Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe First Affiliated Hospital of Henan University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-85 years old

Histologically confirmed esophageal cancer

Patients undergoing radical resection for esophageal cancer who do not require or are not eligible for radiotherapy,T1-T4N0-3M0

ECOG:0~1

Disqualifiers

Does not meet the above inclusion criteria

Patients with distant visceral metastases

Patients requiring adjuvant radiotherapy after neoadjuvant radiotherapy or radical surgery

Allergic to tinidazole or metabolic disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tinidazole oral microneedle patch

    Combination product

    Ultrasonic teeth cleaning: After gargling with compound chlorhexidine gargle or 3% hydrogen peroxide gargle for 1 minute, the teeth were cleaned by ultrasonic wave. After the teeth were cleaned, the wound was rinsed with 3% hydrogen peroxide to stop bleeding. Immediately after the ultrasonic cleaning, two pieces of tinidazole oral composite microneedle patch were applied to the upper and lower gums close to the inside of the first molar, especially on the tooth loss or damage, and the mouth was kept closed for 15 minutes. After the microneedle was fully degraded, the room could be left.

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Arm 1:pg(-)No intervention 0 interventions
Group B: Arm 2:pg(+)Experimental treatment 1 intervention
Group C: Arm 3:pg(+)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

DFS

Disease-free survival

Time frame
5 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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