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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Minimally Invasive Surgery; Pancreatic Ductal Adenocarcinoma

Treatments: Procedure: open surgery; Procedure: robotic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04211948

HBP-RWR-001

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

robotic pancreatectomy

Experimental group

Description:

robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

Treatment:

Procedure: robotic surgery

open surgery

Active Comparator group

Description:

open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

Treatment:

Procedure: open surgery