Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer

Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Siewert Type II/III Adenocarcinoma of Esophagogastric Junction: an Exploratory, Prospective, Observational, IDEAL Stage 2, Cohort Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04443478

Enrollment

1036

Registered

2020-06-23

Start date

2020-08-01

Completion date

2026-07-01

Last updated

2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

esophagogastric junction, lower mediastinal lymphadenectomy, laparoscopic gastrectomy, IDEAL framework

Brief summary

Mediastinal lymph node dissection has been adopted as standard treatment for adenocarcinoma of esophagogastric junction(AEJ). This multi-center, exploratory, prospective, cohort study aims at provide standard technical details of laparoscopic mediastinal lymph node dissection, and explore the potential clinical effects, gather key information for following study regarding sample size calculation, primary outcome and feasibility.

Detailed description

Introduction: Lower mediastinal lymph node dissection has been adopted as standard by treatment guideline for adenocarcinoma of esophagogastric junction(AEJ), but the effect of laparoscopic mediastinal lymph node dissection remains unknown. The aim of this study is to provide standard technical details of laparoscopic mediastinal lymph node dissection, and explore the potential clinical effects, gather key information for following study regarding sample size calculation, primary outcome and feasibility. This study report intervention development, governance procedures and selection and reporting of outcomes to optimize methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice. Methods and analysis: This is an IDEAL stage II, prospective, parallel control, open label, multi-center and exploratory study. The inclusion criteria is Siewert II/ III, AEJ, cT2-4aN0-3M0(AJCC-8th Gastric Cancer TNM stage manual), decide to receive radical gastrectomy, without preoperative anti-neoplastic therapy. The individual included in the study is performed the radical total or proximal gastrectomy plus the lower mediastinal lymphadenectomy via either laparoscopic (trial arm) or open (control arm) TH approach. The surgical approach is determined by the investigator in each center before the operation and recorded in the electronic case report forms (CRF). The primary outcome is the number of lower mediastinal lymph nodes retrieved. Secondary outcome include complication, surgery length, postoperative death, R0 resection rate, etc. Expected sample size is 518 in each group, thus has 80% power to detect a difference of 0.17 in the average number of lower mediastinal lymph node dissected in between two groups.

Interventions

PROCEDURERadical gastrectomy with dissection of lower mediastinal lymph node

Radical gastrectomy for gastric cancer should be consistent with Japanese gastric cancer treatment guideline.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18-80 years old; * Karnofsky score ≥70%;Or ECOG score ≤2; * Preoperative pathological biopsy confirmed adenocarcinoma. * According to gastroscopy, abdominal CT or upper gastrointestinal angiography, the tumor site conforms to the definition of esophageal and gastric junction adenocarcinoma in the Chinese expert consensus, that is, the tumor center is within 5cm above and below the esophagogastric anatomical junction and crosses or touches the esophagogastric junction; * Length of esophageal invasion ≤2cm; * By abdominal contrast-enhanced CT/MRI, the clinical stage was CT2-4aN0-3M0 (according to AJCC-8th TNM tumor stage); * Subject's blood routine and biochemical indicators meet the following standards: hemoglobin ≥80g/L; Absolute count of neutrophils (ANC) ≥1.5×109/L; Platelet ≥75×109/L;ALT and AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper limit; Serum total bilirubin ≤1.5 times the normal upper limit; Serum creatinine ≤ the normal upper limit; Serum albumin ≥30g/L; * Obtain written informed consent.

Exclusion criteria

* Any anti-cancerous treatment received prior to surgery. * Multiple malignant lesions in the stomach. * Suspicious lymph node metastasis in the middle and/or upper mediastinum. * Surgical history in the upper abdomen (laparoscopic cholecystectomy excluded). * Pregnant or breastfeeding women. * Uncontrolled epilepsy, central nervous system disease or mental disorder. * The Bulky N2 status. * The emergency surgery. * Severe heart disease. * History of cerebral infarction or cerebral hemorrhage within 6 months. * Organ transplant recipients who need immunosuppressive therapies. * Other malignancy diagnosed within 5 years (cured dermoid caner and cervical cancer excluded).

Design outcomes

Primary

Measure	Time frame	Description
The number of lower mediastinal lymph nodes retrieved	immediately after the pathology report issued	The number of lower mediastinal lymph nodes retrieved

Secondary

Measure	Time frame	Description
Overall survival in 3 years	Year 3 after surgery	Overall survival in 3 years
Proximal margin length	30minutes after removal of tumor	from proximal tumor margin to proximal margin
Local recurrence of lower mediastinal area in 3 years	Year 3 after surgery	Local recurrence of lower mediastinal area in 3 years
Rate of cancer specific death in 3 years	Year 3 after surgery	Rate of cancer specific death in 3 years
Recurrence free survival in 3 years	Year 3 after surgery	Recurrence free survival in 3 years
Rate of complication during Lower Mediastinal Lymphadenectomy	immediately after the surgery	Complication during Lower Mediastinal Lymphadenectomy & anastomosis, including damage of pericardium, esophagus, etc.
Rate of postoperative complication after Lower Mediastinal Lymphadenectomy	Day 30 after surgery	Postoperative complication after Lower Mediastinal Lymphadenectomy, including leakage, bleeding, etc, complication related with Lower Mediastinal Lymphadenectomy
Time length of Lower Mediastinal Lymphadenectomy	immediately after the surgery	Time length of Lower Mediastinal Lymphadenectomy
Rate of Postoperative complication	Day 30 after surgery	Any complication within 30d after surgery
Rate of postoperative death	Day 30 after surgery	death within 30 days after surgery
Rate of unscheduled reoperation	Day 30 after surgery	reoperation within 30 days after surgery
Rate of unscheduled readmission	Day 30 after surgery	unscheduled readmission within 30 days after surgery
R0 resection rate	immediately after the pathology report issued	R0 resection rate

Other

Measure	Time frame	Description
Learning curve of Lower Mediastinal Lymphadenectomy	through study completion, an average of 3 years	refers to the number of surgical cases corresponding to the transition point
Treatment tendency of surgeons and patients	through study completion, an average of 3 years	the proportion of persons willing to receive treatment in randomization
Number of patients that can be screened and successfully recruited	through study completion, an average of 3 years	The number of patients that can be screened, excluded, successfully recruited, intervented, and followed up throughout each phase of the study.
Quality evaluation index of Lower Mediastinal Lymphadenectomy	through study completion, an average of 3 years	surgical characteristics that are directly related to the safety outcome of surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026