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Gastric CancerNCT04443478

Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer

An observational study of Gastric Cancer, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
Radical gastrectomy with dissection of lower mediastinal lymph node
Type of treatment
Surgery or procedure
How many people
1,036 participants
Where
1 siteChina
Study dates
1 Aug 2020to 1 Jul 2026
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Fei Shan, MD, 010-88196598, shanfei@hsc.pku.edu.cn

    Zhemin Li, MD, 010-88196598, tagzhemin@outlook.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Gastric Cancer
Being tested
Radical gastrectomy with dissection of lower mediastinal lymph node
Keywords
esophagogastric junction, lower mediastinal lymphadenectomy, laparoscopic gastrectomy, IDEAL framework
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radical gastrectomy with dissection of lower mediastinal lymph nodeProcedure or surgery

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

Study groups in NCT04443478
Study groupRoleWhat they receive
Laparoscopic SurgeryLower Mediastinal Lymphadenectomy should be finished via laparoscopic method.
Receives: Procedure: Radical gastrectomy with dissection of lower mediastinal lymph node
Open SurgeryLower Mediastinal Lymphadenectomy should be finished via open method.
Receives: Procedure: Radical gastrectomy with dissection of lower mediastinal lymph node

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of lower mediastinal lymph nodes retrieved

    The number of lower mediastinal lymph nodes retrieved

    Measured: immediately after the pathology report issued

Secondary outcomes (13)

  1. Rate of complication during Lower Mediastinal Lymphadenectomy

    Complication during Lower Mediastinal Lymphadenectomy \& anastomosis, including damage of pericardium, esophagus, etc.

    Measured: immediately after the surgery

  2. Rate of postoperative complication after Lower Mediastinal Lymphadenectomy

    Postoperative complication after Lower Mediastinal Lymphadenectomy, including leakage, bleeding, etc, complication related with Lower Mediastinal Lymphadenectomy

    Measured: Day 30 after surgery

  3. Time length of Lower Mediastinal Lymphadenectomy

    Time length of Lower Mediastinal Lymphadenectomy

    Measured: immediately after the surgery

  4. Rate of Postoperative complication

    Any complication within 30d after surgery

    Measured: Day 30 after surgery

  5. Rate of postoperative death

    death within 30 days after surgery

    Measured: Day 30 after surgery

  6. Rate of unscheduled reoperation

    reoperation within 30 days after surgery

    Measured: Day 30 after surgery

  7. Rate of unscheduled readmission

    unscheduled readmission within 30 days after surgery

    Measured: Day 30 after surgery

  8. R0 resection rate

    R0 resection rate

    Measured: immediately after the pathology report issued

  9. Proximal margin length

    from proximal tumor margin to proximal margin

    Measured: 30minutes after removal of tumor

  10. Local recurrence of lower mediastinal area in 3 years

    Local recurrence of lower mediastinal area in 3 years

    Measured: Year 3 after surgery

  11. Rate of cancer specific death in 3 years

    Rate of cancer specific death in 3 years

    Measured: Year 3 after surgery

  12. Recurrence free survival in 3 years

    Recurrence free survival in 3 years

    Measured: Year 3 after surgery

  13. Overall survival in 3 years

    Overall survival in 3 years

    Measured: Year 3 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,036 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04443478
Sponsor's protocol ID
CLASS-10
Status last verified
Nov 2021
First submitted
17 Jun 2020
Last updated
2 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared after the publication of the results.

Publications

  • 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.

    PubMed 30207593

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

    PubMed 8180768

  • 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.

    PubMed 31018084

  • 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.

    PubMed 26352529

  • 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.

    PubMed 26903580

  • 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.

    PubMed 31135850

  • 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.

    PubMed 32060757

  • 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.

    PubMed 31404008

  • 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.

    PubMed 28656339

  • 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.

    PubMed 32025923

  • 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.

    PubMed 27981384

  • 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.

    PubMed 36199536

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of lower mediastinal lymph nodes retrieved (time frame: immediately after the pathology report issued). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04443478, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.

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