Efficacy and safety of temporary pyloric dilatation by intraoperative PraBotulinum toxin A Injection for the prevention of delayed Gastric Emptying immediate after Pylorus Preserving Gastrectomy for gastric cancer

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0004077
• Lead Sponsor: Chung-Ang Univerisity Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

? Patient confirmed by gastric cancer due to histological examination
? Stomach cancer located at the mid-third of the stomach (The distal margin of stomach cancer at least 5 cm away far from the pylorus)
? Clinical stage was cT1N0M0 (EGD, CT, EUS)
? 20 year-old ~ 60 year-old
? Patients whose Eastern Cooperative Oncology Group performance status is 0 or 1
? ASA score (American society of anesthesiology) Class I to III patients
? Before participating in the examination, please listen to the purpose and contents of the examination thoroughly and participate in this study according to the free will. The patient who signed the written consent of the institutional ethics review committee

Exclusion Criteria

? the duodenal ulcer with pyloric anomalies
? there is another stomach lesion that can not be done with pylorus-preserving gastrectomy (synchronous gastric cancer, adenoma, etc.)
? Pylorus-preserving gastrectomy is not possible due to past past surgery
? Liver Cirrhosis
? The patient with chemotherapy or radiotherapy before surgery
? Patients who need combined resection due to other diseases (eg, gallstone disease)
? Patients who underwent surgery for other organ primary carcinomas within the last 5 years or who received chemotherapy or radiotherapy (excluding cured skin basal cell carcinoma and in situ cervical cancer)
? Vulnerable subjects (those who lack mental capacity , expectant mothers or those planning pregnancy)
? Patients who have participated in other clinical trials within the last 6 months or are currently participating
? Persons with a disease that may affect neuromuscular function such as myasthenia gravis, Eaton-Rambutton syndrome, amyotrophic axillary sclerosis, and motor neuropathy
? Those who have taken the following drugs within 4 weeks before screening
- muscle relaxant: tuvocaralin system, mono trolene sodium, baclofen, etc.
- Aminoglycoside antibiotics: gentamycin sulfate, neomycin sulfate, etc.
- Other antibiotics: Dyes specinomycin, polyamicin, tetracycline, lincomycin, etc.
- Anticholinergic agents: butyl scopolamine bromide, trihexyphenidyl hydrochloride, etc.
- benzodiazepines and similar agents: diazepam, etiazolam, etc.
- Benzamide medicines: thiaflide hydrochloride, sulpiride, etc.
? Any person who is allergic or sensitive to a clinical trial drug or its ingredients
? Pregnant women
? Other patients who were deemed unsuitable for participating in this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Half life of Gastric emptying study

Secondary Outcome Measures

Name	Time	Method
incidence of delayed gastric emptying;Body weight and Fat volume change on abdominal CT scan;Change of Hemoglobin, Protein, and Albumin;Postoperative QOL measurement (EORTC C30/STO22);Gross findings on gastroscopy by RGB criteria;Half life of Gastric emptying study