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

Not Applicable

Recruiting

• Conditions: Minimally Invasive Surgery; Pancreatic Ductal Adenocarcinoma
• Interventions: Procedure: robotic surgery; Procedure: open surgery

• Registration Number: NCT04211948
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-26
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-09
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Preoperative exclusion:

  1. Patients with metastasis (M1)
  2. Patients with tumor recurrence
  3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction
  4. Patients with poor cardiopulmonary function cannot tolerate surgery;
  5. receive neoadjuvant radiotherapy and chemotherapy before surgery;
  6. The patient or family member refuses to join the group;
  7. Pregnant patients

• Intraoperative exclusion:

  1. Intraoperative exploration of metastases in other parts besides the primary lesion
  2. Other organs malignant tumors metastasize to the pancreas

• Postoperative exclusion:

  1. pathology confirmed non-pancreatic ductal adenocarcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic pancreatectomy	robotic surgery	robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)
open surgery	open surgery	open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

Primary Outcome Measures

Name	Time	Method
3 years overall survival rate	3 years post-operation
1 year overall survival rate	1 year post-operation

Secondary Outcome Measures

Name	Time	Method
Postoperative Complications	Within 90 days or before discharge	pancreatic fistula, bile leakage, hemorrhage, DGE, etc
1, 3years disease free survival rate	1,3years post-operation

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China