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Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9932836/ https://www.ncbi.nlm.nih.gov/pubmed/36790808 http://dx.doi.org/10.1001/jamanetworkopen.2022.56004 |
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author | Park, Do Joong Han, Sang-Uk Hyung, Woo Jin Hwang, Sun-Hwi Hur, Hoon Yang, Han-Kwang Lee, Hyuk-Joon Kim, Hyoung-Il Kong, Seong-Ho Kim, Young Woo Lee, Han Hong Kim, Beom Su Park, Young-Kyu Lee, Young-Joon Ahn, Sang-Hoon Lee, Inseob Suh, Yun-Suhk Park, Ji-Ho Ahn, Soyeon Park, Young Suk Kim, Hyung-Ho |
author_facet | Park, Do Joong Han, Sang-Uk Hyung, Woo Jin Hwang, Sun-Hwi Hur, Hoon Yang, Han-Kwang Lee, Hyuk-Joon Kim, Hyoung-Il Kong, Seong-Ho Kim, Young Woo Lee, Han Hong Kim, Beom Su Park, Young-Kyu Lee, Young-Joon Ahn, Sang-Hoon Lee, Inseob Suh, Yun-Suhk Park, Ji-Ho Ahn, Soyeon Park, Young Suk Kim, Hyung-Ho |
author_sort | Park, Do Joong |
collection | PubMed |
description | 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 B(12) supplementation 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 B(12) supplementation 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, −4.0% to 1.4%; P = .35). The mean (SD) cumulative amount of vitamin B(12) supplementation was 0.4 (1.3) mg in the LPG-DTR group and 2.5 (3.0) mg in the LTG group, for an estimated difference of 2.1 mg (95% CI, 1.3-2.9 mg; P < .001). The late complication rates in the LPG-DTR and LTG groups were 17.6% and 10.1%, respectively (P = .31). The incidence of reflux esophagitis was not different between the LPG-DTR and LTG groups (2.9% vs 2.9%; P = .99). Compared with the LTG group, the LPG-DTR group had better physical functioning scores (85.2 [15.6] vs 79.9 [19.3]; P = .03) and social functioning scores (89.5 [17.9] vs 82.4 [19.4]; P = .03) on the EORTC QLQ-C30. Two-year overall survival (98.5% vs 100%; P = .33) and disease-free survival (98.5% vs 97.1%; P = .54) did not significantly differ between the LPG-DTR vs LTG groups. CONCLUSIONS AND RELEVANCE: In this study, patients with upper-third early GC who received LPG-DTR required less vitamin B(12) supplementation than those who received LTG, with no increase in complication rates and no difference in overall and disease-free survival rates. There was no difference in change in hemoglobin level between groups. In addition, the LPG-DTR group had better physical and social functioning than the LTG group. These findings suggest that LPG-DTR may be as safe as LTG and may be a function-preserving procedure for the treatment of patients with upper-third early GC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02892643 |
format | Online Article Text |
id | pubmed-9932836 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | American Medical Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-99328362023-02-17 Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial Park, Do Joong Han, Sang-Uk Hyung, Woo Jin Hwang, Sun-Hwi Hur, Hoon Yang, Han-Kwang Lee, Hyuk-Joon Kim, Hyoung-Il Kong, Seong-Ho Kim, Young Woo Lee, Han Hong Kim, Beom Su Park, Young-Kyu Lee, Young-Joon Ahn, Sang-Hoon Lee, Inseob Suh, Yun-Suhk Park, Ji-Ho Ahn, Soyeon Park, Young Suk Kim, Hyung-Ho JAMA Netw Open Original Investigation 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 B(12) supplementation 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 B(12) supplementation 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, −4.0% to 1.4%; P = .35). The mean (SD) cumulative amount of vitamin B(12) supplementation was 0.4 (1.3) mg in the LPG-DTR group and 2.5 (3.0) mg in the LTG group, for an estimated difference of 2.1 mg (95% CI, 1.3-2.9 mg; P < .001). The late complication rates in the LPG-DTR and LTG groups were 17.6% and 10.1%, respectively (P = .31). The incidence of reflux esophagitis was not different between the LPG-DTR and LTG groups (2.9% vs 2.9%; P = .99). Compared with the LTG group, the LPG-DTR group had better physical functioning scores (85.2 [15.6] vs 79.9 [19.3]; P = .03) and social functioning scores (89.5 [17.9] vs 82.4 [19.4]; P = .03) on the EORTC QLQ-C30. Two-year overall survival (98.5% vs 100%; P = .33) and disease-free survival (98.5% vs 97.1%; P = .54) did not significantly differ between the LPG-DTR vs LTG groups. CONCLUSIONS AND RELEVANCE: In this study, patients with upper-third early GC who received LPG-DTR required less vitamin B(12) supplementation than those who received LTG, with no increase in complication rates and no difference in overall and disease-free survival rates. There was no difference in change in hemoglobin level between groups. In addition, the LPG-DTR group had better physical and social functioning than the LTG group. These findings suggest that LPG-DTR may be as safe as LTG and may be a function-preserving procedure for the treatment of patients with upper-third early GC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02892643 American Medical Association 2023-02-15 /pmc/articles/PMC9932836/ /pubmed/36790808 http://dx.doi.org/10.1001/jamanetworkopen.2022.56004 Text en Copyright 2023 Park DJ et al. JAMA Network Open. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the CC-BY-NC-ND License. |
spellingShingle | Original Investigation Park, Do Joong Han, Sang-Uk Hyung, Woo Jin Hwang, Sun-Hwi Hur, Hoon Yang, Han-Kwang Lee, Hyuk-Joon Kim, Hyoung-Il Kong, Seong-Ho Kim, Young Woo Lee, Han Hong Kim, Beom Su Park, Young-Kyu Lee, Young-Joon Ahn, Sang-Hoon Lee, Inseob Suh, Yun-Suhk Park, Ji-Ho Ahn, Soyeon Park, Young Suk Kim, Hyung-Ho Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial |
title | Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial |
title_full | Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial |
title_fullStr | Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial |
title_full_unstemmed | Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial |
title_short | Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B(12) Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial |
title_sort | effect of laparoscopic proximal gastrectomy with double-tract reconstruction vs total gastrectomy on hemoglobin level and vitamin b(12) supplementation in upper-third early gastric cancer: a randomized clinical trial |
topic | Original Investigation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9932836/ https://www.ncbi.nlm.nih.gov/pubmed/36790808 http://dx.doi.org/10.1001/jamanetworkopen.2022.56004 |
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