View clinical trials related to Esophageal Dysplasia.
Filter by:This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.
Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. The investigators hypothesize that asymptomatic esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is designed to determine the prevalence of ESD in residents of southwestern Kenya.
ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.
To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.