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

• 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.
  
  

• 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.
  
  

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).