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

Phase 3
20 Years
75 Years
Not Enrolling
Stomach Cancer, Gastrectomy

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Trial Information

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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Bile reflux by Dual scintigraphy

Outcome Time Frame:

six month and one year after operation

Safety Issue:


Principal Investigator

Wook Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Holy Family Hospital, The Catholic University of Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

Related Keywords:

  • Stomach Cancer
  • Gastrectomy
  • Stomach cancer
  • Gastrectomy
  • Postgastrectomy syndrome
  • Bile Reflux
  • Stomach Neoplasms
  • Gastroparesis