Spots Global Cancer Trial Database for Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy
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Trial Identification
Brief Title: Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy
Official Title: Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy
Study ID: NCT00622804
Study Description
Brief Summary: 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).
Detailed Description: Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, 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). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on. From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, , Korea, Republic of
Contact Details
Name: Wook Kim, MD, PhD
Affiliation: Department of Surgery, Holy Family Hospital, The Catholic University of Korea
Role: PRINCIPAL_INVESTIGATOR
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