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Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer

Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Laparoscopic pancreatoduodenectomy

Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Open pancreatoduodenectomy

Xianjun Yu, MD, PhD

Zheng Li, MD

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

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

Xiaowu Xu, M.D.

Xiaowu Xu, MD

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

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.

Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC

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

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

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

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.

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.

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.

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

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

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

The mortality within 90 days after surgery.

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

Fudan University

President of Fudan University Shanghai Cancer Center

Symptoms and General Pathology

Cysts

Pancreatic Cyst

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Laparoscopic, robot-assisted, or hybrid resection

Minimally invasive pancreatoduodenectomy

RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy (OPD). The generalizability of the current literature is, however, unknown since randomized studies are lacking, and current data are published from few, very high volume centers and selection bias with a lack of case-matched series. International studies are lacking completely.

OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in high-volume European pancreas centers (\>10 MIPDs per year, total \>20 PDs per year).

METHODS: A retrospective multicenter propensity-score matched cohort study including all consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic pancreatitis. Predefined electronic case report forms will be disseminated amongst participating centers. Participants are responsible for their own data collection. Matching of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch and German national registries) will be based on propensity scores determined by logistic regression including preoperative variables: year of surgery, demographics, BMI, ASA, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day postoperative events including: pancreatic fistula, length of hospital stay, R0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy and overall survival.

A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers

Outcomes After Minimally Invasive or Open Pancreatoduodenectomy in High-volume Centers; a Pan-European Retrospective Propensity-score Matched Cohort Study

Resection to adjuvant chemo(-radio) therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC	NCT04855331	Borderline Rese...	Laparoscopic pa... Open pancreatod...	18 Years - 80 Years	Fudan University
A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers	NCT03172572	Pancreatic Neop... Pancreas Cyst Pancreas Cancer	Minimally invas... Open pancreatod...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for open pancreatoduodenectomy