Klinik für Visceral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Marburg Gießen GmbH Marburg
  • University medical center Royal Liverpool University Hospital Liverpool
  • University medical center Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus Dresden Dresden
  • University medical center Uniklinik RWTH Aachen Klinik für Allgemein,- Viszeral- und Transplantationschirurgie Aachen
  • University medical center Dept. of Abdominal Surgery, University Medical Centre Ljubljana Ljubljana
  • University medical center Klinik für Chirurgie, Universitätsklinikum Schleswig-Holstein Lübeck
  • University medical center Klinik für Allgemein- und Viszeralchirurgie Ulm
  • University medical center Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie Bonn
  • University medical center Universitätsklinik und Poliklinik für Viszerale, Gefäß- und Endokrine Chirurgie Halle Saale
  • Medical center Klinik für Allgemein -, Visceral -, Gefäß - und Thoraxchirurgie Memmingen
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, LMU München
  • Medical center Klinikum der Landeshauptstadt Stuttgart gKAöR, Katharinenhospital, Klinik Klinik für Allgemein-, Viszeral-, Thorax- und Transplantationschirurgie Stuttgart
  • Medical center Ostalb-Klinikum Aalen, Chirurgische Klinik I Aalen
  • University medical center Allgemein-, Viszeral- und spezielle Viszeralchirurgie, Universitätsklinikum Erlangen Erlangen
  • Medical center Klinik Helios Amper-Klinikum Dachau, Klinik für Allgemein-, Viszeral-, Thorax- und Onkologische Chirurgie Dachau

Recruitment period and number of participants

Planned study start date:
2020-08-03
Actual study start date:
2020-08-13
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
294
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- Planned distal pancreatectomy with or without splenectomy for any indication - Age ≥ 18 years - Ability of subject to understand character and individual consequences of the clinical trial - Written informed consent

Exclusion Criteria

- Patients scheduled for a pancreatic resection other than distal pancreatectomy - Distant organ metastases or tumour infiltration of the superior mesenteric vein, superior mesenteric artery or hepatic artery - Infiltration of adjacent organs - CA 19-9 >1000 IU/ml - ASA >3 - Prior major open abdominal surgery - Participation in another intervention-trial with interference of intervention and outcome of this study - Lack of compliance and lack of written informed consent

Addresses

Primary Sponsor

Medizinische Fakultät der Ruprecht-Karls-Universität Heidelberg
Im Neuenheimer Feld 672
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg
Prof. Dr. med. Markus K. Diener
Hugstetter Straße 55
79106 Freiburg
Germany
Telephone:
0761-270-61200
Fax:
0761 270 90781
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/chirurgie.html

Contact for Public Queries

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Heidelberg
Dr. med. Rosa Klotz
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
06221-5634726
Fax:
06221-56 33850
Contact per E-Mail
URL:
https://www.klinikum.uni-heidelberg.de/chirurgische-klinik-zentrum/allgemein-viszeral-und-transplantationschirurgie

Principal Investigator

Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg
Prof. Dr. med. Markus K. Diener
Hugstetter Straße 55
79106 Freiburg
Germany
Telephone:
0761-270-61200
Fax:
0761 270 90781
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/chirurgie.html

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Deutsche Forschungsgemeinschaft
Kennedyallee 40
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dfg.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-12-18
Ethics committee number:
S-693/2017
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-01-04

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1209-1592
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
After publication the data set will be available upon request for further research also to non-participating parties.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry