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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stomach Cancer, Gastrectomy

Intervention / Treatment
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* Procedure: Billroth-II (B-II)
* Procedure: Roux en Y gastrojejunostomy (RY-GJ)
* Procedure: uncut Roux en Y gastrojejunostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria: have cancer located in middle or distal portions preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally) have The American Society of Anaesthesiologists (ASA) score of three and less Exclusion Criteria: Patients following criteria: have simultaneously other cancer underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time have systemic inflammatory disease have upper gastrointestinal surgery have the gastric cancer with obstruction get pregnancy are treating diabetics with Insulin are participating or participated within 1 month in other clinical trials have BMI less than 25 are expected to perform laparoscopy assisted gastrectomy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Billroth-II (B-II)reconstruction | Procedure: Billroth-II (B-II)<br>* After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.<br>* Other names: B-II;|
| Other: 2<br>Roux en Y gastrojejunostomy (RY-GJ) | Procedure: Roux en Y gastrojejunostomy (RY-GJ)<br>* After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.<br>* Other names: RY-GJ;|
| Other: 3<br>uncut Roux en Y gastrojejunostomy (uncut RY-GJ) | Procedure: uncut Roux en Y gastrojejunostomy<br>* After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.<br>* Other names: uncut RY-GJ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bile reflux by Dual scintigraphy |  | six month and one year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time by Dual scintigraphy |  | six month and one year after operation | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach cancer, Gastrectomy, Postgastrectomy syndrome