Effect of Daikenchuto on Postoperative Bowel Motility and on Prevention of Paralytic Ileus after Pancreaticoduodenectomy A Multicenter, Randomized, Placebo-controlled Phase II trial

Phase 2

• Conditions: The 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 pancreas who are expected to undergo pancreaticoduodenectomy

• Registration Number: JPRN-UMIN000007975
• Lead Sponsor: Wakayama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-22
• Study Completion: 2016-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

i)Clinically problematic cardiac disease. ii)Liver cirrhosis or active hepatitis. iii)Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.). iv)Chronic renal failure requiring hemodialysis. v)Other malignant disease that can influence the adverse effect. vi)Patients with tumors requiring resection of colon. vii)Patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history. viii)Patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants. ix)Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration. x)Pregnant or lactating women. xi)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are the incidence of postoperative paralytic ileus and the duration until the first flatus after surgery.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale about abdominal pain and abdominal distention, the change ratio of abdominal circumference on postoperative day 3 and operative day just after surgery, the incidence of postoperative complication, the length of postoperative hospital day, the incidence of surgical site infection and the incidence of postoperative small bowel obstruction within 2 years after surgery.