NCT00587600已完成2 期
Biomarkers in Phototherapy of Barrett's Esophagus
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- The primary assessment for our first specific aim will be to determine the effect of photodynamic therapy on biomarkers after photodynamic therapy.
研究概览
简要总结
This study is being done to find out if Photodynamic Therapy (treatment with a red light and a drug called photofrin) or Radiofrequency ablation works the same for patients who have biomarkers (abnormalities in molecules of cells that may or may not help predict cancer) present in their Barrett's esophagus as for patients who do not have biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will have biopsy proven Barrett's esophagus with evidence of specialized intestinal epithelium and dysplasia (either high grade dysplasia or low grade dysplasia) on histology.
- •Patients must have endoscopically visible segments of Barrett's esophagus of greater than 1 centimeter in length.
- •All patients must be eligible for longterm follow-up as well as tolerate endoscopy, biopsy, and cytology.
- •Patients must be willing to travel to Rochester, Minnesota for follow-up
- •Patients must have a friend or relative accompany them on visits since sedatives will render them unable to operate a motor vehicle
- •If patients are on anticoagulation, they must be able to tolerate reversal of anticoagulation for study biopsies and therapy
- •All patients must be able to tolerate proton pump inhibitor therapy. Esomeprazole will be provided but can be changed to another proton pump inhibitor if the patient is intolerant.
- •All patients who have histological or cytological evidence of high grade dysplasia will be seen by an experienced thoracic surgeon for consideration of esophagectomy.
排除标准
- •Patients who are unable to follow light avoidance instructions
- •Patients with a history of prior esophageal surgery or successful fundoplication
- •Patients who had prior photodynamic therapy
- •Patients with pre-existing strictures in their esophagus
- •Patients who have known allergies to porphyrin compounds
- •Patients with a prior biopsies of Barrett's esophagus that contain carcinoma
- •Patients who require continuous anti-coagulation
- •Patients who are pregnant or are capable of pregnancy will be excluded from this study unless they have been on effective birth control measures
- •Lactating mothers are excluded from this study as it is unclear whether the photosensitizer sodium porfimer can cross to the feeding infant
- •Patients with underlying liver disease are excluded since their metabolism of porphyrin based photosensitizers is uncertain. Evidence of liver disease will be an transaminase elevation of three times normal, a bilirubin increase of twice normal, or an alkaline phosphatase (liver fraction) elevation of twice normal.
- •Patients who have underlying medical conditions that are felt to limit their survival to less than one year.
研究组 & 干预措施
radiofrequency ablation of barretts esophagus
Active Comparator
radiofrequency ablation of barretts esophagus
干预措施: radiofrequency ablation of barrett's esophagus (Procedure)
Photodynamic therapy
Active Comparator
will have photodynamic therapy
干预措施: Photodynamic therapy (Procedure)
结局指标
主要结局
The primary assessment for our first specific aim will be to determine the effect of photodynamic therapy on biomarkers after photodynamic therapy.
时间窗: 12 months
次要结局
- The primary assessment for our second specific aim will be to assess if specific biomarkers can be correlated with the confirmed histological elimination of their Barrett's esophagus.(12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Red Light Photobiomodulation and Topical DisinfectantsHealthcare Associated InfectionNosocomial InfectionSurgical Site InfectionNCT05797818Ondine Biomedical Inc.28
招募中
不适用
Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IVPeriodontitis, AdultPeriodontitisNCT06426550Universidade Federal Fluminense20
已完成
1 期
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-upBasal Cell CarcinomaNCT00988455Shahid Beheshti University of Medical Sciences28
Enrolling By Invitation
不适用
Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary MolarsPhotodynamic TherapyNCT05820750Mansoura University60
招募中
不适用
Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of PeriodontitisPeriodontitisNCT06305533University of Baghdad18