1. Effect of multiple-phase regional intra-arterial infusion chemotherapy on patients with resectable pancreatic head adenocarcinoma JIN Chen, YAO Lie, LONG Jiang, FU De-liang, YU Xian- jun, XU Jin, YANG Feng, NI Quan-xing Pancreatic Disease Institution, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai 200040, China

2. Pancreatic Carcinoma Poor prognosis; overall 5-year survival rate <5% Cure: radical resection of tumor at an early – median survival time is rarely >12-18 months strong evidence that multimodality therapy could prolong the survival in patients w/ pancreatic CA Chemotherapy: a promising combined-modality therapy for pancreatic CA – Although tumor is relatively resistant to systemic chemotherapy

3. RIAC Regional intra-arterial infusion chemotherapy (RIAC) – More superior to systemic chemotherapy in improving prognosis and QOL in patients with inoperable pancreatic CA. Adjuvant RIAC in patients after pancreatic cancer resection could prolong the survival with low toxicity, and reduce the risk of liver metastasis. No evidence to prove the efficiency of pre-op or multiple-phase RIAC for patients with resectable pancreatic CA

4. Objectives To evaluate the effect and safety of multiple- phase RIAC in the combined-modality treatment for patients with pancreatic carcinoma Prospective cohort study: multiple-phase RIAC in patients with resectable pancreatic head CA after pancreaticoduodenectomy

5. In the Study… The effect of multiple-phase RIAC for patients with resectable pancreatic head adenocarcinoma was evaluated, and its safety and validity comparing with postoperative RIAC were also assessed

6. Patients Jan 2000-Dec 2006, px w/ resectable pancreatic head carcinoma undergoing extended pancreaticoduodenectomy in Pancreatic Disease Institute, Department of Surgery, Huashan Hospital, Fudan University were enrolled in the study. All patients were diagnosed by serum tumor markers such as CA19-9, CA50, CA125 and CA242, multi-detector row helical computed tomography (MDCT), and/or nuclear magnetic resonance imaging (MRI).

7. Patients Good function of the heart, liver and kidney Routine blood test: normal No history of prior chemoradiotherapy Px w/ obstructive jaundice at initial presentation received endoscopic palliation (biliary plastic stent) for the restoration of liver function or a total bilirubin level <50 µmol/L before they were enrolled.

8. Inclusion Criteria 25–75 y/o Resectable pancreatic head cancer; tumor stage II or III (according to International Union against Cancer 2002) without adjacent vascular invasion judged by CT or MR Reconfirmed diagnosis by histologically proven adenocarcinoma of the pancreas normal liver function no prior cancer therapy Karnofsky performance score (KPS) >60, expected survival >3 mos

9. Exclusion Criteria not histologically proven adenocarcinoma of the pancreas unresectable tumors or distant metastasis surgical procedure without radical resection of the tumor any condition not allowed to continue the protocol withdrawal requirements from the patients.

10. Methods Eligible patients were randomized into two groups: – grp A: treated with extended pancreaticoduodenectomy combined with multiple-phase RIAC – grp B: treated with extended pancreaticoduodenectomy combined with postoperative RIAC only Randomization was done using random numbers generated from a computer in a central registry for this study. Written informed consent was obtained from each patient, and the research protocol was approved by the Ethical Committee of Huashan Hospital, Fudan University, China.

11. Operative Criteria for Tumor Resection (1) absence of liver metastases (2) no peritoneal dissemination or drop metastases in the pelvis (3) lack of invasion of the transverse mesocolon (4) absence of metastases to the celiac lymph node (5) no involvement of the superior mesenteric artery, celiac artery, or common hepatic artery (6) the ability to obtain adequate vascular control of the superior mesenteric vein/portal vein, splenic vein, and inferior mesenteric veins for a safe venous reconstruction