Trial document
DRKS00014011
Trial Description
Title
Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial)
Trial Acronym
DISPACT 2
URL of the Trial
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.
Do you plan to share individual participant data with other researchers?
Yes
Description IPD sharing plan:
After publication the data set will be available upon request for further research also to non-participating parties.
Organizational Data
- DRKS00014011
- 2018/03/20
- [---]*
- yes
- Approved
- S-693/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
Secondary IDs
- U1111-1209-1592
Health Condition or Problem studied
- C25.1 - Malignant neoplasm: Body of pancreas
- C25.2 - Malignant neoplasm: Tail of pancreas
- C25.3 - Malignant neoplasm: Pancreatic duct
- C25.4 - Malignant neoplasm: Endocrine pancreas
- C25.7 - Malignant neoplasm: Other parts of pancreas
- K86.0 - Alcohol-induced chronic pancreatitis
- K86.1 - Other chronic pancreatitis
- D13.6 - Benign neoplasm: Pancreas
Interventions/Observational Groups
- Minimal-invasive distal pancreatectomy (MIDP)
- Open distal pancreatectomy (ODP)
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Blinded
- assessor
- Active control (effective treament of control group)
- Treatment
- Parallel
- N/A
- N/A
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
Countries of Recruitment
- Germany
- United Kingdom
- Slovenia
Locations of Recruitment
- University Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- Medical Center
Recruitment
- Actual
- 2020/08/13
- 294
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- 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
-
start of 1:1-Block address primary-sponsor
- Medizinische Fakultät der Ruprecht-Karls-Universität Heidelberg
- Im Neuenheimer Feld 672
- 69120 Heidelberg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg
- Mr. Prof. Dr. med. Markus K. Diener
- Hugstetter Straße 55
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0761-270-61200
- 0761 270 90781
- markus.diener at uniklinik-freiburg.de
- https://www.uniklinik-freiburg.de/chirurgie.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Heidelberg
- Ms. Dr. med. Rosa Klotz
- Im Neuenheimer Feld 420
- 69120 Heidelberg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 06221-5634726
- 06221-56 33850
- rosa.klotz at med.uni-heidelberg.de
- https://www.klinikum.uni-heidelberg.de/chirurgische-klinik-zentrum/allgemein-viszeral-und-transplantationschirurgie
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.dfg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
- [---]*
- [---]*
- [---]*
- [---]*
Trial Publications, Results and other Documents
- [---]*