Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer (DAVID)

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

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

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Tumor
• Intervention / Treatment: Procedure: Robot-assisted distal pancreatectomy; Procedure: Laparoscopic distal pancreatectomy

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Department of Surgery, University Hospital Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Primary Completion (ANTICIPATED): November 1, 2015

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (ESTIMATE): October 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: VTG-02