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Randomized Controlled Trial
. 2024 Aug 1;159(8):900-908.
doi: 10.1001/jamasurg.2024.1210.

Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial

Bang Wool Eom  1 , Hong Man Yoon  1 , Young-Woo Kim  1 , Jae-Seok Min  2   3 , Ji Yeong An  4   5 , Hoon Hur  6 , Young Joon Lee  7 , Gyu Seok Cho  8 , Young Kyu Park  9 , Mi Ran Jung  9 , Ji Ho Park  7 , Woo Jin Hyung  4 , Sang Ho Jeong  7 , Myeong-Cherl Kook  1 , Mira Han  10   11 , Byung-Ho Nam  12   13 , Keun Won Ryu  1 ; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial

Bang Wool Eom et al. JAMA Surg. .

Erratum in

  • Error in Author Affiliation.
    [No authors listed] [No authors listed] JAMA Surg. 2024 Aug 1;159(8):960. doi: 10.1001/jamasurg.2024.2710. JAMA Surg. 2024. PMID: 38985490 Free PMC article. No abstract available.

Abstract

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.

Trial registration: ClinicalTrials.gov Identifier: NCT01804998.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Yoon reported a patent for alginate-based injectable hydrogel system licensed to Dr Choi. Dr Hyung reported personal fees from Hutom outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
CT indicates computed tomography; LSG, laparoscopic standard gastrectomy; LSNNS, laparoscopic sentinel node navigation surgery; mITT, modified intent to treat; QoL, quality of life; RCT, randomized clinical trial.
Figure 2.
Figure 2.. Mean Changes in Physical Functioning and Appetite Loss
Physical functioning and appetite loss were measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) scores. Dysphagia and Eating Restriction were measured by EORTC QLQ Stomach Module scores. Higher scores indicate better function or worse symptoms. Error bars represent SEs. Preop indicates preoperative.
Figure 3.
Figure 3.. Mean Changes in Nutritional Indicators
Error bars represent standard errors.
See this image and copyright information in PMC

Comment on

References

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