Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma
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- 1 February 2017
- journal article
- research article
- Published by Wolters Kluwer Health in Annals of Surgery
- Vol. 265 (2), 277-283
- https://doi.org/10.1097/sla.0000000000001814
Abstract
OBJECTIVE To clarify the role of splenectomy in total gastrectomy for proximal gastric cancer. BACKGROUNDS Splenectomy in total gastrectomy is associated with increased operative morbidity and mortality, but its survival benefit is unclear. Previous randomized controlled trials were underpowered and inconclusive. METHODS We conducted a multiinstitutional randomized controlled trial. Proximal gastric adenocarcinoma of T2-4/N0-2/M0 not invading the greater curvature was eligible. During the operation, surgeons confirmed that R0 resection was possible with negative lavage cytology, and patients were randomly assigned to either splenectomy or spleen preservation. The primary endpoint was overall survival (OS) and the secondary endpoints were relapse-free survival, operative morbidity, operation time, and blood loss. The trial was designed to confirm noninferiority of spleen preservation to splenectomy in OS with a noninferiority margin of the hazard ratio as 1.21 and 1-sided alpha of 5%. RESULTS Between June 2002 and March 2009, 505 patients (254 splenectomy, 251 spleen preservation) were enrolled from 36 institutions. Splenectomy was associated with higher morbidity and larger blood loss, but the operation time was similar. The 5-year survivals were 75.1% and 76.4% in the splenectomy and spleen preservation groups, respectively. The hazard ratio was 0.88 (90.7%, confidence interval 0.67-1.16) (<1.21); thus, the noninferiority of spleen preservation was confirmed (P = 0.025). CONCLUSIONS In total gastrectomy for proximal gastric cancer that does not invade the greater curvature, splenectomy should be avoided as it increases operative morbidity without improving survival.Keywords
This publication has 23 references indexed in Scilit:
- Prognostic significance of splenectomy for patients with gastric adenocarcinoma undergoing total gastrectomy: A retrospective cohort studyInternational Journal of Surgery, 2014
- Gastric cancer: ESMO–ESSO–ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-upAnnals Of Oncology, 2013
- Effectiveness and safety of splenectomy for gastriccarcinoma: A meta-analysisWorld Journal of Gastroenterology, 2009
- Randomized clinical trial of splenectomy versus splenic preservation in patients with proximal gastric cancerBritish Journal of Surgery, 2006
- Gastric Cancer Surgery: Morbidity and Mortality Results From a Prospective Randomized Controlled Trial Comparing D2 and Extended Para-Aortic Lymphadenectomy—Japan Clinical Oncology Group Study 9501Journal of Clinical Oncology, 2004
- A prospective randomized study comparing D2 total gastrectomy versus D2 total gastrectomy plus splenectomy in 187 patients with gastric carcinomaSurgery, 2002
- Role of Splenectomy in Gastric Cancer Surgery: Adverse Effect of Elective Splenectomy on Longterm SurvivalJournal of the American College of Surgeons, 1997
- Postoperative morbidity and mortality after D1 and D2 resections for gastric cancer: preliminary results of the MRC randomised controlled surgical trialThe Lancet, 1996
- Preservation of the spleen improves survival after radical surgery for gastric cancer.Gut, 1995
- Randomised comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patientsThe Lancet, 1995