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

Not Applicable

Recruiting

Conditions: K86.1
D13.6
C25.1
C25.2
C25.3
C25.4
C25.7
K86.0
Body of pancreas
Tail of pancreas

Registration Number: DRKS00014011

Lead Sponsor: Medizinische Fakultät der Ruprecht-Karls-Universität Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 294

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- Operation time<br>- Intraoperative blood loss<br>- Conversion rate (minimal-invasive group)<br>- Days on ICU<br>- Pain (NRS)<br>- Mobility <br>- Length of hospital stay<br>- Time to functional recovery<br>- Pancreas-associated morbidity (pancreatic fistula, delayed gastric emptying, postoperative hemorrhage)<br>- Surgical site infection<br>- Re-intervention rate<br>- Time to return to work<br>- Quality of Life (EORTC QLQ-C30 and PAN 28 (CP))<br>- Incisional hernia rate<br>- Survival rate after 12 and 24 months<br>- R0 / R1 resection rates<br>- Lymph node count in oncological group<br>- DRG case cost <br>