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Evaluation of robotic versus open partial pancreaticoduodenectomy – a randomised controlled trial (EUROPA)

Not Applicable
Conditions
Diseases of the pancreatic head requiring partial pancreatoduodenectomy
C25.0
D37.70
Head of pancreas
Registration Number
DRKS00020407
Lead Sponsor
niversitätsklinikum Heidelberg
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
81
Inclusion Criteria

1. Planned elective partial pancreaticoduodenectomy for any indication
2. Possibility to perform RPD and OPD as judged by the treating pancreatic surgeon
3. Age = 18 years
4. Ability of subject to understand character and individual consequences of the clinical trial
5. Written informed consent

Exclusion Criteria

1. Borderline or non-resectable carcinomas of the pancreatic head as defined by the National Comprehensive Cancer Network guidelines (1)
2. Distant metastases
3. American Society of Anaesthesiologists (ASA) Score >3
4. Participation in another interventional trial with interference of intervention and outcome of this trial
5. Expected lack of compliance or language problems

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall postoperative morbidity in terms of the com-prehensive complication index (CCI) within 90 days after index operation.
Secondary Outcome Measures
NameTimeMethod
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