Stomach Cancer Clinical Trial
Official title:
Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy
NCT number | NCT00622804 |
Other study ID # | HCHC06OT049 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | February 14, 2008 |
Last updated | July 31, 2009 |
Start date | July 2007 |
Verified date | July 2009 |
Source | The Catholic University of Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 90 |
Est. completion date | |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Surgery, Holy Family Hospital, The Catholic University of Korea | Bucheon | |
Korea, Republic of | Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea | In Cheon | |
Korea, Republic of | Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea | Seoul | |
Korea, Republic of | Department of Surgery, St Mary's Hospital, The Catholic University of Korea | Seoul | |
Korea, Republic of | Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea | Suwon |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
Ogoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. Epub 2004 Sep 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bile reflux by Dual scintigraphy | six month and one year after operation | No | |
Secondary | Gastric emptying time by Dual scintigraphy | six month and one year after operation | No | |
Secondary | Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings | six month and one year after operation | No | |
Secondary | Quality of life by EORTC QLQ30, STO22 | one year after operation | No | |
Secondary | Morbidity and Mortality | In hosipital | Yes |
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