Clinical trial NCT01607307: Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Paralytic Ileus
Keywords: daikenchuto
postoperative ileus
pancreaticoduodenectomy
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
Collaborators: name: Epidemiological and Clinical Research Information Network
First posted: 2012-05-30
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Incidence of postoperative paralytic ileus (including the duration of paralysis)
timeFrame: 72 hours
measure: The duration until the first flatus after surgery.
timeFrame: 14 days
Secondary outcomes:
measure: QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)
timeFrame: 7 days
measure: Abdominal pain and abdominal distention scores on the Visual Analogue Scale.
timeFrame: 3 days
measure: The change ratio of abdominal circumference.
timeFrame: 3 days
measure: The incidence of postoperative complication.
timeFrame: 14 days
measure: The length of postoperative hospital day.
timeFrame: 30 days
measure: The incidence of surgical site infection.
timeFrame: 30 days
measure: The long term incidence of postoperative ileus after surgery.
timeFrame: 2 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University
state: Aichi
city: Suita
country: Japan
facility: Osaka University
state: Osaka
city: Hiroshima
country: Japan
facility: Hiroshima University
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
affiliation: Second Department of Surgery, Wakayama Medical University
name: Hiroki Yamaue, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.