Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy (JAPAN-PD)
Recruitment status was: Active, not recruiting
|Paralytic Ileus||Drug: Oral/enteral TJ-100 solution Drug: Oral/enteral placebo solution||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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|
- 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.
- QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) [ Time Frame: 7 days ]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 ]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 ]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 ]The incidence of postoperative complication based on Dindo's classification.
- The length of postoperative hospital day. [ Time Frame: 30 days ]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 ]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 ]The follow-up investigation of the long term incidence of postoperative ileus is scheduled in two years after surgery.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2016|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607307
|Nagoya, Aichi, Japan|
|Suita, Osaka, Japan|
|Shizuoka Cancer Center Hospital|
|Wakayama Medical University|
|Wakayama, Japan, 641-8510|
|Principal Investigator:||Hiroki Yamaue, M.D., Ph.D.||Second Department of Surgery, Wakayama Medical University|