跳至主要内容
临床试验/NCT02981810
NCT02981810Unknown不适用

Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.

Hillel Yaffe Medical Center0 个研究点目标入组 120 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
Change in the number of visits at the doctor due to throat pain- using a questionnaire

研究概览

简要总结

To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation can create changing in the tonsillar medium for recurrent tonsillar infections and stop the recurrent infections?

详细描述

The palatine tonsil consists of an epithelial crypt (invaginated pocket) surrounded by dense clusters of lymph nodules, each with a germinal center where lymphocytes proliferate. The nodules are embedded in a mass of diffuse lymphoid tissue that consists of lymphocytes migrating to and from the germinal centers.

Increasing the surface area of the crypts is one way to facilitate the contact of antigens (bacteria) with the immune cells. The epithelium may specialize to form an openmeshwork of cells which allows the infiltration of the epithelium by lymphocytes and macrophages. Tonsillar lymphoid nodules consist mainly of B-lymphocytes. Other areas are occupied by T-lymphocytes, activated B-lymphocytes and other cells of the immune system. Inside the crypts, where cells of the immune system often invade the epithelium, it will be difficult to find the specific boundary between epithelium and lymphoid tissue. The bacterial material and biofilms1 sits in crypts and may start a new infection from time to time. The epithelium lining the crypt corresponds with that on the adjacent surface - stratified squamous in the tongue and palate or pseudo stratified columnar in the pharynx. In either case, the epithelium may be heavily infiltrated with lymphocytes, and the crypt may be filled with lymphocytes and other debris.

The tonsillar crypts have an important role in chronic tonsillitis. They are covered by stratified epithelium and may be initiated via the epithelium to mount immune responses to various presenting antigens. Go M. et al, investigated the expression and function of tight junctions in the epithelium of human palatine tonsils from patients with tonsillar hypertrophy or recurrent tonsillitis. These studies suggested unique expression of tight junctions in human palatine tonsillar epithelium, and it was suggested that the crypt epithelium may possess an epithelial barrier different from that of the surface epithelium2.

Bacteria within biofilms are resistant to host defenses and antibiotics. The presence of bacterial biofilms within the tissue and crypts of inflamed tonsils may explain the chronic and recurrent characteristics of some forms of tonsillitis. There is strong anatomical evidence for the presence of bacterial biofilms in chronically diseased tonsils1. Using a novel visualization approach in single sections of human mucosal tissue, the presence of biofilms was demonstrated on tonsils in most (17/24 [70.8%]) patients with tonsillitis3.

One study investigated the difference in follicle size and numbers in tonsils for patients with tonsillar hypertrophy and recurrent tonsillitis using an image analysis method. There was no significant difference in the mean follicle numbers per counting field between recurrent tonsillitis and tonsillar hypertrophy. However, they demonstrated that tonsillar hypertrophy is characterized histologically by an enlargement of follicles compared with recurrent tonsillitis, indicating a hyperplastic condition of lymphoid cells in the germinal centers. It may also explain the difference in etiology and immune mechanism between tonsillar hypertrophy and recurrent tonsillitis4.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients without any chronic diseases other than chronic tonsillitis. Diagnosis of chronic tonsillitis is based on history and medical examination. The criteria are:
  • At least 3 occasions of tonsillitis in the last year that were treated (positive throat swab for Streptococci Group A will contribute towards the diagnosis).
  • Recurrent or chronic throat pain.
  • Hypertrophic tonsils of chronic tonsillitis.

排除标准

  • Disease of the mouth or pharyngeal mucosa-like ulcers.
  • Allergy to drugs.
  • Gastrointestinal reflux.
  • Peritonsillar abscess in the past.
  • Pregnant women
  • Oncologic patients
  • Hematologic disease

结局指标

主要结局

Change in the number of visits at the doctor due to throat pain- using a questionnaire

时间窗: 12 months

the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

Change in the number of antibiotic treatment was indicated after the procedure- using a questionnaire

时间窗: 12 month

the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

questionnaires to subjectively evaluate the change in patient's discomfort while swallowing

时间窗: 12 month

the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

visual documentation of the pharynx with video camera

时间窗: 12 month

次要结局

  • post operative pain assessment via VAS (VISUAL ANALOG SCALE) scores(up to 7 days)
  • location and amount of bleeding- post surgical documentation(up to 7 days)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Itzhak Braverman

Assitant Proffessor

Hillel Yaffe Medical Center

相似试验