Clinical trial NCT04443478: Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer
Official title: Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Siewert Type II/III Adenocarcinoma of Esophagogastric Junction: an Exploratory, Prospective, Observational, IDEAL Stage 2, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Keywords: esophagogastric junction
lower mediastinal lymphadenectomy
laparoscopic gastrectomy
IDEAL framework
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Changzhi People's Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: Fujian Medical University Union Hospital
name: Shanghai Zhongshan Hospital
name: Fudan University
name: Guangdong Provincial People's Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Hebei Medical University Fourth Hospital
name: Wuhan Union Hospital, China
name: The First Hospital of Jilin University
name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of Air Force Medicial University
name: Nanfang Hospital, Southern Medical University
name: The Affiliated Hospital of Qingdao University
name: Affiliated Hospital of Qinghai University
name: The First Affiliated Hospital of Xiamen University
name: Shandong Provincial Hospital
name: Shanxi Province Cancer Hospital
name: RenJi Hospital
name: Ruijin Hospital
name: Beijing Friendship Hospital
name: West China Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Zhejiang Cancer Hospital
name: Chinese PLA General Hospital
name: First Hospital of China Medical University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Sun Yat-sen University
First posted: 2020-06-23
Enrollment: 1036
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologically Confirmed esophageal gastric adenocarcinoma, clinical stage cT2-4aN3M0(AJCC - 8th gastric cancer tumor TNM staging), Siewert Ⅱ/Ⅲ, receive surgical treatment without preoperative treatment.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The number of lower mediastinal lymph nodes retrieved
timeFrame: immediately after the pathology report issued
Secondary outcomes:
measure: Rate of complication during Lower Mediastinal Lymphadenectomy
timeFrame: immediately after the surgery
measure: Rate of postoperative complication after Lower Mediastinal Lymphadenectomy
timeFrame: Day 30 after surgery
measure: Time length of Lower Mediastinal Lymphadenectomy
timeFrame: immediately after the surgery
measure: Rate of Postoperative complication
timeFrame: Day 30 after surgery
measure: Rate of postoperative death
timeFrame: Day 30 after surgery
measure: Rate of unscheduled reoperation
timeFrame: Day 30 after surgery
measure: Rate of unscheduled readmission
timeFrame: Day 30 after surgery
measure: R0 resection rate
timeFrame: immediately after the pathology report issued
measure: Proximal margin length
timeFrame: 30minutes after removal of tumor
measure: Local recurrence of lower mediastinal area in 3 years
timeFrame: Year 3 after surgery
measure: Rate of cancer specific death in 3 years
timeFrame: Year 3 after surgery
measure: Recurrence free survival in 3 years
timeFrame: Year 3 after surgery
measure: Overall survival in 3 years
timeFrame: Year 3 after surgery
Other outcomes:
measure: Quality evaluation index of Lower Mediastinal Lymphadenectomy
timeFrame: through study completion, an average of 3 years
measure: Learning curve of Lower Mediastinal Lymphadenectomy
timeFrame: through study completion, an average of 3 years
measure: Treatment tendency of surgeons and patients
timeFrame: through study completion, an average of 3 years
measure: Number of patients that can be screened and successfully recruited
timeFrame: through study completion, an average of 3 years
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
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