Clinical trial NCT00622804: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Stomach Cancer
Gastrectomy
Keywords: Stomach cancer
Gastrectomy
Postgastrectomy syndrome
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: Bile reflux by Dual scintigraphy
timeFrame: six month and one year after operation
Secondary outcomes:
measure: Gastric emptying time by Dual scintigraphy
timeFrame: six month and one year after operation
measure: Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings
timeFrame: six month and one year after operation
measure: Quality of life by EORTC QLQ30, STO22
timeFrame: one year after operation
measure: Morbidity and Mortality
timeFrame: In hosipital
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Department of Surgery, Holy Family Hospital, The Catholic University of Korea
city: In Cheon
country: Korea, Republic of
facility: Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, St Mary's Hospital, The Catholic University of Korea
city: Suwon
country: Korea, Republic of
facility: Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea
Study officials:
affiliation: Department of Surgery, Holy Family Hospital, The Catholic University of Korea
name: Wook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ogoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. doi: 10.1159/000087046. Epub 2004 Sep 6.