Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer

NCT04211948 | Unknown

• 1 other identifier: HBP-RWR-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.

Conditions

Pancreatic Ductal Adenocarcinoma; Minimally Invasive Surgery

Keywords

Robotic assisted surgery

Outcome Measures

Primary Outcomes (2)

• 1 year overall survival rate

  1 year post-operation

• 3 years overall survival rate

  3 years post-operation

Secondary Outcomes (2)

• Postoperative Complications

  Within 90 days or before discharge

• 1, 3years disease free survival rate

  1,3years post-operation

Study Arms (2)

robotic pancreatectomy

EXPERIMENTAL

robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

Procedure: robotic surgery

open surgery

ACTIVE COMPARATOR

open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

Procedure: open surgery

Interventions

robotic surgery PROCEDURE

Pancreatectomy with robotic assisted system

robotic pancreatectomy

open surgery PROCEDURE

Traditional open pancreatectomy

open surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed pancreatic ductal adenocarcinoma
• Patients and their families volunteered to test and signed informed consent.

You may not qualify if:

• Patients with metastasis (M1)
• Patients with tumor recurrence
• Patients with artery and/or vein invasion and can't perform radical resection and reconstruction
• Patients with poor cardiopulmonary function cannot tolerate surgery;
• receive neoadjuvant radiotherapy and chemotherapy before surgery;
• The patient or family member refuses to join the group;
• Pregnant patients
• Intraoperative exploration of metastases in other parts besides the primary lesion
• Other organs malignant tumors metastasize to the pancreas
• pathology confirmed non-pancreatic ductal adenocarcinoma

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Robotic Surgical Procedures; Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Kai Qin

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Qin, Doctor

CONTACT

0086-(0)21-64370045; qinkai310@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 26, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)