Viewing Study NCT06418945



Ignite Creation Date: 2024-05-19 @ 5:33 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06418945
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-17
First Post: 2024-05-13

Brief Title: Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery
Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Organization: The First Affiliated Hospital of Henan University of Science and Technology

Study Overview

Official Title: Porphyromonas Gingivalis Elimination From Oral Improves Esophageal Cancer Patients Survival After Radical Operation
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Esophagectomy is an important means of radical treatment of esophageal cancer but due to local recurrence and metastasis the 5-year survival rate of patients with esophageal cancer is only 20-30 Studies have reported that about 50 of patients relapse within 1 year after surgery and the short-term recurrence rate is high Therefore reducing the recurrence rate of esophageal cancer after operation is an important way to improve its prognosis Porphyromonas gingivalis infection in ESCC tissues was significantly higher than that in paracancer tissues and was significantly positively correlated with cancer cell differentiation lymph node metastasis TNM stage and shortened survival of ESCC patients In summary porphyromonas gingivalis plays an important role in postoperative recurrence of esophageal cancer Elimination of porphyromonas gingivalis can significantly reduce the recurrence rate of esophageal cancer after operation Tinidazole is a class of nitroimidazole drugs It has been pointed out that the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria so as to eliminate bacteria in periodontal tissues and inhibit local inflammation Based on this we designed and fabricated a novel oral microneedle patch loaded with tinidazole Tinidazole oral microneedle patch can effectively remove porphyromonas gingivalis and promote the repair of gingival tissue In this study based on the combination of mechanical removal and antibacterial treatment a combination of ultrasonic dental cleaning and tinidazole oral composite microneedle patch was designed to completely remove porphyromonas gingivalis in oral cavity and to evaluate the effect of removal of porphyromonas gingivalis in oral cavity on the prognosis of esophageal cancer after radical surgery
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None