Overview

This trial is active, not recruiting.

Condition paralytic ileus
Treatments oral/enteral tj-100 solution, oral/enteral placebo solution
Phase phase 2
Sponsor Wakayama Medical University
Collaborator Epidemiological and Clinical Research Information Network
Start date August 2012
End date December 2013
Trial size 220 participants
Trial identifier NCT01607307, JAPAN-PD, UMIN000007975

Summary

A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the prevention of postoperative paralytic ileus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
Oral/enteral TJ-100 solution
oral/enteral tj-100 solution A
Oral TJ-100 solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent TJ-100 solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.
(Placebo Comparator)
Oral/enteral placebo solution
oral/enteral placebo solution B
Oral placebo solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent placebo solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.

Primary Outcomes

Measure
Incidence of postoperative paralytic ileus (including the duration of paralysis)
time frame: 72 hours
The duration until the first flatus after surgery.
time frame: 14 days

Secondary Outcomes

Measure
QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)
time frame: 7 days
Abdominal pain and abdominal distention scores on the Visual Analogue Scale.
time frame: 3 days
The change ratio of abdominal circumference.
time frame: 3 days
The incidence of postoperative complication.
time frame: 14 days
The length of postoperative hospital day.
time frame: 30 days
The incidence of surgical site infection.
time frame: 30 days
The long term incidence of postoperative ileus after surgery.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Patients with periampullary tumors (extrahepatic bile duct tumor, tumors of ampulla of Vater and duodenal tumor) and pancreatic tumors (pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, pancreatic endocrine tumor and pancreatic neuroendocrine tumor) of the head of the pancreas who are scheduled to undergo PD. - Age of at least 20 years old at the time of registration. - All patients provided written informed consent before initiation of study-related procedures. Exclusion Criteria: - Clinically problematic cardiac disease. - Liver cirrhosis or active hepatitis. - Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.). - Chronic renal failure requiring hemodialysis. - Other malignant disease that can influence the adverse effect. - Patients with tumors requiring resection of colon. - Patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history. - Patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants. - Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration. - Pregnant or lactating women. - Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Additional Information

Official title Effect of Daikenchuto (TJ-100) on Intestinal Dysmotility and For the Prevention of Postoperative Paralytic Ileus in Patients Undergoing Pancreaticoduodenectomy: A Multicenter, Randomized, Placebo-Controlled Phase II Trial
Principal investigator Hiroki Yamaue, M.D., Ph.D.
Description Daikenchuto (TJ-100), a traditional Japanese herbal medicine, is used for prevention and treatment of postoperative ileus. TJ-100 extract powder (Tsumura & Co., Tokyo, Japan) is manufactured as an aqueous extract containing 2.2 % Japanese pepper, 5.6 % processed ginger, 3.3 % ginseng, and 88.9 % maltose syrup powder. A recent randomized, parallel-group, double-blind, placebo-controlled, dose-response trial demonstrated that TJ-100 accelerates colonic transit time, particularly in the ascending colon. Given its potential actions in the intestinal tract, it seems reasonable to postulate that TJ-100 may play a role in improving and preventing bowel dysmotility. This study was designed to investigate the effect of TJ-100 on intestinal dysmotility and for the prevention of postoperative paralytic ileus in patients undergoing pancreaticoduodenectomy. The primary endpoint is the incidence of postoperative paralytic ileus. Secondary endpoints are QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale, the change in ratio of abdominal circumference, the incidence of postoperative complications, the length of hospital day, and the incidence of surgical site infection. Two hundred patients are required for the study (100 patients per group).
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Wakayama Medical University.