Gastrectomy, Stomach Cancer
Conditions
Keywords
Stomach cancer, Gastrectomy, Postgastrectomy syndrome
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.
Interventions
PROCEDUREBillroth-II (B-II)
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.
PROCEDURERoux en Y gastrojejunostomy (RY-GJ)
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.
PROCEDUREuncut Roux en Y gastrojejunostomy
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.
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bile reflux by Dual scintigraphy | six month and one year after operation |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed