Divestment for Artery-involved Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival. Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression. Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.

Intervention public domain (ClinicalTrials.gov)

Procedure: Artery Divestment Technique. Tunica adventitia was pick up by forceps and opened by electrocoagulation at 1 cm distal from tumor-artery contact. Space between tunica adventitia and external elastic lamina (EEL) were blunt lifting tumor-invaded adventitia by angled clamp. Adventitia was then sectioned to show EEL. Loose dissect space could be achieve along long the plane between EEL and adventitia as long as tumor invasion outside EEL. Tumor and invaded adventitia were further cut open by electrocoagulation proximally. Circumferentially, separation could be done by blunt dissection around EEL. Nourishing blood vessels of the artery would be secured by electrocoagulation or ultrasonic scalpel while major branch would be ligated or transfixed.

Intervention public domain (ClinicalTrials.gov)

Drug: Nab-paclitaxel. After eligibility testing as blood tests, contrast-enhanced CT and MRI scan, 3 cycles were administered (1,000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel on days 1, 8, and 15 every 28 days).Patients will be reevaluated and curative operation would be attempted if without disease progression.

Arm public domain (ClinicalTrials.gov)

Surgery Group (experimental): In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status.

Arm public domain (ClinicalTrials.gov)

NeoChemo Group (active comparator): In NeoChemo (Neoadjuvant Chemotherapy) Group, neoadjuvant chemotherapy will be utilized. After 2 circles of neoadjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.

Primary outcome public domain (ClinicalTrials.gov)

Overall mortality at one year after randomization;. Time frame: 1 year.

Secondary outcome public domain (ClinicalTrials.gov)

Overall survival rate after 2 years from randomization;. Time frame: 2 years.

Secondary outcome public domain (ClinicalTrials.gov)

Overall survival rate after 3 years from randomization;. Time frame: 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Median survival. Time frame: 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Disease-free survival. Time frame: 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Margin status of subjects receiving curative surgery. Time frame: 1 years.

Secondary outcome public domain (ClinicalTrials.gov)

Intra-operative blood transfusion. Time frame: 1 years.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: 1. Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT\&MRI scan and tumor markers; 2. Age \> 18 year and \<80 year; 3. Agree to participate in the study with signed informed consent. Exclusion Criteria: 1. Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI; 2. Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy; 3. Focal vessel narrowing or contour irregularity revealed by radiology examinations; 4. Economic situations cannot afford designed treatment.

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 122 participants (estimated).