Clinical Trials Logo
  1. Home
  2. Bile Duct Cancer
  3. NCT01256047
  4. Details
NCT01256047 Clinical Trial

Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

Bile Duct Cancer Clinical Trial

Official title:
Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01256047
Other study ID # furukawa2009-2
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2009
Est. completion date March 2014

Study information
Verified date February 2020
Source Chiba University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.

Description:

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- hepatectomy

Exclusion Criteria:

- age younger than 18 years

- ongoing infection

- gastrointestinal obstruction

- respiratory dysfunction

- cardiac dysfunction

- hepatic dysfunction

- renal failure

- history of recent immunosuppressive or immunological disease

- preoperative evidence of widespread metastatic disease

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral IMPACT
oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

Locations
Country Name City State
Japan Chiba University Chiba

Sponsors (1)
Lead Sponsor Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative infectious complication 30 days
Secondary plasma IL-6, CRP, Th1/Th2 balance 14 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT02954302 - Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy N/A
Active, not recruiting NCT01954745 - A Phase II Study of Cabozantinib (XL-184) Monotherapy in Patients With Advanced Cholangiocarcinoma After Progression on First or Second Line Systemic Therapy Phase 2
Recruiting NCT01439698 - Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry N/A
Active, not recruiting NCT04164069 - Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab Phase 1
Recruiting NCT05155878 - Prognostic Factors in Periampullary Tumors and Cysts
Recruiting NCT04993131 - Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma N/A
Active, not recruiting NCT05662488 - FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
Completed NCT05266300 - Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Active, not recruiting NCT04853017 - A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Phase 1
Recruiting NCT05286814 - M9241 in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer or Intrahepatic Cholangiocarcinoma Phase 2
Completed NCT02853474 - Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy Phase 3
Completed NCT00639314 - Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy N/A
Completed NCT04596865 - Recurrence After Whipple's (RAW) Study
Recruiting NCT05277766 - Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer Phase 1
Recruiting NCT01522573 - T-EUS for Gastrointestinal Disorders: A Multicenter Registry N/A
Enrolling by invitation NCT01111591 - Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer Phase 4
Completed NCT00779688 - A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers N/A
Active, not recruiting NCT04152018 - Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. Phase 1