Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer (DAVID)
Primary Purpose
Pancreatic Tumor
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Robot-assisted distal pancreatectomy
Laparoscopic distal pancreatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Tumor
Eligibility Criteria
Inclusion Criteria:
- Suspected malignant disease of the pancreas scheduled for distal pancreatectomy
- Patient eligible for laparoscopic resection
- ≥ 18 years of age
- Written informed consent
Exclusion Criteria:
- Planned multi-visceral and/or vascular resection
- Evidence of distant metastases
- Expected lack of compliance
Sites / Locations
- Department of Surgery, University Hospital Dresden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot-assisted
Laparoscopic
Arm Description
Distal pancreatectomy via robot-assisted minimally-invasive approach
Distal pancreatectomy via a conventional laparoscopic approach
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02269683
First Posted
October 17, 2014
Last Updated
May 31, 2016
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT02269683
Brief Title
Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer
Acronym
DAVID
Official Title
Randomized Controlled Trial of Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer - The DAVID-study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
undefined (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present randomized controlled trial evaluates the incidence of R1 resections in patients undergoing robotic distal pancreatectomy compared to the laparoscopic technique.
Detailed Description
Surgical resection the only potentially curative therapeutic approach in patients with pancreatic cancer. Among the clinicopathologic factors that are associated with long-term survival, a complete (i.e. R0) tumor resection is of utmost significance. Numerous reports have already demonstrated detection of tumor cells at the resection margin on microscopic examination (i.e. R1 resection) is associated with poor long-term survival. However, studies using a standardized pathological work-up of operative specimen from patients with pancreatic cancer revealed that most pancreatic resections are R1 resections. Innovative surgical techniques that reduce the incidence of R1 resections may provide a promising approach to improve the outcome of patients with pancreatic cancer.
For patients requiring a distal pancreatectomy, a laparoscopic pancreatic resection is increasingly performed, as it may enhance postoperative recovery without compromising oncological safety compared to the open approach. However, laparoscopic technique does not affect the proportion of patients with complete (R0) resections. Furthermore, the inability to control major vasculature frequently results in conversion to the open approach. The vast majority of R1 margins are located at the retroperitoneal dissection surface. Due to technical limitations, the open and the laparoscopic technique may not further reduce the incidence of positive resection margins at this location.
The 3D visualization provided by the robotic approach together with improved dexterity of the surgeon are likely to enable a meticulous dissection at the posterior dissection margin. This may result in a significant reduction of patients with positive resection margins. However, to date there has been no randomized controlled trial that compared the robotic to the laparoscopic technique. As health-care interventions need to prove efficacy and safety in well-designed randomized controlled trials, the present randomized controlled trial was designed to test, if robotic distal pancreatectomy increases the incidence of patients with complete (R0) tumor resection for pancreatic cancer. Secondary endpoints include oncological parameters such as the number of harvested lymph nodes and factors of perioperative outcome such as perioperative complications (Clavien-Dindo classification), pancreatic fistula, in-hospital mortality, blood loss and conversion rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot-assisted
Arm Type
Experimental
Arm Description
Distal pancreatectomy via robot-assisted minimally-invasive approach
Arm Title
Laparoscopic
Arm Type
Active Comparator
Arm Description
Distal pancreatectomy via a conventional laparoscopic approach
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted distal pancreatectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic distal pancreatectomy
Primary Outcome Measure Information:
Title
R1 resection rate
Description
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.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected malignant disease of the pancreas scheduled for distal pancreatectomy
Patient eligible for laparoscopic resection
≥ 18 years of age
Written informed consent
Exclusion Criteria:
Planned multi-visceral and/or vascular resection
Evidence of distant metastases
Expected lack of compliance
Facility Information:
Facility Name
Department of Surgery, University Hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
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Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer
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