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

Phase 3

Withdrawn

• Conditions: Gastrectomy; Stomach Cancer
• Interventions: Procedure: Billroth-II (B-II); Procedure: Roux en Y gastrojejunostomy (RY-GJ); Procedure: uncut Roux en Y gastrojejunostomy

• Registration Number: NCT00622804
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Last Update Submitted: 2009-07-31
• Last Update Posted: 2009-08-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Billroth-II (B-II)	Billroth-II (B-II)reconstruction
2	Roux en Y gastrojejunostomy (RY-GJ)	Roux en Y gastrojejunostomy (RY-GJ)
3	uncut Roux en Y gastrojejunostomy	uncut Roux en Y gastrojejunostomy (uncut RY-GJ)

Primary Outcome Measures

Name	Time	Method
Bile reflux by Dual scintigraphy	six month and one year after operation

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea; 🇰🇷 In Cheon, Korea, Republic of

Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea; 🇰🇷 Suwon, Korea, Republic of

Department of Surgery, Holy Family Hospital, The Catholic University of Korea; 🇰🇷 Bucheon, Korea, Republic of

Department of Surgery, St Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of