Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02269683
Study type Interventional
Source Technische Universität Dresden
Contact
Status Withdrawn
Phase N/A

See also
  Status Clinical Trial Phase
Completed NCT01673334 - Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms Phase 4
Recruiting NCT01978808 - Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic Masses N/A
Completed NCT01479803 - Comparison of Two Needles (ProCore vs EchoTip) for the Diagnosis of Pancreatic Solid Mass Under EUS Phase 3
Completed NCT02716207 - Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife N/A
Withdrawn NCT01434550 - Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer N/A
Completed NCT03444051 - Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors N/A
Recruiting NCT05794048 - METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors N/A
Recruiting NCT05871164 - Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
Recruiting NCT03558945 - Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor Phase 1
Recruiting NCT01969110 - Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy Phase 4
Completed NCT02330497 - Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor N/A
Completed NCT01692873 - Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors N/A
Recruiting NCT04075305 - The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Recruiting NCT04357483 - Effect of Thrombin-containing Collagen-based Hemostatic Matrix Phase 4
Recruiting NCT01698190 - Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions N/A
Completed NCT03340844 - Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors N/A
Withdrawn NCT02534246 - Head to Head Comparison of Two Needles EUS Guided FNB N/A
Not yet recruiting NCT01819961 - Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery Phase 4