UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Daikenchuto on Postoperative Bowel Motility and on Prevention of Paralytic Ileus after Pancreaticoduodenectomy A Multicenter, Randomized, Placebo-controlled Phase II trial
Title of the study (Brief title)	The JAPAN-PD Study
Region	Japan

Condition
Condition	The 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 pancreas who are expected to undergo pancreaticoduodenectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate enhancement effect of the bowel motility and prevention effect of Daikenchuto (TJ-100) for postoperative paralytic ileus after pancreaticoduodenectomy.
Basic objectives2	Others
Basic objectives -Others	Cytokine concentration of serum and abdominal fluid on postoperative surgery.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The primary endpoints are the incidence of postoperative paralytic ileus and the duration until the first flatus after surgery.
Key secondary outcomes	The secondary endpoints are QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale about abdominal pain and abdominal distention, the change ratio of abdominal circumference on postoperative day 3 and operative day just after surgery, the incidence of postoperative complication, the length of postoperative hospital day, the incidence of surgical site infection and the incidence of postoperative small bowel obstruction within 2 years after surgery.

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ARM A In TJ-100 group, TJ-100 at a dose of 5 g was administered orally as a solution three times daily immediately before meals or every 8 h for 10 consecutive days (15 g/day from preoperative day 3 to postoperative day 7). On the operative day (only once immediately after operation) and postoperative day 1, TJ-100 were administered as a diluent via Argyle enteral feeding tube (10 Fr), which terminates in jejunum to prevent aspiration pneumonia.
Interventions/Control_2	ARM B In placebo group, placebo at a dose of 5 g was administered orally as a solution three times daily immediately before meals or every 8 h for 10 consecutive days (15 g/day from preoperative day 3 to postoperative day 7). On the operative day (only once immediately after operation) and postoperative day 1, placebo were administered as a diluent via Argyle enteral feeding tube (10 Fr), which terminates in jejunum to prevent aspiration pneumonia.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	i) 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. ii) Age of at least 20 years old at the time of registration. iii) All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria	i) Clinically problematic cardiac disease. ii) Liver cirrhosis or active hepatitis. iii) Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.). iv) Chronic renal failure requiring hemodialysis. v) Other malignant disease that can influence the adverse effect. vi) Patients with tumors requiring resection of colon. vii) Patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history. viii) Patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants. ix) Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration. x) Pregnant or lactating women. xi) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size	220

Research contact person
Name of lead principal investigator	Hiroki Yamaue
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0612
Email	yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person	Ken-ichi Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Homepage URL
Email	okada@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Research grant from a non-profit organization: Epidemiological and clinical Research Information Network (ECRIN).
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01607307
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 19 Day
Anticipated trial start date	2012 Year 08 Month 10 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2014 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 17 Day
Last modified on	2016 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000009376