TY - JOUR
T1 - Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer A Secondary Analysis of the SENORITA Randomized Clinical Trial
AU - Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
AU - Eom, Bang Wool
AU - Yoon, Hong Man
AU - Kim, Young Woo
AU - Min, Jae Seok
AU - An, Ji Yeong
AU - Hur, Hoon
AU - Lee, Young Joon
AU - Cho, Gyu Seok
AU - Park, Young Kyu
AU - Jung, Mi Ran
AU - Park, Ji Ho
AU - Hyung, Woo Jin
AU - Jeong, Sang Ho
AU - Kook, Myeong Cherl
AU - Han, Mira
AU - Nam, Byung Ho
AU - Ryu, Keun Won
N1 - Publisher Copyright:
© 2024 American Medical Association. All rights reserved.
PY - 2024/8/14
Y1 - 2024/8/14
N2 - IMPORTANCE The Sentinel Node Oriented Tailored Approach (SENORITA) randomized clinical trial evaluated quality of life (QoL) and nutritional outcomes between the laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG). However, there has been no report on the QoL and nutritional outcomes of patients who underwent stomach-preserving surgery among the LSNNS group. OBJECTIVE To compare long-term QoL and nutritional outcomes between patients who underwent stomach-preserving surgery and those who underwent standard gastrectomy and to identify factors associated with poor QoL outcomes in patients who underwent stomach-preserving surgery. DESIGN, SETTING, AND PARTICIPANTS This study is a secondary analysis of the SENORITA trial, a randomized clinical trial comparing LSNNS with LSG. Patients from 7 tertiary or general hospitals across the Republic of Korea were enrolled from March 2013 to December 2016, with follow-up through 5 years. Data were analyzed between August and September 2022. Among trial participants, patients who underwent actual laparoscopic standard gastrectomy in the LSG group and those who underwent stomach-preserving surgery in the LSNNS group were included. Patients who did not complete the baseline or any follow-up questionnaire were excluded. INTERVENTION Stomach-preserving surgery vs standard gastrectomy. MAIN OUTCOMES AND MEASURES Overall European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) scores, body mass index, hemoglobin, protein, and albumin levels. RESULTS A total of 194 and 257 patients who underwent stomach-preserving surgery and standard gastrectomy, respectively, were included in this study (mean [SD] age, 55.6 [10.6] years; 249 [55.2%] male). The stomach-preserving group had better QoL scores at 3 months postoperatively in terms of physical function (87.2 vs 83.9), dyspnea (5.9 vs 11.2), appetite loss (13.1 vs 19.4), dysphagia (8.0 vs 12.7), eating restriction (10.9 vs 18.2), anxiety (29.0 vs 35.2), taste change (7.4 vs 13.0), and body image (19.5 vs 27.2). At 1 year postoperatively, the stomach-preserving group had significantly higher body mass index (23.9 vs 22.1, calculated as weight in kilograms divided by height in meters squared) and hemoglobin (14.3 vs 13.3 g/dL), albumin (4.3 vs 4.25 g/dL), and protein (7.3 vs 7.1 g/dL) levels compared to the standard group. Multivariable analyses showed that tumor location (greater curvature, lower third) was favorably associated with global health status (β, 10.5; 95% CI, 3.2 to 17.8), reflux (β, −8.4; 95% CI, −14.7 to −2.1), and eating restriction (β, −5.7; 95% CI, −10.3 to −1.0) at 3 months postoperatively in the stomach-preserving group. Segmental resection was associated with risk of diarrhea (β, 40.6; 95% CI, 3.1 to 78.1) and eating restriction (β, 15.1; 95% CI, 1.1 to 29.1) at 3 years postoperatively. CONCLUSIONS AND RELEVANCE Stomach-preserving surgery after sentinel node evaluation was associated with better long-term QoL and nutritional outcomes than standard gastrectomy. These findings may help facilitate decision-making regarding treatment for patients with early-stage gastric cancer.
AB - IMPORTANCE The Sentinel Node Oriented Tailored Approach (SENORITA) randomized clinical trial evaluated quality of life (QoL) and nutritional outcomes between the laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG). However, there has been no report on the QoL and nutritional outcomes of patients who underwent stomach-preserving surgery among the LSNNS group. OBJECTIVE To compare long-term QoL and nutritional outcomes between patients who underwent stomach-preserving surgery and those who underwent standard gastrectomy and to identify factors associated with poor QoL outcomes in patients who underwent stomach-preserving surgery. DESIGN, SETTING, AND PARTICIPANTS This study is a secondary analysis of the SENORITA trial, a randomized clinical trial comparing LSNNS with LSG. Patients from 7 tertiary or general hospitals across the Republic of Korea were enrolled from March 2013 to December 2016, with follow-up through 5 years. Data were analyzed between August and September 2022. Among trial participants, patients who underwent actual laparoscopic standard gastrectomy in the LSG group and those who underwent stomach-preserving surgery in the LSNNS group were included. Patients who did not complete the baseline or any follow-up questionnaire were excluded. INTERVENTION Stomach-preserving surgery vs standard gastrectomy. MAIN OUTCOMES AND MEASURES Overall European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) scores, body mass index, hemoglobin, protein, and albumin levels. RESULTS A total of 194 and 257 patients who underwent stomach-preserving surgery and standard gastrectomy, respectively, were included in this study (mean [SD] age, 55.6 [10.6] years; 249 [55.2%] male). The stomach-preserving group had better QoL scores at 3 months postoperatively in terms of physical function (87.2 vs 83.9), dyspnea (5.9 vs 11.2), appetite loss (13.1 vs 19.4), dysphagia (8.0 vs 12.7), eating restriction (10.9 vs 18.2), anxiety (29.0 vs 35.2), taste change (7.4 vs 13.0), and body image (19.5 vs 27.2). At 1 year postoperatively, the stomach-preserving group had significantly higher body mass index (23.9 vs 22.1, calculated as weight in kilograms divided by height in meters squared) and hemoglobin (14.3 vs 13.3 g/dL), albumin (4.3 vs 4.25 g/dL), and protein (7.3 vs 7.1 g/dL) levels compared to the standard group. Multivariable analyses showed that tumor location (greater curvature, lower third) was favorably associated with global health status (β, 10.5; 95% CI, 3.2 to 17.8), reflux (β, −8.4; 95% CI, −14.7 to −2.1), and eating restriction (β, −5.7; 95% CI, −10.3 to −1.0) at 3 months postoperatively in the stomach-preserving group. Segmental resection was associated with risk of diarrhea (β, 40.6; 95% CI, 3.1 to 78.1) and eating restriction (β, 15.1; 95% CI, 1.1 to 29.1) at 3 years postoperatively. CONCLUSIONS AND RELEVANCE Stomach-preserving surgery after sentinel node evaluation was associated with better long-term QoL and nutritional outcomes than standard gastrectomy. These findings may help facilitate decision-making regarding treatment for patients with early-stage gastric cancer.
UR - http://www.scopus.com/inward/record.url?scp=85195082935&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85195082935&partnerID=8YFLogxK
U2 - 10.1001/jamasurg.2024.1210
DO - 10.1001/jamasurg.2024.1210
M3 - Article
C2 - 38809537
AN - SCOPUS:85195082935
SN - 2168-6254
VL - 159
SP - 900
EP - 908
JO - JAMA Surgery
JF - JAMA Surgery
IS - 8
ER -