Clinical Trial: Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy

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 Summary:

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.


Sponsor: The Catholic University of Korea

Current Primary Outcome: Bile reflux by Dual scintigraphy [ Time Frame: six month and one year after operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gastric emptying time by Dual scintigraphy [ Time Frame: six month and one year after operation ]
  • Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings [ Time Frame: six month and one year after operation ]
  • Quality of life by EORTC QLQ30, STO22 [ Time Frame: one year after operation ]
  • Morbidity and Mortality [ Time Frame: In hosipital ]


Original Secondary Outcome: Same as current

Information By: The Catholic University of Korea

Dates:
Date Received: February 14, 2008
Date Started: July 2007
Date Completion:
Last Updated: July 31, 2009
Last Verified: July 2009