The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma

NCT05323929 | Recruiting

• 1 other identifier: 2021-0634
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, prospective, group-controlled clinical trial, aiming to clarify the relationship between the depth of dissection and scar formation in the treatment of early gastric cancer by ESD, and to provide high-quality evidence-based medicine for the treatment of early gastric cancer.

Conditions

Early Gastric Cancer; Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• scar area

  the scar area after ESD for 1 year

  1 year

Study Arms (2)

deep ESD group

EXPERIMENTAL

Performed according to the ESD standard procedure, the depth of dissection includes the SM3 layer (submucosa 1/3 layer)

Procedure: ESD

shallow ESD group

EXPERIMENTAL

Performed according to the ESD standard procedure, the depth of dissection does not include the SM3 layer (submucosa 1/3 layer)

Procedure: ESD

Interventions

ESD PROCEDURE

Endoscopic Submucosal Dissection for early gastric cancer

deep ESD group; shallow ESD group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old and younger than 75 years old.
• Early gastric cancer (T1a stage) diagnosed by gastroscopy or ultrasonography, differentiated and no ulcer; or early gastric cancer (T1a stage), differentiated with ulcer, lesion diameter \<3cm; or early gastric cancer (T1a stage), undifferentiated and No ulcer, lesion diameter \<2cm.
• Pathological diagnosis of gastric cancer.
• No further treatment is required.
• Patients diagnosed for the first time without other serious gastrointestinal diseases.

You may not qualify if:

• Those who did not comply with the test requirements, obviously violated this protocol, or switched to other protocols in the middle of treatment.
• Advanced gastric cancer; or undifferentiated gastric cancer lesions \> 2 cm in diameter; or differentiated gastric cancer with ulcer lesions \> 3 cm in diameter.
• Coagulation disorders.
• Serious heart, liver, kidney and other diseases, can not tolerate ESD treatment.
• Patients with gastric cancer complications such as gastrointestinal bleeding and perforation that need emergency treatment.
• Patients with distant metastasis.
• Patients with other tumors, patients with a history of malignant tumors (except early carcinoma in situ.
• The patient himself requests to withdraw from the trial.
• The researcher believes that the patient is not suitable to participate in this study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated hospital, school of medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (6)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Russo AE, Strong VE. Gastric Cancer Etiology and Management in Asia and the West. Annu Rev Med. 2019 Jan 27;70:353-367. doi: 10.1146/annurev-med-081117-043436. Epub 2018 Oct 24.

  PMID: 30355265 BACKGROUND

• Tsukuma H, Oshima A, Narahara H, Morii T. Natural history of early gastric cancer: a non-concurrent, long term, follow up study. Gut. 2000 Nov;47(5):618-21. doi: 10.1136/gut.47.5.618.

  PMID: 11034575 BACKGROUND

• Toyonaga T, Man-i M, East JE, Nishino E, Ono W, Hirooka T, Ueda C, Iwata Y, Sugiyama T, Dozaiku T, Hirooka T, Fujita T, Inokuchi H, Azuma T. 1,635 Endoscopic submucosal dissection cases in the esophagus, stomach, and colorectum: complication rates and long-term outcomes. Surg Endosc. 2013 Mar;27(3):1000-8. doi: 10.1007/s00464-012-2555-2. Epub 2012 Oct 6.

  PMID: 23052530 BACKGROUND

• Ono H, Yao K, Fujishiro M, Oda I, Uedo N, Nimura S, Yahagi N, Iishi H, Oka M, Ajioka Y, Fujimoto K. Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer (second edition). Dig Endosc. 2021 Jan;33(1):4-20. doi: 10.1111/den.13883. Epub 2020 Dec 9.

  PMID: 33107115 BACKGROUND

• Chung IK, Lee JH, Lee SH, Kim SJ, Cho JY, Cho WY, Hwangbo Y, Keum BR, Park JJ, Chun HJ, Kim HJ, Kim JJ, Ji SR, Seol SY. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc. 2009 Jun;69(7):1228-35. doi: 10.1016/j.gie.2008.09.027. Epub 2009 Feb 27.

  PMID: 19249769 BACKGROUND

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 Officials

• Xinliang Lu, professor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Yuqi Wang, Doctor

CONTACT

+86-15267019821; wyq@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)