Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer

NCT04443478 | Recruiting DMC

• 1 other identifier: CLASS-10
• Study Type: observational
• Target: 1,036
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The number of lower mediastinal lymph nodes retrieved

  The number of lower mediastinal lymph nodes retrieved

  immediately after the pathology report issued

Secondary Outcomes (13)

• Rate of complication during Lower Mediastinal Lymphadenectomy

  immediately after the surgery

• Rate of postoperative complication after Lower Mediastinal Lymphadenectomy

  Day 30 after surgery

• Time length of Lower Mediastinal Lymphadenectomy

  immediately after the surgery

• Rate of Postoperative complication

  Day 30 after surgery

• Rate of postoperative death

  Day 30 after surgery

Other Outcomes (4)

• Quality evaluation index of Lower Mediastinal Lymphadenectomy

  through study completion, an average of 3 years

• Learning curve of Lower Mediastinal Lymphadenectomy

  through study completion, an average of 3 years

• Treatment tendency of surgeons and patients

  through study completion, an average of 3 years

Study Arms (2)

Laparoscopic Surgery

Lower Mediastinal Lymphadenectomy should be finished via laparoscopic method.

Procedure: Radical gastrectomy with dissection of lower mediastinal lymph node

Open Surgery

Lower Mediastinal Lymphadenectomy should be finished via open method.

Procedure: Radical gastrectomy with dissection of lower mediastinal lymph node

Interventions

Radical gastrectomy with dissection of lower mediastinal lymph node PROCEDURE

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

Laparoscopic Surgery; Open Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University: lead
• Peking University Cancer Hospital & Institute: collaborator
• Changzhi People's Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Fudan University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The First Hospital of Jilin University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The First Affiliated Hospital of Air Force Medicial University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Shandong Provincial Hospital: collaborator
• Shanxi Province Cancer Hospital: collaborator
• RenJi Hospital: collaborator
• Ruijin Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• West China Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (12)

• Bray 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 BACKGROUND

• Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.

  PMID: 8180768 BACKGROUND

• Markar 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 BACKGROUND

• Kim 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 BACKGROUND

• Hu 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 BACKGROUND

• Yu 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.

  PMID: 31135850 BACKGROUND

• Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.

  PMID: 32060757 BACKGROUND

• Kurokawa Y, Takeuchi H, Doki Y, Mine S, Terashima M, Yasuda T, Yoshida K, Daiko H, Sakuramoto S, Yoshikawa T, Kunisaki C, Seto Y, Tamura S, Shimokawa T, Sano T, Kitagawa Y. Mapping of Lymph Node Metastasis From Esophagogastric Junction Tumors: A Prospective Nationwide Multicenter Study. Ann Surg. 2021 Jul 1;274(1):120-127. doi: 10.1097/SLA.0000000000003499.

  PMID: 31404008 BACKGROUND

• Sugita S, Kinoshita T, Kaito A, Watanabe M, Sunagawa H. Short-term outcomes after laparoscopic versus open transhiatal resection of Siewert type II adenocarcinoma of the esophagogastric junction. Surg Endosc. 2018 Jan;32(1):383-390. doi: 10.1007/s00464-017-5687-6. Epub 2017 Jun 27.

  PMID: 28656339 BACKGROUND

• Sugita S, Kinoshita T, Kuwata T, Tokunaga M, Kaito A, Watanabe M, Tonouchi A, Sato R, Nagino M. Long-term oncological outcomes of laparoscopic versus open transhiatal resection for patients with Siewert type II adenocarcinoma of the esophagogastric junction. Surg Endosc. 2021 Jan;35(1):340-348. doi: 10.1007/s00464-020-07406-w. Epub 2020 Feb 5.

  PMID: 32025923 BACKGROUND

• Huang CM, Lv CB, Lin JX, Chen QY, Zheng CH, Li P, Xie JW, Wang JB, Lu J, Cao LL, Lin M, Tu RH. Laparoscopic-assisted versus open total gastrectomy for Siewert type II and III esophagogastric junction carcinoma: a propensity score-matched case-control study. Surg Endosc. 2017 Sep;31(9):3495-3503. doi: 10.1007/s00464-016-5375-y. Epub 2016 Dec 15.

  PMID: 27981384 BACKGROUND

• Li S, Ying X, Shan F, Jia Y, Li Z, Xue K, Miao R, Wang Y, Bu Z, Su X, Li Z, Ji J. 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). Chin J Cancer Res. 2022 Aug 30;34(4):406-414. doi: 10.21147/j.issn.1000-9604.2022.04.08.

  PMID: 36199536 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Cancer Hospital

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2023
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the publication.

Locations

CN (1)