Trial document



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  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

  •   DRKS00014011
  •   2018/03/20
  •   [---]*
  •   yes
  •   Approved
  •   S-693/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1209-1592 
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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
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Interventions/Observational Groups

  •   Minimal-invasive distal pancreatectomy (MIDP)
  •   Open distal pancreatectomy (ODP)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   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

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/08/03
  •   294
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   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

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    • Medizinische Fakultät der Ruprecht-Karls-Universität Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Markus K.  Diener 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Pascal  Probst 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.