Clinical trial · Observational

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

NCT04443478CI-TRIAL-00055330unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Radical gastrectomy with dissection of lower mediastinal lymph node	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Laparoscopic Surgery
description
Lower Mediastinal Lymphadenectomy should be finished via laparoscopic method.
interventionNames
1. Procedure: Radical gastrectomy with dissection of lower mediastinal lymph node
label
Open Surgery
description
Lower Mediastinal Lymphadenectomy should be finished via open method.
interventionNames
1. Procedure: Radical gastrectomy with dissection of lower mediastinal lymph node

Primary outcomes (1)

measure
The number of lower mediastinal lymph nodes retrieved
timeFrame
immediately after the pathology report issued
description
The number of lower mediastinal lymph nodes retrieved

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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).

References

Publications (12)

BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
BACKGROUNDKitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. PMID 8180768
BACKGROUNDMarkar SR, Dabakuyo-Yonli TS, Piessen G. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. Reply. N Engl J Med. 2019 Apr 25;380(17):e28. doi: 10.1056/NEJMc1901650. No abstract available. PMID 31018084
BACKGROUNDKim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346. PMID 26352529
BACKGROUNDHu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22. PMID 26903580
BACKGROUNDYu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.

Registry

Dates and enrollment