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

NCT ID: NCT01607307

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-08-31

Brief 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.

Detailed 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).

Conditions

Paralytic Ileus

Keywords

daikenchuto; postoperative ileus; pancreaticoduodenectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Oral/enteral TJ-100 solution

Oral/enteral TJ-100 solution

Group Type: ACTIVE_COMPARATOR

Oral/enteral TJ-100 solution

Intervention Type: DRUG

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 solution

Oral/enteral placebo solution

Group Type: PLACEBO_COMPARATOR

Oral/enteral placebo solution

Intervention Type: DRUG

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.

Interventions

Oral/enteral TJ-100 solution

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.

Intervention Type: DRUG

Oral/enteral placebo solution

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.

Intervention Type: DRUG

Other Intervention Names

A; B

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epidemiological and Clinical Research Information Network

OTHER

Sponsor Role: collaborator

Wakayama Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hiroki Yamaue

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Second Department of Surgery, Wakayama Medical University

Locations

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

Wakayama, Wakayama, Japan

Countries

Japan

References

Maeda H, Okada KI, Fujii T, Oba MS, Kawai M, Hirono S, Kodera Y, Sho M, Akahori T, Shimizu Y, Ambo Y, Kondo N, Murakami Y, Ohuchida J, Eguchi H, Nagano H, Sakamoto J, Yamaue H. Transition of serum cytokines following pancreaticoduodenectomy: A subsidiary study of JAPAN-PD. Oncol Lett. 2018 Nov;16(5):6847-6853. doi: 10.3892/ol.2018.9422. Epub 2018 Sep 7.

Reference Type: DERIVED

PMID: 30333892 (View on PubMed)

Okada K, Kawai M, Hirono S, Fujii T, Kodera Y, Sho M, Nakajima Y, Satoi S, Kwon AH, Shimizu Y, Ambo Y, Kondo N, Murakami Y, Ohuchida J, Eguchi H, Nagano H, Oba MS, Morita S, Sakamoto J, Yamaue H; JAPAN-PD Investigators. Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial. Surgery. 2016 May;159(5):1333-41. doi: 10.1016/j.surg.2015.11.019. Epub 2015 Dec 31.

Reference Type: DERIVED

PMID: 26747224 (View on PubMed)

Other Identifiers

UMIN000007975

Identifier Type: OTHER

Identifier Source: secondary_id

JAPAN-PD

Identifier Type: -

Identifier Source: org_study_id