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
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).
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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