Dataset Information

Laparoscopic vs. open lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction: An exploratory, observational, prospective, IDEAL stage 2b cohort study (CLASS-10 study).

ABSTRACT:

Objective

This study aims to verify the feasibility and efficacy of laparoscopic lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction (AEG).

Setting

An exploratory, observational, prospective, cohort study will be carried out under the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) framework (stage 2b).

Participants

The study will recruit 1,036 patients with cases of locally advanced AEG (Siewert type II/III, clinical stage cT2-4aN0-3M0), and 518 will be assigned to either the laparoscopy group or the open group.

Interventions

Patients will receive lower mediastinal lymphadenectomy along with either total or proximal gastrectomy.

Primary and secondary outcome measures

The primary endpoint is the number of lower mediastinal lymph nodes retrieved, and the secondary endpoints are the surgical safety and prognosis, including intraoperative and postoperative lower-mediastinal-lymphadenectomy-related morbidity and mortality, rate of rehospitalization, R0 resection rate, 3-year local recurrence rate, and 3-year overall survival.

Conclusions

The study will provide data for the guidance and development of surgical treatment strategies for AEG.

Trial registration number

The study has been registered in ClinicalTrials.gov (No. NCT04443478).

SUBMITTER: Li S

PROVIDER: S-EPMC9468012 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Laparoscopic <i>vs</i>. open lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction: An exploratory, observational, prospective, IDEAL stage 2b cohort study (CLASS-10 study).

Li Shuangxi S Ying Xiangji X Shan Fei F Jia Yongning Y Li Zhemin Z Xue Kan K Miao Rulin R Wang Yinkui Y Bu Zhaode Z Su Xiangqian X Li Ziyu Z Ji Jiafu J

Chinese journal of cancer research = Chung-kuo yen cheng yen chiu 20220801 4

<h4>Objective</h4>This study aims to verify the feasibility and efficacy of laparoscopic lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction (AEG).<h4>Setting</h4>An exploratory, observational, prospective, cohort study will be carried out under the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) framework (stage 2b).<h4>Participants</h4>The study will recruit 1,036 patients with cases of locally advanced AEG (Siewert ty ...[more]

PMID: 36199536

Similar Datasets

Project description:ObjectiveTo compare the prognostic factors of Siewert type II AEG patients who had received neoadjuvant radiotherapy (nRT) versus those who did not receive nRT. Nomograms for outcome prediction were constructed for the two treatment modalities.Materials and methodsData for 1,745 Siewert II type AEG patients who underwent radical surgery between 2010 and 2015 were retrieved from SEER (Surveillance, Epidemiology, and End Results) database. Patients were assigned to neoadjuvant radiotherapy (nRT) and non-neoadjuvant radiotherapy (non-nRT) groups based on treatment modality. Independent prognostic predictors were used to develop nomograms. Concordance index (C-index), receiver operating characteristic (ROC), calibration curves, and decision curve analyses (DCA) were used to determine the performance and prognostic value of the nomograms. The predictive accuracy of nomograms was compared with the prognostic value of the Tumor-Node-Metastasis (TNM) staging system.ResultsThe results showed that age, lymph node rate (LNR), and the number of removed lymph nodes (RLN) were independent prognostic factors for CSS in the nRT group. Tumor size, tumor grade, T stage, LNR, and therapy type were independent prognosis factors for CSS in patients in the non-nRT group. The C-indices for the nomograms were 0.652 (95% CI, 0.614-0.690) and 0.663 (95% CI, 0.606-0.720) in the training and validation cohort, respectively, for the nRT group. C-indices for the nomogram in non-nRT group were 0.754 (95% CI, 0.723-0.785) and 0.747 (95% CI, 0.688-0.800) for the training and validation cohorts, respectively. C-indices and ROC curves showed good predictive value compared with the TNM staging system in both groups. C-indices, as well as the AUC values of the nomograms and the TNM staging system for both cohorts in the non-nRT group were higher compared with those in the nRT group. Analysis of the survival calibration curve revealed high consistency between actual versus predicted outcomes determined by the nomograms. Decision curve analyses revealed that the new models had higher prediction value and clinical significance compared with TNM staging system.ConclusionThe established nomograms showed high prognostic value for Siewert type II AEG patients in both nRT and non-nRT groups. In addition, the nomogram and the TNM staging systems showed better prognostic performance for patients in the non-nRT group compared with patients in the nRT group.