Minimally Invasive Versus Open Radical Pancreatectomy After Neoadjuvant Chemotherapy for Pancreatic Cancer
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| ClinicalTrials.gov Identifier: NCT04855331 |
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Recruitment Status :
Recruiting
First Posted : April 22, 2021
Last Update Posted : September 10, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Procedure: Minimally invasive radical pancreatectomy Procedure: Open radical pancreatectomy | Not Applicable |
In recent years, the incidence of pancreatic ductal adenocarcinoma (PDAC) has been increasing in the world. It has become the fourth leading cause of cancer death, and seriously threatens human life. The surgical resection rate of PDAC is very low, only about 15% - 20% of the patients can receive surgical treatment at the first visit. But at present, surgical resection is still the only treatment that can make the PDAC patients survive for a relative long time. (CA Cancer J Clin. 2016;66(1):7) With the application of neoadjuvant chemotherapy in clinical practice, the treatment concept of PDAC has changed significantly. A growing number of studies show that neoadjuvant chemotherapy can significantly improve the radical resection (R0) rate of PDAC patients, and thus improve the prognosis (J Clin Oncol. 2017;35(5):515; J Surg Oncol. 2019;120(6):976). Currently, according to the latest edition of the National Comprehensive Cancer Network (NCCN) guidelines, 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, should receive neoadjuvant chemotherapy.
With the development of pancreatic surgery, the mortality has decreased from 30% to 3-5%. Minimally invasive technique has the advantages of less intraoperative bleeding, less postoperative pain, less postoperative complications and relatively high cost-effectiveness. In other abdominal tumors, such as gastric and colorectal cancer, minimally invasive technique has been recommended as the first choice for radical operation (Gastroenterol Res Pract, 2017,2017:9278469; Surg Clin North Am, 2017,97(3):54). Minimally invasive pancreatic surgery is mainly composed of minimally invasive pancreatoduodenectomy (MIPD) and minimally invasive distal pancreatectomy (MIDP). With the progress of surgical technique, especially the maturity of laparoscopic or robotic vascular resection and reconstruction, MIPD becomes safe and feasible, and has been carried out in large pancreatic surgery centers. On the other hand, MIDP is the main indication of minimally invasive pancreatic surgery because it does not need digestive tract reconstruction, has no complex anastomosis, and involves less large vessels. Compared with open pancreatic surgery, MIDP has the advantages of less intraoperative bleeding and faster postoperative recovery, and there was no significant difference in the incidence of pancreatic fistula, total complication rate and mortality (Ann Surg. 2019;269(1):2; Updates Surg. 2020;72(2):387).
Neoadjuvant chemotherapy can help to reduce tumor stage, alleviate vascular invasion, improve R0 resection rate, control tumor micro-metastasis and reduce tumor recurrence and metastasis risk. With the recommendations of clinical guidelines, patients with PDAC receiving neoadjuvant chemotherapy is increasing. For these patients, how to choose the further surgical strategy and whether minimally invasive surgery is safe and effective compared with open surgery have not been reported.
Therefore, we designed this multicenter randomized controlled trial to assess the safety and effectiveness of minimally invasive versus open radical pancreatectomy after neoadjuvant chemotherapy for PDAC. This study will provide high-level evidence-based medicine for the choice of surgical strategy for PDAC after neoadjuvant chemotherapy.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Minimally Invasive Versus Open Radical Pancreatectomy After Neoadjuvant Chemotherapy for Pancreatic Cancer: An Multicenter Open-label Randomized Clinical Trial |
| Actual Study Start Date : | May 13, 2021 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Minimally invasive radical pancreatectomy
After neoadjuvant chemotherapy, patients with pancreatic ductal adenocarcinoma underwent laparoscopic or robotic radical pancreatectomy.
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Procedure: Minimally invasive radical pancreatectomy
The tumor was completely removed by minimally invasive radical pancreatectomy. Routine lymph node dissection was performed and no tumor cells could be observed by microscope in the tissue within 1 mm from the resection margin (R0 resection). |
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Active Comparator: Open radical pancreatectomy
After neoadjuvant chemotherapy, patients with pancreatic ductal adenocarcinoma underwent open radical pancreatectomy.
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Procedure: Open radical pancreatectomy
The tumor was completely removed by minimally invasive radical pancreatectomy. Routine lymph node dissection was performed and no tumor cells could be observed by microscope in the tissue within 1 mm from the resection margin (R0 resection). |
- 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.
- 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.
- Operation time [ Time Frame: 1 day ]The time from the beginning to the end of the surgery.
- 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.
- The 30 days readmission rate [ Time Frame: 90 days after the surgery ]The rate of rehospitalization within 30 days after surgery due to aggravation.
- The 90 days mortality rate after operation [ Time Frame: 90 days after the surgery ]The mortality within 90 days after surgery.
- 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.
- Overall survival [ Time Frame: up to 5 years after the surgery ]The time from surgery until death or the last follow-up time.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855331
| Contact: Xianjun Yu, MD, PhD | +86-13801669875 | yuxianjun@fudanpci.org | |
| Contact: Zheng Li, MD | +86-18521097686 | reclusion@foxmail.com |
| China, Shanghai | |
| Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: XianJun Yu, M.D., Ph.D. +86-21-6417-5590 yuxianjun@fudanpci.org | |
| Principal Investigator: Xianjun Yu, M.D., Ph.D. | |
| Principal Investigator: | Xianjun Yu, MD, PhD | Fudan University |
| Responsible Party: | Xian-Jun Yu, President of Shanghai Pancreatic Cancer Institute, Fudan University |
| ClinicalTrials.gov Identifier: | NCT04855331 |
| Other Study ID Numbers: |
CSPAC-5 |
| First Posted: | April 22, 2021 Key Record Dates |
| Last Update Posted: | September 10, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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