Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO-HBP-005): Clinical Study Group of Osaka University, Hepato-Biliary-Pancreatic Group.

Aim: Neoadjuvant transcatheter arterial chemoembolization (TACE) for large tumors is controversial, especially in the minimally invasive surgery era. The aim of this study was to compare features between groups treated with neoadjuvant TACE followed by surgery (TACE + surgery) or upfront surgery for hepatocellular carcinoma >5 cm.

Methods: In this exploratory, multicenter, randomized phase I study, the primary measure was 2-year disease-free survival (DFS).

Preoperative risk score to predict subtotal cholecystectomy after gallbladder drainage for acute cholecystitis: Secondary analysis of data from a multi-institutional retrospective study (CSGO-HBP-017B).

Introduction: Subtotal cholecystectomy (STC) has become recognized as a "bailout procedure" to prevent bile duct injury in patients undergoing laparoscopic cholecystectomy (LC). Predictors of conversion to STC have not been identified because LC difficulty varies based on pericholecystic inflammation. We analyzed data from patients enrolled in a previously performed multi-institutional retrospective study of the optimal timing of LC after gallbladder drainage for acute cholecystitis (AC).

[Capecitabine and Oxaliplatin(CAPOX)plus Bevacizumab as Second-Line Chemotherapy for Metastatic Colorectal Cancer].

Objective: To evaluate the efficacy and safety of CAPOX plus bevacizumab as second-line chemotherapy for metastatic colorectal cancer.

Methods: In this multicenter phase Ⅱ study, the planned number of patients was 48, but owing to poor case accumulation, registration was discontinued for 20 patients. The primary endpoint was the response rate(RR).

Randomized clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy regarding incidence of delayed gastric emptying after pancreaticoduodenectomy.

Purpose: Delayed gastric emptying (DGE) is an important postoperative complication after pancreaticoduodenectomy (PD), and its incidence may be associated with the utilized surgical procedures. Compared with pancreaticojejunostomy (PJ) after PD, it may be speculated that pancreaticogastrostomy (PG) is a risk factor for DGE, because it needs an anastomosis of the remnant pancreas to the back wall of the stomach. This study aimed to compare PG and PJ with regard to the incidence of DGE after PD.

Optimal timing of laparoscopic cholecystectomy after gallbladder drainage for acute cholecystitis: A multi-institutional retrospective study.

Background: There is no consensus on the optimal timing of laparoscopic cholecystectomy (LC) after gallbladder drainage for acute cholecystitis (AC). To obtain evidence for a consensus, we investigated surgical outcomes of LC after gallbladder drainage with respect to the time elapsed from gallbladder drainage to surgery in a multi-institutional retrospective study.

Methods: This study enrolled 347 patients who underwent LC after gallbladder drainage for AC at 15 institutions.

Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study.

Background: Preoperative 5-FU-based chemoradiation is currently a standard treatment for advanced rectal cancer, particularly in Western countries. Although it reduced the local recurrence, it could not necessarily improve overall survival. Furthermore, it can also produce adverse effects and long-term sphincter function deficiency.

A Prospective, Open-Label, Multicenter Phase 2 Trial of Neoadjuvant Therapy Using Full-Dose Gemcitabine and S-1 Concurrent with Radiation for Resectable Pancreatic Ductal Adenocarcinoma.

Background: Neoadjuvant therapy reportedly shows only marginal clinical benefit in pancreatic ductal adenocarcinoma (PDAC), especially in resectable cases. However, with more effective regimens, neoadjuvant therapy may become a standard of care for resectable cases. A prospective, open-label, multicenter phases 1 and 2 trial of neoadjuvant therapy was conducted using full-dose gemcitabine and S-1 concurrently with 50.

A Prospective, Multi-Center Phase I Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies.

Background: Venous thromboembolism (VTE) is one of the critical complications that can occur after surgery. A positive association between cancer and VTE risk is well established; however, the safety and efficacy of VTE prophylaxis have not been established in hepatobiliary-pancreatic surgery, especially in surgery for malignancies.

Methods: A prospective, multi-center Phase I study to determine the safety of enoxaparin was performed.

Survival outcomes of appendiceal mucinous neoplasms by histological type and stage: Analysis of 266 cases in a multicenter collaborative retrospective clinical study.

Aim: Appendiceal mucinous neoplasms are rare, and thus the literature is sparse with regard to histological types, staging, and prognosis. In particular, it is unclear how long-term outcome may differ between mucinous adenocarcinomas and other adenocarcinomas. In the present study, we aimed to investigate the histological types and stages of appendiceal neoplasms, and to evaluate the prognostic impacts of these factors in patients with mucinous adenocarcinomas and non-mucinous adenocarcinomas.

Phase I/II study of bi-weekly XELIRI plus bevacizumab treatment in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy.

Purpose: We aimed to determine the recommended dose for bi-weekly XELIRI plus bevacizumab for second-line chemotherapy and examined its safety and efficacy in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy.

Methods: Irinotecan and bevacizumab were administered as a continuous intravenous infusion on Day 1 at 150 mg/mm and 5 mg/kg, respectively. Capecitabine was orally administered in two divided doses on Days 2-8.

The effects of chemotherapy on primary small bowel cancer: A retrospective multicenter observational study in Japan.

Small bowel cancer is relatively rare among gastrointestinal tract cancers, including esophageal, gastric and colorectal cancers. The majority of cases of small bowel cancer are diagnosed at an advanced stage, resulting in poor outcomes. The clinical effects of chemotherapy on small bowel cancer have been investigated in a limited number of studies from Europe and the USA.

Neoadjuvant capecitabine and oxaliplatin (XELOX) combined with bevacizumab for high-risk localized rectal cancer.

Purpose: Chemoradiotherapy followed by total mesorectal excision (TME) is the standard treatment for locally advanced rectal cancer. Although this approach decreases the risk of local recurrence, pelvic radiation is associated with long-term morbidity and delays systemic treatment. We conducted this study to evaluate the feasibility of neoadjuvant capecitabine and oxaliplatin (XELOX) plus bevacizumab as a treatment for high-risk localized rectal cancer.