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

Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04211948
Enrollment
300
Registered
2019-12-26
Start date
2019-03-01
Completion date
2024-12-31
Last updated
2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally Invasive Surgery, Pancreatic Ductal Adenocarcinoma

Keywords

Robotic assisted surgery

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.

Interventions

PROCEDURErobotic surgery

Pancreatectomy with robotic assisted system

PROCEDUREopen surgery

Traditional open pancreatectomy

Sponsors

Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
1 year overall survival rate1 year post-operation
3 years overall survival rate3 years post-operation

Secondary

MeasureTime frameDescription
Postoperative ComplicationsWithin 90 days or before dischargepancreatic fistula, bile leakage, hemorrhage, DGE, etc
1, 3years disease free survival rate1,3years post-operation

Countries

China

Contacts

Primary ContactKai Qin, Doctor
qinkai310@sina.com0086-(0)21-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026