Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer

Study Overview
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Brief Summary
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The present randomized controlled trial evaluates the incidence of R1 resections in patients undergoing robotic distal pancreatectomy compared to the laparoscopic technique.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer - The DAVID-study

Conditions
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Pancreatic Tumor

Intervention / Treatment
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* Procedure: Robot-assisted distal pancreatectomy
* Procedure: Laparoscopic distal pancreatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted<br>Distal pancreatectomy via robot-assisted minimally-invasive approach | Procedure: Robot-assisted distal pancreatectomy<br> <br> |
| Active Comparator: Laparoscopic<br>Distal pancreatectomy via a conventional laparoscopic approach | Procedure: Laparoscopic distal pancreatectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |