Comparing laparoscopic and open surgery for pancreatic cancer after chemotherapy

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

This study is testing whether a less invasive surgery for pancreatic cancer after chemotherapy can help patients recover better and live longer compared to traditional open surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04855331 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of laparoscopic versus open pancreatoduodenectomy in patients with borderline resectable pancreatic cancer who have undergone neoadjuvant chemotherapy. It aims to determine if minimally invasive surgery can provide similar or better outcomes compared to traditional open surgery, particularly in terms of recovery and survival rates. The study is based on the premise that neoadjuvant therapy can improve surgical outcomes by reducing tumor size and improving resectability. Participants will be monitored for postoperative complications and overall survival.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with borderline resectable pancreatic ductal adenocarcinoma who have received at least two cycles of neoadjuvant chemotherapy.

Not a fit: Patients with distant metastasis or those who are not suitable for surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with borderline resectable pancreatic cancer.

How similar studies have performed: Previous studies have shown promising results for minimally invasive approaches in pancreatic surgery, suggesting this study builds on established findings.

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.

Where this trial is running

Shanghai, Shanghai

• Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Xianjun Yu, MD, PhD — Fudan University
• Study coordinator: Xianjun Yu, MD, PhD

Conditions: Borderline Resectable Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Neoadjuvant Chemotherapy, Laparoscopic Pancreatoduodenectomy, Safety and Efficacy