Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer: An Multicenter Open-label Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to evaluate the safety and efficacy of laparoscopic versus open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Before neoadjuvant chemotherapy, pancreatic ductal adenocarcinoma was confirmed by pathology;

• According to the guidelines, neoadjuvant chemotherapy should be performed before surgery, including patients with resectable pancreatic cancer (RPC) with high risk factors (biologically borderline resectable), anatomically borderline resectable pancreatic cancer (BRPC) with good physical condition;

• Receive at least 2 cycles of neoadjuvant chemotherapy before radical surgery;

• After neoadjuvant chemotherapy, the patient can be further treated by laparoscopic or open surgery;

• No obvious surgical contraindications, suitable for minimally invasive surgery;

• ECOG score of preoperative physical condition was 0-1;

• No history of preoperative pancreatitis;

• Preoperative PET-CT or other imaging examination did not show distant metastasis;

• The expected postoperative survival time was more than 3 months;

• Be able to comply with research protocol, follow-up plan and other protocol requirements;

• Voluntary participation and signed informed consent.

Locations
Other Locations
China
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xianjun Yu, MD, PhD
yuxianjun@fudanpci.org
+86-13801669875
Backup
Zheng Li, MD
lizheng@fudanpci.org
+86-18521097686
Time Frame
Start Date: 2021-04-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 120
Treatments
Experimental: Laparoscopic pancreatoduodenectomy
Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer
Active_comparator: Open pancreatoduodenectomy
Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer
Sponsors
Collaborators: Fujian Provincial Hospital, Qilu Hospital of Shandong University, West China Hospital, The Third Affiliated Hospital of Soochow University, Tongji Hospital, Zhejiang Provincial People's Hospital
Leads: Fudan University

This content was sourced from clinicaltrials.gov