Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Panc… (NCT01607307) | Clinical Trial Compass
UnknownPhase 2
Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy
Japan220 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative paralytic ileus (including the duration of paralysis)
Timeframe: 72 hours
2
The duration until the first flatus after surgery.