UMIN-CTR Clinical Trial

Public title

Effect of Daikenchuto on Postoperative Bowel Motility and on Prevention of Paralytic Ileus after Pancreaticoduodenectomy
A Multicenter, Randomized, Placebo-controlled Phase II trial

Acronym

The JAPAN-PD Study

Scientific Title

Effect of Daikenchuto on Postoperative Bowel Motility and on Prevention of Paralytic Ileus after Pancreaticoduodenectomy
A Multicenter, Randomized, Placebo-controlled Phase II trial

Scientific Title:Acronym

The JAPAN-PD Study

Region

Japan

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

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroki Yamaue

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

Kimiidera, Wakayama 641-8510, Japan

TEL

073-441-0612

Email

yamaue-h@wakayama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Ken-ichi Okada

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

Kimiidera, Wakayama 641-8510, Japan

TEL

073-441-0613

Homepage URL

Email

okada@wakayama-med.ac.jp

Institute

Wakayama Medical University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2012

Year

08

Month

22

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

05

Month

19

Day

Date of IRB

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

Other related information

Registered date

2012

Year

05

Month

17

Day

Last modified on

2016

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009376