Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer(a randomized, double-blind, multi-center, placebo-controlled study)

Phase 3

• Conditions: Primary or metastatic liver cancer

• Registration Number: JPRN-UMIN000003103
• Lead Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) PS(ECOG Performance Status Scale):0-2
2) Patients who is able to have oral intake of the test drugs
3) Age: 20 years or older
4) Gender: no specification
5) 4weeks or more blank after therapy is needed in case of receiving chemotherapy or radiotherapy in the prior treatment
6) Adequate organ functions and operable patient
7) CRP <= 2mg/dL
8) Inpatient/Outpatient: Inpatient(study duration)
9) Patients who can provide written informed consent

Exclusion Criteria

1) Patients who are scheduled to undergo laparoscopic hepatectomy
2) Patients with history of hepatectomy
3) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case)
4) Patients requiring emergency surgery
5) Patients with synchronous or metachronous gastric resection
6) Patients with synchronous colon resection
7) RFA in the remnant liver at the same time as excising hepatectomy
8) Patients with history of chemotherapy or radiotherapy within4weeks before surgery , history of perioperative chemotherapy or radiotherapy
9) Patients who are scheduled to undergo chemotherapy or radiotherapy within 10days after surgery
10) Patients who are administered another Kanpo medicines for medical treatment within 4weeks before the test drug administration
11) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
12) Patients undergoing biliary reconstruction
13) Patients who have a colostomy
14) Patients with history of resection of digestive canal
15) Constitutional selective defect in the hepatic transport of indocyanine green (ICG) ;Patients who are ICG intolerant
16) Synbiotics combination
17) Others, patients who are unfit for the study as determined by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified