Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC

NCT ID: NCT04855331

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2025-12-31

Brief 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

Detailed Description

Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive tumors with an increasing incidence and constitutes the fourth leading cause of cancer-related deaths. Radical resection remains the potential curative treatments for selected patients, and the Miami international evidence-based guidelines suggest that minimally invasive resection is feasible, safe, and oncologically equivalent for PDAC patients compared with open surgery. Furthermore, minimally invasive pancreatomy was associated with better overall and disease-free survival.

However, only 15% to 20% PDAC patients are eligible for upfront surgery at the time of initial diagnosis. For borderline resectable PDAC, studies have confirmed that neoadjuvant therapy can provide more oncological benefits than upfront surgery, such as improved rates of margin-negative resection and decreased incidence of lymph node metastases. Additionally, short-term neoadjuvant therapy has been shown to improve postoperative survival. These findings support the use of short-term neoadjuvant therapy in borderline resectable PDACs, as recommended by the National Comprehensive Cancer Network guidelines.

Neoadjuvant therapy can lead to severe fibrosis in the localized tumor tissue, which may hinder dissection and increase the risk of dangerous and bloody surgery. Furthermore, most anatomically borderline resectable PDACs have a large diameter and are in close proximity to major blood vessels, making the surgical procedure more complex and challenging. To date, there is insufficient evidence to determine the feasibility and safety of minimally invasive pancreatectomy compared to open surgery after neoadjuvant therapy.

This study aims to evaluate the safety and efficacy of laparoscopic pancreatoduodenectomy (LPD) versus open pancreatoduodenectomy (OPD) for borderline resectable PDAC following neoadjuvant chemotherapy (NACT) through a multicenter randomized controlled clinical trial.

Conditions

Borderline Resectable Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic pancreatoduodenectomy

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Group Type: EXPERIMENTAL

Laparoscopic pancreatoduodenectomy

Intervention Type: PROCEDURE

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Open pancreatoduodenectomy

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Group Type: ACTIVE_COMPARATOR

Open pancreatoduodenectomy

Intervention Type: PROCEDURE

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Interventions

Laparoscopic pancreatoduodenectomy

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Intervention Type: PROCEDURE

Open pancreatoduodenectomy

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Neoadjuvant chemotherapy is not suitable before operation according to the guidelines;
• Invasion of adjacent organs, abdominal cavity or distant metastasis was found by introperative exploration;
• Patients requiring total pancreatectomy;
• Severe impairment of heart, liver and kidney function;
• Patients with other malignancies or hematological diseases;
• The patient is pregnant, planning to be pregnant or lactating；
• Before surgery, anti-cancer therapy except neoadjuvant chemotherapy were performed, including interventional chemoembolization, ablation, radiotherapy and molecular targeted therapy;
• Participants in other clinical trials;
• Tumor progression occurred during neoadjuvant chemotherapy. After neoadjuvant chemotherapy, patients failed reach the standard of laparoscopic surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

President of Fudan University Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianjun Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Xiaowu Xu, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xianjun Yu, MD, PhD

Role: CONTACT

yuxianjun@fudanpci.org

+86-13801669875

Zheng Li, MD

Role: CONTACT

lizheng@fudanpci.org

+86-18521097686

Facility Contacts

XianJun Yu, M.D., Ph.D.

Role: primary

yuxianjun@fudanpci.org

+86-21-6417-5590

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Other Identifiers

CSPAC-5

Identifier Type: -

Identifier Source: org_study_id