Clinical trial NCT05323929: 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
Overall status: RECRUITING
Phase: NA
Conditions: Early Gastric Cancer
Endoscopic Submucosal Dissection
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: scar area
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated hospital, school of medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xinliang Lu, professor
role: STUDY_DIRECTOR
References:
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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.
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.
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.