Investigation of TJ-116 bukuryoingohangekobokuto for postoperative water brash in esophageal cancer.

Phase 4

Recruiting

• Conditions: Esophageal cancer; esophageal cancer; D004938

• Registration Number: JPRN-jRCTs021190001
• Lead Sponsor: Ishii Tadashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Patients waiting for chest upper to lower
esophageal cancer radical resection
2. Pre treatment cStage:II, III, IVA (except for T4b, N3) TNM classification:T=1-4a, N=0-2, M=0(TNM-UICC 8 th edition)
3. Performance Status:0-2
4. Hospital Anxiety and Depression Scale (HADS): 8 <=
5. 20 years old and over
6. Medical examination classification:outpatient and inpatient
7. Patients who obtain document consent from the principal

Exclusion Criteria

1. Patients who have past history of abdominal surgery
2 Patients who have past history of ileus
3 Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease
4. Eemergent surgery
5. Patients who took prohibited concomitant drugs 4 weeks before treatment
6. Patients who have past history of radiotherapy and radiation chemotherapy for esophageal cancer
7. Patients who have past history of allergy for other Kampo formulation(s) or lactose intolerance
8. Patients who have serious concomitant diseases
9. A woman who is pregnant, has a possibility of pregnancy, is within 28 days after birth, is breastfeeding
10. Dementia patients
11. Others, including patients who are unfit for the study as determined by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of feeling, anxiety, water brash

Secondary Outcome Measures

Name	Time	Method
1. Incidence frequency of aspiration pneumonia <br>2. Postoperative hospital stay <br>3. Abdominal gas volume <br>4. Inflammatory marker (IL-6,TNFa,G-CSF,WBC) <br>5. Chest CT <br>6. Nutritional status (Body weight, BMI, SMI, Grip strength,In Body Analysis, CONUT, nutrition-related markers) <br>7. Clinical examination