Study Stopped
lack of funding
Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer
DAVID
Randomized Controlled Trial of Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer - The DAVID-study
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The present randomized controlled trial evaluates the incidence of R1 resections in patients undergoing robotic distal pancreatectomy compared to the laparoscopic technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedJune 1, 2016
May 1, 2016
October 17, 2014
May 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
R1 resection rate
Proportion of patients with complete macroscopic resection, but microscopic residual tumour. Pathological evaluation will be performed by experienced, board-certified pathologists using standardized protocols according to current guidelines. Importantly, pathologists will be blinded for patients treatment group.
10 days
Study Arms (2)
Robot-assisted
EXPERIMENTALDistal pancreatectomy via robot-assisted minimally-invasive approach
Laparoscopic
ACTIVE COMPARATORDistal pancreatectomy via a conventional laparoscopic approach
Interventions
Eligibility Criteria
You may qualify if:
- Suspected malignant disease of the pancreas scheduled for distal pancreatectomy
- Patient eligible for laparoscopic resection
- ≥ 18 years of age
- Written informed consent
You may not qualify if:
- Planned multi-visceral and/or vascular resection
- Evidence of distant metastases
- Expected lack of compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, University Hospital Dresden
Dresden, 01307, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 21, 2014
Primary Completion
November 1, 2015
Last Updated
June 1, 2016
Record last verified: 2016-05