Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy
Sponsored by The Catholic University of Korea
About this trial
Last updated 17 years ago
Study ID
HCHC06OT049
Status
Withdrawn
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
20 to 75 Years
All Sexes
Trial Timing
Started 19 years ago
What is this trial about?
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
What are the participation requirements?
Inclusion Criteria
* Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:
1. have cancer located in middle or distal portions
2. preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
3. have The American Society of Anaesthesiologists (ASA) score of three and less
Exclusion Criteria
* Patients following criteria:
1. have simultaneously other cancer
2. underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
3. have systemic inflammatory disease
4. have upper gastrointestinal surgery
5. have the gastric cancer with obstruction
6. get pregnancy
7. are treating diabetics with Insulin
8. are participating or participated within 1 month in other clinical trials
9. have BMI less than 25
10. are expected to perform laparoscopy assisted gastrectomy