Paralytic IleusPhase 2JAPAN-PDNCT01607307
Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy
A Phase 2 study testing Oral/enteral TJ-100 solution in people with Paralytic Ileus, run by Wakayama Medical University at 5 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Paralytic Ileus
- What is being tested?
- Oral/enteral TJ-100 solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 5 sitesJapan
- Study dates
- Aug 2012to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Hiroshima University
Hiroshima, Hiroshima
Nagoya University
Nagoya, Aichi-ken
Shizuoka Cancer Center Hospital
Shizuoka, Shizuoka
Osaka University
Suita, Osaka
Wakayama Medical University
Wakayama, Wakayama, 641-8510
About this study
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
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.
Read the 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).
- Conditions
- Paralytic Ileus
- Being tested
- Oral/enteral TJ-100 solution, Oral/enteral placebo solution
- Keywords
- daikenchuto, postoperative ileus, pancreaticoduodenectomy
- Medical subject headings
- Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral/enteral TJ-100 solutionDrug
Also called A
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.
Oral/enteral placebo solutionDrug
Also called B
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral/enteral TJ-100 solution | Active comparator | Oral/enteral TJ-100 solution Receives: Drug: Oral/enteral TJ-100 solution |
| Oral/enteral placebo solution | Placebo comparator | Oral/enteral placebo solution Receives: Drug: Oral/enteral placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative paralytic ileus (including the duration of paralysis)
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.
Measured: 72 hours
The duration until the first flatus after surgery.
The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.
Measured: 14 days
Secondary outcomes (7)
QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)
QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) on postoperative day 7.
Measured: 7 days
Abdominal pain and abdominal distention scores on the Visual Analogue Scale.
Abdominal pain and abdominal distention scores on the Visual Analogue Scale on postoperative day 3.
Measured: 3 days
The change ratio of abdominal circumference.
The change ratio of abdominal circumference on postoperative day 3 and operative day just after surgery
Measured: 3 days
The incidence of postoperative complication.
The incidence of postoperative complication based on Dindo's classification.
Measured: 14 days
The length of postoperative hospital day.
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.
Measured: 30 days
The incidence of surgical site infection.
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.
Measured: 30 days
The long term incidence of postoperative ileus after surgery.
The follow-up investigation of the long term incidence of postoperative ileus is scheduled in two years after surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paralytic IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Responsible party
- Principal investigator, Hiroki Yamaue, Wakayama Medical University
- Investigators
- Hiroki Yamaue, M.D., Ph.D., Principal investigator, Second Department of Surgery, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607307
- Sponsor's protocol ID
- JAPAN-PD
- Other IDs
- UMIN000007975
- Acronym
- JAPAN-PD
- Status last verified
- Aug 2012
- First submitted
- 16 May 2012
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30333892Okada 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.
PubMed 26747224
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01607307
- Acronym / sponsor ID
- JAPAN-PD / JAPAN-PD
- Conditions
- Paralytic Ileus
- Keywords
- daikenchuto, postoperative ileus, pancreaticoduodenectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral/enteral TJ-100 solution | Active comparator | Drug: Oral/enteral TJ-100 solutionOral/enteral TJ-100 solution |
| Oral/enteral placebo solution | Placebo comparator | Drug: Oral/enteral placebo solutionOral/enteral placebo solution |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral/enteral TJ-100 solutionAlso: AOral 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. | Drug | Oral/enteral TJ-100 solution |
| Oral/enteral placebo solutionAlso: BOral 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. | Drug | Oral/enteral placebo solution |
Primary outcome
Incidence of postoperative paralytic ileus (including the duration of paralysis)
Time frame: 72 hours
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
The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.
7 secondary outcomes
QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)
Time frame: 7 days
Abdominal pain and abdominal distention scores on the Visual Analogue Scale.
Time frame: 3 days
The change ratio of abdominal circumference.
Time frame: 3 days
The incidence of postoperative complication.
Time frame: 14 days
The length of postoperative hospital day.
Time frame: 30 days
The incidence of surgical site infection.
Time frame: 30 days
The long term incidence of postoperative ileus after surgery.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Derived from this study: PubMed 30333892Maeda 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.
- Derived from this study: PubMed 26747224Okada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroki Yamaue, M.D., Ph.D. principal investigator
Second Department of Surgery, Wakayama Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral/enteral TJ-100 solution in people with Paralytic Ileus, run by Wakayama Medical University at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative paralytic ileus (including the duration of paralysis) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607307, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.