Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy

Wakayama Medical University220 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

220

Conditions

Paralytic Ileus

Interventions

Oral/enteral TJ-100 solutionDRUG

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.

Oral/enteral placebo solutionDRUG

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (5)

Nagoya University

Nagoya, Aichi-ken, Japan

Hiroshima University

Hiroshima, Hiroshima, Japan

Osaka University

Suita, Osaka, Japan

Shizuoka Cancer Center Hospital

Shizuoka, Shizuoka, Japan

Wakayama Medical University

Outcomes

Primary Outcomes

Incidence of postoperative paralytic ileus (including the duration of paralysis)

Delayed passage of first flatus for 72 hours (3.0 days) after surgery, or a postoperative condition that requires an intervention for the ileus. Every 12 hours is counted as 0.5 postoperative day and every 24 hours as 1.0 postoperative day.

Time frame: 72 hours

The duration until the first flatus after surgery.

The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.

Time frame: 14 days

Secondary Outcomes

QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)

QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) on postoperative day 7.

Time frame: 7 days

Abdominal pain and abdominal distention scores on the Visual Analogue Scale.

Abdominal pain and abdominal distention scores on the Visual Analogue Scale on postoperative day 3.

Time frame: 3 days

The change ratio of abdominal circumference.

The change ratio of abdominal circumference on postoperative day 3 and operative day just after surgery

Time frame: 3 days

The incidence of postoperative complication.

The incidence of postoperative complication based on Dindo's classification.

Time frame: 14 days

The length of postoperative hospital day.

Patients were discharged only when they fulfilled the criteria as follows: a return to preoperative activities of daily living, no deep-site infections, normal laboratory data, no drains, and the possibility for oral nutrition above the basal metabolism.

Data from ClinicalTrials.gov

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