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WithdrawnNCT02269683DAVIDUpdated Jun 1, 2016

Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer

An interventional study of Robot-assisted distal pancreatectomy and Laparoscopic distal pancreatectomy in Pancreatic Tumor, sponsored by Technische Universität Dresden. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-01.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

Why this study was withdrawn
lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Pancreatic Tumor
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Planned multi-visceral and/or vascular resection
  • Evidence of distant metastases
  • Expected lack of compliance
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureRobot-assisted distal pancreatectomy
  • ProcedureLaparoscopic distal pancreatectomy
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What researchers measure

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.

    Time frame: 10 days

07

Study locations

1 site
  • Department of Surgery, University Hospital Dresden
    Dresden, 01307, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02269683
Lead sponsor
Technische Universität Dresden
Responsible party
Sponsor
First posted
Oct 21, 2014
Primary completion
Nov 2015 (estimated)
Last update
Jun 1, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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