Download This Paper
Preprints with The Lancet is a collaboration between The Lancet Group of journals and SSRN to facilitate the open sharing of preprints for early engagement, community comment, and collaboration. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early-stage research papers that have not been peer-reviewed. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. The findings should not be used for clinical or public health decision-making or presented without highlighting these facts. For more information, please see the FAQs.
Safety and Feasibility of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Locally Advanced Upper Third Gastric Cancer: A Phase II Prospective, Multi-Institution Clinical Trial (CLASS-04)
151 Pages Posted: 19 Sep 2018
More...Abstract
Background: Previous retrospective studies have shown that laparoscopic spleen-preserving D2 total gastrectomy (LSTG) for advanced upper third gastric cancer (AUTGC) is safe. However, all previous studies were underpowered. We therefore conducted a prospective, multicenter, single-arm, phase II study to evaluate the feasibility of LSTG in patients with AUTGC.
Methods: Between September 2016 and October 2017, 251 patients with newly diagnosed AUTGC (cT2-4a, N-/ , M0) underwent LSTG at 19 institutions. The primary endpoint was complication within 30 days of surgery. Postoperative outcomes were also investigated, including the number of No. 10 lymph node (LN) dissections, metastasis rates of No.10 LNs, and intraoperative complications.
Findings: A total of 251 patients were enrolled in the study, and 242 patients were eligible for the per protocol (PP) analysis. The average numbers of No. 10 LN dissections and metastases were 2.38 and 0.12, respectively; 18 patients (7.4%) had No. 10 LN metastases, and among patients with advanced gastric cancer, the rate of No. 10 LN metastasis was 8.1% (18/223). A pN3 status was an independent risk factor for No. 10 LN metastasis. Intraoperative complications occurred in 7 patients, but no cases were converted to open surgery or underwent splenectomy. The overall postoperative complication rate was 13.6% (33/242). The major complication and mortality rates were 3.3% (8/242) and 0.4% (1/242), respectively. The number of retrieved No. 10 LNs, No. 10 LN metastasis and p-stage showed no significant influence on postoperative complication rates. Interpretation: LSTG for AUTGC was safe and effective when conducted by experienced surgeons. Further phase III randomized controlled trials are warranted to validate its long-term significance.
Trial Registration Number: The study was registered at ClinicalTrials.gov as NCT02845986.
Funding: The study was sponsored by the Scientific and technological innovation joint capital projects of Fujian Province (2016Y9031); Construction Project of Fujian Province Minimally Invasive Medical Center (No.[2017]171); The second batch of special support funds for Fujian Province innovation and entrepreneurship talents (2016B013); Chinese physicians association young physician respiratory research fund of Fujian province medical innovation project (2015-CXB-16).
Declaration of Interest: We declare no competing interests.
Ethical Approval: the study was approved by the institutional review boards of all participating hospitals. All investigators conducted this study in accordance with the Declaration of Helsinki. Written informed consent was obtained before patients were recruited.
Suggested Citation: Suggested Citation