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The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction | Experimental |
| |
| laparoscopic proximal gastrectomy with double-tract reconstruction | Active Comparator |
| |
| laparoscopic proximal gastrectomy with tube-like stomach reconstruction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy | Procedure | laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reflux esophagitis | At 1 year after LPG |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anastomotic leakage | At 1 year after LPG | |
| Incidence of anastomotic stenosis | At 1 year after LPG | |
| Operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiajie Zhou | Yangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39580964 | Derived | Tian Z, Cheng Y, Wang Y, Ren J, Wang S, Wang D. A 3-Arm case-matched analysis of anti-reflux reconstruction methods after laparoscopic proximal gastrectomy - Single tract jejunal interposition vs double tract reconstruction vs tube-like stomach reconstruction. Eur J Surg Oncol. 2025 Feb;51(2):109482. doi: 10.1016/j.ejso.2024.109482. Epub 2024 Nov 19. |
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| Intraoperative |
| Intra-operative blood loss | Intraoperative |
| Overall survival, and disease-free survival | At 1 and 3 years after LPG |