Trial document

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DRKS-ID: DRKS00014011

Trial Description

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Title

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

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Trial Acronym

DISPACT 2

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URL of the Trial

http://dispact.de

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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.

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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.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

After publication the data set will be available upon request for further research also to non-participating parties.

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Organizational Data

DRKS-ID: DRKS00014011
Date of Registration in DRKS: 2018/03/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: S-693/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg

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Secondary IDs

Universal Trial Number (UTN): U1111-1209-1592

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Health Condition or Problem studied

ICD10: C25.1 - Malignant neoplasm: Body of pancreas
ICD10: C25.2 - Malignant neoplasm: Tail of pancreas
ICD10: C25.3 - Malignant neoplasm: Pancreatic duct
ICD10: C25.4 - Malignant neoplasm: Endocrine pancreas
ICD10: C25.7 - Malignant neoplasm: Other parts of pancreas
ICD10: K86.0 - Alcohol-induced chronic pancreatitis
ICD10: K86.1 - Other chronic pancreatitis
ICD10: D13.6 - Benign neoplasm: Pancreas

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Interventions/Observational Groups

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

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: assessor
Control: Active control (effective treament of control group)
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Postoperative mortality and morbidity assessed as comprehensive complication index (CCI) 3 months after intervention.

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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

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Countries of Recruitment

DE: Germany
UK: United Kingdom
SI: Slovenia

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Locations of Recruitment

University Medical Center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Heidelberg
University Medical Center Uniklinik RWTH Aachen Klinik für Allgemein,- Viszeral- und Transplantationschirurgie, Aachen
Medical Center Ostalb-Klinikum Aalen, Chirurgische Klinik I, Aalen
University Medical Center Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie, Bonn
University Medical Center Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus Dresden, Dresden
University Medical Center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Frankfurt der Goethe Universität, Frankfurt a.M.
University Medical Center Department Chirurgie Klinik für Allgemein- und Viszeralchirurgie, Freiburg im Breisgau
University Medical Center Universitätsklinik und Poliklinik für Viszerale, Gefäß- und Endokrine Chirurgie, Halle Saale
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 Royal Liverpool University Hospital, Liverpool
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 Visceral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Marburg Gießen GmbH, Marburg
Medical Center Klinik für Allgemein -, Visceral -, Gefäß - und Thoraxchirurgie , Memmingen
University Medical Center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, LMU , München
University Medical Center Klinik und Poliklinik für Chirurgie, Klinikum Rechts der Isar TU München, München
University Medical Center Klinik für Allgemein- und Viszeralchirurgie, Ulm
Medical Center Klinik Helios Amper-Klinikum Dachau, Klinik für Allgemein-, Viszeral-, Thorax- und Onkologische Chirurgie, Dachau
University Medical Center Allgemein-, Viszeral- und spezielle Viszeralchirurgie, Universitätsklinikum Erlangen, Erlangen
Medical Center Klinikum der Landeshauptstadt Stuttgart gKAöR, Katharinenhospital, Klinik Klinik für Allgemein-, Viszeral-, Thorax- und Transplantationschirurgie, Stuttgart

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2020/08/13
Target Sample Size: 294
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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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

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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

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Addresses

Primary Sponsor
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- Medizinische Fakultät der Ruprecht-Karls-Universität Heidelberg
- Im Neuenheimer Feld 672
- 69120 Heidelberg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg
- Mr. Prof. Dr. med. Markus K. Diener
- Hugstetter Straße 55
- 79106 Freiburg
- Germany
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- Telephone: 0761-270-61200
- Fax: 0761 270 90781
- E-mail: markus.diener at uniklinik-freiburg.de
- URL: https://www.uniklinik-freiburg.de/chirurgie.html
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Contact for Public Queries
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- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Heidelberg
- Ms. Dr. med. Rosa Klotz
- Im Neuenheimer Feld 420
- 69120 Heidelberg
- Germany
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- Telephone: 06221-5634726
- Fax: 06221-56 33850
- E-mail: rosa.klotz at med.uni-heidelberg.de
- URL: https://www.klinikum.uni-heidelberg.de/chirurgische-klinik-zentrum/allgemein-viszeral-und-transplantationschirurgie
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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.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting ongoing
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: [---]*
Total Number of Participants (all Sites worldwide) after Recruiting complete: [---]*

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Trial Publications, Results and other Documents

[---]*

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* This entry means the parameter is not applicable or has not been set.