Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC

May 8, 2023 updated by: Xian-Jun Yu, Fudan University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
        • Sub-Investigator:
          • Xiaowu Xu, M.D.
        • Contact:
        • Principal Investigator:
          • Xianjun Yu, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic pancreatoduodenectomy
Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer
Procedure: 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
Procedure: Open pancreatoduodenectomy
Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 90 days after the surgery
The specific postoperative complications of pancreatic surgery include postoperative pancreatic fistula, postoperative hemorrhage and gastroparesis. Other common postoperative complications include abdominal infection, incision nonunion and so on. The degree of complications was evaluated by Clavien-Dindo grading system.
90 days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 90 days after the surgery
The length of hospital stay from the end of surgery to discharge or death. The length of hospital stay for readmission after discharge is not included.
90 days after the surgery
Operation time
Time Frame: 1 day
The time from the beginning to the end of the surgery.
1 day
R0 resection rate
Time Frame: 30 days after the surgery
Postoperative pathology confirmed that there were no tumor cells in the tissue within 1 mm from the surgical margin.
30 days after the surgery
The 90 days mortality rate after operation
Time Frame: 90 days after the surgery
The mortality within 90 days after surgery.
90 days after the surgery
The 90 days readmission rate
Time Frame: 90 days after the surgery
The rate of rehospitalization within 90 days after surgery due to aggravation.
90 days after the surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: up to 5 years after the surgery
The time from surgery until tumor recurrence, death or the last follow-up time.
up to 5 years after the surgery
Overall survival
Time Frame: up to 5 years after the surgery
The time from surgery until death or the last follow-up time.
up to 5 years after the surgery
Postoperative quality of life
Time Frame: up to 5 years after the surgery
Postoperative quality of life was assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale QLQ-C30 and pancreatic cancer quality of life specific scale QLQ-PAN26.
up to 5 years after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

West China Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Zhejiang Provincial People's Hospital
Fujian Provincial Hospital
The Third Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Xianjun Yu, MD, PhD, Fudan University
  • Study Director: Xiaowu Xu, MD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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