N/A
2015-11
N/A
0
NCT02269683
Technische Universität Dresden
Technische Universität Dresden
INTERVENTIONAL
Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer
The present randomized controlled trial evaluates the incidence of R1 resections in patients undergoing robotic distal pancreatectomy compared to the laparoscopic technique.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2014-10-17 | N/A | 2016-05-31 |
2014-10-17 | N/A | 2016-06-01 |
2014-10-21 | N/A | 2016-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Robot-assisted Distal pancreatectomy via robot-assisted minimally-invasive approach | PROCEDURE: Robot-assisted distal pancreatectomy |
ACTIVE_COMPARATOR: Laparoscopic Distal pancreatectomy via a conventional laparoscopic approach | PROCEDURE: Laparoscopic distal pancreatectomy |
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 |
Secondary Outcome Measures | Measure Description | Time Frame |
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This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available