Know Cancer

or
forgot password

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


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Paralytic Ileus

Thank you

Trial Information

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


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).


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

72 hours

Safety Issue:

Yes

Principal Investigator

Hiroki Yamaue, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Second Department of Surgery, Wakayama Medical University

Authority:

Japan: Institutional Review Board

Study ID:

JAPAN-PD

NCT ID:

NCT01607307

Start Date:

August 2012

Completion Date:

August 2016

Related Keywords:

  • Paralytic Ileus
  • daikenchuto
  • postoperative ileus
  • pancreaticoduodenectomy
  • Intestinal Pseudo-Obstruction
  • Ileus

Name

Location