Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC

NCT04855331 | Unknown DMC

• 1 other identifier: CSPAC-5
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Borderline Resectable Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days after the surgery

Secondary Outcomes (5)

• Length of stay

  90 days after the surgery

• Operation time

  1 day

• R0 resection rate

  30 days after the surgery

• The 90 days readmission rate

  90 days after the surgery

• The 90 days mortality rate after operation

  90 days after the surgery

Other Outcomes (3)

• Recurrence free survival

  up to 5 years after the surgery

• Overall survival

  up to 5 years after the surgery

• Postoperative quality of life

  up to 5 years after the surgery

Study Arms (2)

Laparoscopic pancreatoduodenectomy

EXPERIMENTAL

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Procedure: Laparoscopic pancreatoduodenectomy

Open pancreatoduodenectomy

ACTIVE COMPARATOR

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Procedure: Open pancreatoduodenectomy

Interventions

Laparoscopic pancreatoduodenectomy PROCEDURE

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Laparoscopic pancreatoduodenectomy

Open pancreatoduodenectomy PROCEDURE

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Open pancreatoduodenectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• The Third Affiliated Hospital of Soochow University: collaborator
• Qilu Hospital of Shandong University: collaborator
• West China Hospital: collaborator
• Tongji Hospital: collaborator
• Fujian Provincial Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (13)

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  PMID: 30080726 BACKGROUND

• Croome KP, Farnell MB, Que FG, Reid-Lombardo KM, Truty MJ, Nagorney DM, Kendrick ML. Total laparoscopic pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: oncologic advantages over open approaches? Ann Surg. 2014 Oct;260(4):633-8; discussion 638-40. doi: 10.1097/SLA.0000000000000937.

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Study Officials

• Xianjun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaowu Xu, MD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Xianjun Yu, MD, PhD

CONTACT

+86-13801669875; yuxianjun@fudanpci.org

Zheng Li, MD

CONTACT

+86-18521097686; lizheng@fudanpci.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: April 15, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)