Trial record 2 of 5 for:    "intestinal pseudo-obstruction syndrome" OR "Intestinal Pseudo-Obstruction"

Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy (JAPAN-PD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT01607307
First received: May 16, 2012
Last updated: December 17, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Paralytic Ileus
Drug: Oral/enteral TJ-100 solution
Drug: Oral/enteral placebo solution
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Incidence of postoperative paralytic ileus (including the duration of paralysis) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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.

  • The duration until the first flatus after surgery. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.


Secondary Outcome Measures:
  • QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) on postoperative day 7.

  • Abdominal pain and abdominal distention scores on the Visual Analogue Scale. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Abdominal pain and abdominal distention scores on the Visual Analogue Scale on postoperative day 3.

  • The change ratio of abdominal circumference. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    The change ratio of abdominal circumference on postoperative day 3 and operative day just after surgery

  • The incidence of postoperative complication. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The incidence of postoperative complication based on Dindo's classification.

  • The length of postoperative hospital day. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Patients were discharged only when they fulfilled the criteria as follows: a return to preoperative activities of daily living, no deep-site infections, normal laboratory data, no drains, and the possibility for oral nutrition above the basal metabolism.

  • The incidence of surgical site infection. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Intra-abdominal abscess was defined as intra-abdominal fluid collection with positive cultures identified by ultrasonography or computed tomography associated with persistent fever and elevations of white blood cell counts.

  • The long term incidence of postoperative ileus after surgery. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The follow-up investigation of the long term incidence of postoperative ileus is scheduled in two years after surgery.


Estimated Enrollment: 220
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral/enteral TJ-100 solution
Oral/enteral TJ-100 solution
Drug: 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.
Other Name: A
Placebo Comparator: Oral/enteral placebo solution
Oral/enteral placebo solution
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.
Other Name: B

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607307

Locations
Japan
Nagoya University
Nagoya, Aichi, Japan
Osaka University
Suita, Osaka, Japan
Hiroshima University
Hiroshima, Japan
Shizuoka Cancer Center Hospital
Shizuoka, Japan
Wakayama Medical University
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Epidemiological and Clinical Research Information Network
Investigators
Principal Investigator: Hiroki Yamaue, M.D., Ph.D. Second Department of Surgery, Wakayama Medical University
  More Information

No publications provided

Responsible Party: Hiroki Yamaue, Professor, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT01607307     History of Changes
Other Study ID Numbers: JAPAN-PD, UMIN000007975
Study First Received: May 16, 2012
Last Updated: December 17, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Wakayama Medical University:
daikenchuto
postoperative ileus
pancreaticoduodenectomy

Additional relevant MeSH terms:
Intestinal Pseudo-Obstruction
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014