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Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors

NCT04400357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2025-12-18

No results posted yet for this study

Summary

This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.

Conditions

  • Pancreatic Adenocarcinoma
  • Pancreatic Cysts
  • Pancreatic Endocrine Tumors
  • Chronic Pancreatitis
  • Cholangiocarcinoma, Extrahepatic
  • Ampullary Adenocarcinoma
  • Duodenal Adenocarcinoma

Interventions

PROCEDURE

Robotic pancreaticoduodenectomy

Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.

PROCEDURE

Open pancreaticoduodenectomy

Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.

Sponsors & Collaborators

  • Intuitive Surgical

    collaborator INDUSTRY

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Baiyong Shen, PhD · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2024-11-28
Completion
2025-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04400357 on ClinicalTrials.gov