Gastrectomy
Conditions
Keywords
Distal gastrectomy, Reconstruction, Reflux, subtotal gastrectomy
Brief summary
The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer
Detailed description
Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure. Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.
Interventions
PROCEDUREBillroth-I
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.
PROCEDURERoux en Y
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with adenocarcinoma at the endoscopic biopsy * Patients who are possible to be performed curative resection in imaging study * Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach * Patients with informed consent * Patients with three or less American Society Anesthesiology Score 3
Exclusion criteria
* Patients who are or become pregnant * Patients with uncontrolled disease * Patient s with synchronous other malignancy * Patients participated in other clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflux of bile content | 6 months after surgery | We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 2 month after surgery | We investigate the occurrence of complication during recovery after surgery. |
| Anastomotic time | Day 1 | We estimate anastomosis time |
| Quality of Life | 6 months after surgery | We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC). |
| Mortality | 2 month after operation | We investigate the occurrence of operation-related death during recovery after surgery. |
| Operation time | Day 1 | We estimate total operation time. |
| Nutritional state | 6 month after surgery | We estimate Albumin, transferrin, lymphocyte, body weight |
Countries
South Korea
Contacts
Primary ContactHoon Hur, M.D.
Backup ContactSang-Uk Han, M.D.
Outcome results
None listed