Patients with pancreatic head tumors undergoing pancreaticoduodenectomy
Conditions
Interventions
Oral administration of test drug (Daikenchuto) 5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before or after meals between preoperative day3 to postoperative day7
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)PS(ECOG Performance Status Scale):0-2 2)Patients who are diagnosed as abdominal pain or distention CTCAE≥1 by the attending physician preoperatively (when they provide written informed consent) 3)Patients who is able to have oral intake of the test drugs 4)Age: 20 years or older 5)Gender: no specification 6)2weeks or more blank after therapy is needed in case of receiving chemoradiotherapy 7)Adequate organ function and operable patient 8)Patients who can provide written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with ischemic heart disease requiring treatment 2)Patients with liver cirrhosis or active hepatitis 3)Patients with interstitial pneumonitis or emphysema 4)Patients with chronic renal failure requiring dialysis 5)Patients with active duplicative malignant disease affecting adverse event 6)Patients who are scheduled to undergo pancreaticoduodenectomy together with other organs 7)Patients with history of intestinal resection 8)Patients who are administered another gastrointestinal prokinetic agents 9)Patients who need another Kampo medicines for medical treatment 10)Others, patients who are unfit for the study as determined by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Number of postoperative day to comfirm normal bowel sound. 2)Number of postoperative day to comfirm first flatus. 3)Abdominal circumference 4)Bowel gas image | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)QOL assessment by the GSRS Score (Japanese Version) 2)Postoperative cytokine and diamine oxidase(DAO) level in serum and ascites 3)Incidence of postoperative intestinal obstruction 4)Incidence of postoperative complications 5)Postoperative length of stay | — |
Countries
Japan
Outcome results
None listed