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Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC

Primary Purpose

Borderline Resectable Pancreatic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Laparoscopic pancreatoduodenectomy

Open pancreatoduodenectomy

About this trial

This is an interventional treatment trial for Borderline Resectable Pancreatic Cancer focused on measuring Pancreatic Ductal Adenocarcinoma, Neoadjuvant Chemotherapy, Laparoscopic Pancreatoduodenectomy, Safety and Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, borderline resectable pancreatic cancer (BRPC) with good physical condition, and locally advanced pancreatic cancer (LAPC) with tolerable general condition;
Receive at least 2 cycles of neoadjuvant chemotherapy before radical surgery；
After neoadjuvant chemotherapy, the patient can be further treated by minimally invasive 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 in RPC or BRPC patients during neoadjuvant chemotherapy. After neoadjuvant chemotherapy, LAPC patients failed reach the standard of minimally invasive surgery.

Sites / Locations

Department of Pancreatic Surgery, Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic pancreatoduodenectomy

Open pancreatoduodenectomy

Arm Description

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Outcomes

Primary Outcome Measures

Postoperative complications

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.

Secondary Outcome Measures

Length of stay

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.

Operation time

The time from the beginning to the end of the surgery.

R0 resection rate

Postoperative pathology confirmed that there were no tumor cells in the tissue within 1 mm from the surgical margin.

The 90 days readmission rate

The rate of rehospitalization within 90 days after surgery due to aggravation.

The 90 days mortality rate after operation

The mortality within 90 days after surgery.

Full Information

NCT ID

NCT04855331

First Posted

April 20, 2021

Last Updated

May 8, 2023

Sponsor

Fudan University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04855331

Brief Title

Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Resectable Pancreatic Cancer

Keywords

Pancreatic Ductal Adenocarcinoma, Neoadjuvant Chemotherapy, Laparoscopic Pancreatoduodenectomy, Safety and Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic pancreatoduodenectomy

Arm Type

Experimental

Arm Description

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Arm Title

Open pancreatoduodenectomy

Arm Type

Active Comparator

Arm Description

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic pancreatoduodenectomy

Intervention Description

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Intervention Type

Procedure

Intervention Name(s)

Open pancreatoduodenectomy

Intervention Description

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Primary Outcome Measure Information:

Title

Postoperative complications

Description

Time Frame

90 days after the surgery

Secondary Outcome Measure Information:

Title

Length of stay

Description

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.

Time Frame

90 days after the surgery

Title

Operation time

Description

The time from the beginning to the end of the surgery.

Time Frame

1 day

Title

R0 resection rate

Description

Postoperative pathology confirmed that there were no tumor cells in the tissue within 1 mm from the surgical margin.

Time Frame

30 days after the surgery

Title

The 90 days readmission rate

Description

The rate of rehospitalization within 90 days after surgery due to aggravation.

Time Frame

90 days after the surgery

Title

The 90 days mortality rate after operation

Description

The mortality within 90 days after surgery.

Time Frame

90 days after the surgery

Other Pre-specified Outcome Measures:

Title

Recurrence free survival

Description

The time from surgery until tumor recurrence, death or the last follow-up time.

Time Frame

up to 5 years after the surgery

Title

Overall survival

Description

The time from surgery until death or the last follow-up time.

Time Frame

up to 5 years after the surgery

Title

Postoperative quality of life

Description

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.

Time Frame

up to 5 years after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xianjun Yu, MD, PhD

Phone

+86-13801669875

yuxianjun@fudanpci.org

First Name & Middle Initial & Last Name or Official Title & Degree

Zheng Li, MD

Phone

+86-18521097686

lizheng@fudanpci.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xianjun Yu, MD, PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaowu Xu, MD

Organizational Affiliation

Fudan University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

+86-21-6417-5590

yuxianjun@fudanpci.org

First Name & Middle Initial & Last Name & Degree

Xianjun Yu, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Xiaowu Xu, M.D.

12. IPD Sharing Statement

Plan to Share IPD

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Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC

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