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

Primary Purpose

Early Gastric Cancer, Endoscopic Submucosal Dissection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ESD
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Early Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Second affiliated hospital, school of medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

deep ESD group

shallow ESD group

Arm Description

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

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

Outcomes

Primary Outcome Measures

scar area
the scar area after ESD for 1 year

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
April 12, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05323929
Brief Title
The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
Official Title
The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This project intends to compare the scar size of ESD for early gastric cancer with different peeling depths, explore the relationship between ESD peeling depth, scar formation and gastric function, and clarify the differential impact of different peeling depths on the prognosis of patients. We plan to provide evidence for guidelines of early gastric cancer ESD treatment based on the related data. In further, the project show insight into a more effective clinical technique which profit patients better prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer, Endoscopic Submucosal Dissection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
deep ESD group
Arm Type
Experimental
Arm Description
Performed according to the ESD standard procedure, the depth of dissection includes the SM3 layer (submucosa 1/3 layer)
Arm Title
shallow ESD group
Arm Type
Experimental
Arm Description
Performed according to the ESD standard procedure, the depth of dissection does not include the SM3 layer (submucosa 1/3 layer)
Intervention Type
Procedure
Intervention Name(s)
ESD
Intervention Description
Endoscopic Submucosal Dissection for early gastric cancer
Primary Outcome Measure Information:
Title
scar area
Description
the scar area after ESD for 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqi Wang, Doctor
Phone
+86-15267019821
Email
wyq@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinliang Lu, professor
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Second affiliated hospital, school of medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuqi Wang, Doctor
Phone
+86-15267019821
Email
wyq@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33538338
Citation
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.
Results Reference
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PubMed Identifier
30355265
Citation
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.
Results Reference
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PubMed Identifier
11034575
Citation
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.
Results Reference
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PubMed Identifier
23052530
Citation
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.
Results Reference
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PubMed Identifier
33107115
Citation
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.
Results Reference
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PubMed Identifier
19249769
Citation
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.
Results Reference
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The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma

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