Effect of Laparoscopic Proximal Gastrectomy with Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B12Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial
2023
Online
academicJournal
Zugriff:
Importance: Patients undergoing proximal gastrectomy (PG) with double-tract reconstruction (DTR) have been reported to have an incidence of reflux esophagitis that is as low as that observed after total gastrectomy (TG). It is unclear whether PG has an advantage over TG for the treatment of patients with upper early gastric cancer (GC). Objective: To evaluate the effect of laparoscopic PG with DTR (LPG-DTR) vs laparoscopic TG (LTG) on levels of hemoglobin and vitamin B12supplementation required among patients with clinically early GC in the upper third of the stomach (upper-third early GC). Design, Setting, and Participants: This multicenter open-label superiority randomized clinical trial was conducted at 10 institutions in Korea. A total of 138 patients with upper-third cT1N0M0 GC were enrolled between October 27, 2016, and September 9, 2018. Follow-up ended on December 3, 2020. Interventions: Patients were randomized to undergo either LPG-DTR or LTG. Main Outcomes and Measures: The primary co-end points were change in hemoglobin level and cumulative amount of vitamin B12supplementation at 2 years after LPG-DTR or LTG. The secondary end points included morbidity, postoperative reflux esophagitis, 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. Results: Among 138 patients (mean [SD] age, 60.0 [10.9] years; 87 men [63.0%]; all of Asian race and Korean ethnicity), 68 (mean [SD] age, 56.7 [10.4] years; 39 men [57.4%]) were randomized to receive LPG-DTR and 69 (mean [SD] age, 61.3 [11.3] years; 48 men [69.6%]) were randomized to receive LTG. The mean (SD) changes in hemoglobin levels from baseline to month 24 were -5.6% (7.4%) in the LPG-DTR group and -6.9% (8.3%) in the LTG group, for an estimated difference of -1.3% (95% CI, ...
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Effect of Laparoscopic Proximal Gastrectomy with Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B12Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial
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Autor/in / Beteiligte Person: | Park, DJ ; Han, SU ; Hyung, WJ ; Hwang, SH ; Hur, H ; Yang, HK ; Lee, HJ ; Kim, HI ; Kong, SH ; Kim, YW ; Lee, HH ; Kim, BS ; Park, YK ; Lee, YJ ; Ahn, SH ; Lee, I ; Suh, YS ; Park, JH ; Ahn, S ; Park, YS ; Kim, HH ; 102264 ; 107797 |
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Veröffentlichung: | 2023 |
Medientyp: | academicJournal |
ISSN: | 2574-3805 (print) |
DOI: | 10.1001/jamanetworkopen.2022.56004 |
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