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Procedure

Group 2 for Barrett's Esophagus

Phase 4
Waitlist Available
Led By John D Horwhat, MD
Research Sponsored by Walter Reed Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
** You must be eligible for care within the Department of Defense (DEERS eligible) to be enrolled into this protocol **
Per Groups 1,2,3,4 (above)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up these outcomes are measured at each endoscopy, with limits set on the number of procedures that can be done based on group assignment.
Awards & highlights

Study Summary

In this prospective single center study, up to 25 patients with Barrett's esophagus with LGD or no dysplasia (Group 1), 25 patients with HGD/IMCA (Group 2), 25 patients with esophageal carcinoma confined to the esophageal wall (Group 3) and 25 patients with severe esophageal squamous dysplasia (Group 4) will be treated with endoscopic cryotherapy. This study is single arm and no blinding will be utilized. Interim analysis of the data will be reviewed with a DCI statistician after 14 patients in each group have been treated with cryotherapy and if safety and efficacy is documented to that point in time, we will request the ability to extend the enrollment to a maximum allowable amount of 25 patients per group. The proposed study duration is seven years, allowing two years for patient enrollment and 5 years for post treatment follow-up. Study duration per patient will total approximately six years. Patients with Barrett's esophagus with no dysplasia or low grade dysplasia (group 1) will be treated with cryotherapy at six week intervals until Barrett's mucosa is ablated or six treatments are administered. Patients with Barrett's HGD and IMCA or severe esophageal squamous dysplasia (groups 2 and 4) will be treated with cryotherapy at six-week intervals until Barrett's mucosa is ablated or six treatments are administered. More advanced mass lesions are typically more difficult to eradicate with ablative therapies and may progress faster than patients with IMCA, therefore, patients with more advanced cancer (group 3) will be treated every 2 weeks until the lesion is eradicated up to eight treatments. After cryotherapy treatment is complete (i.e. the esophagus has re-epithelialized with normal squamous epithelium for Groups 1, 2, 4 and the tumor is locally controlled/absent in Group 3), patients will be assessed by endoscopy and biopsy every three months for one year, every six months for two years, then annually for two years (flow sheet - appendix 1; study schedule - appendix 2).

Eligible Conditions
  • Barrett's Esophagus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured throughout the protocol during the treatment phase with cryotherapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured throughout the protocol during the treatment phase with cryotherapy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirm the feasibility and safety of endoscopic cryotherapy in patients with Barrett's esophagus with LGD, HGD, intramucosal cancer and in patients with severe squamous dysplasia.
Secondary outcome measures
Assess the incidence of side effects, complications, adverse events and number of treatment sessions needed to reach primary endpoints.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
Diagnosis of severe dysplasia within esophageal squamous mucosa on pathology review. Deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention. CT scan demonstrating no evidence of advanced esophageal cancer (extension into or through the wall or lymph node involvement). EUS with no evidence of metastatic lymph node involvement or extension of carcinoma beyond the mucosa.
Group II: Group 3Experimental Treatment1 Intervention
Diagnosis of esophageal carcinoma (T1smN0 or T2N0 via EUS). Deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney, or liver disease; or refusal of surgical intervention. CT scan demonstrating no evidence of advanced esophageal cancer (extension into or through the wall or lymph node involvement).
Group III: Group 2Experimental Treatment1 Intervention
Diagnosis of Barrett's esophagus and high grade dysplasia or intramucosal carcinoma. Deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney, or liver disease; or refusal of surgical intervention. CT scan demonstrating no evidence of advanced esophageal cancer (extension into or through the wall or lymph node involvement). Endoscopic ultrasound* (EUS) demonstrating no evidence of metastatic lymph node involvement or extension of carcinoma beyond the mucosa (T1).
Group IV: Group 1Experimental Treatment1 Intervention
Specialized intestinal metaplasia (Barrett's esophagus) documented via endoscopic esophageal biopsy, with standard surveillance biopsies (four-quadrant biopsies obtained every 2-cm the entire length of the specialized intestinal metaplasia in the esophagus) performed within the past two years prior to study enrollment. Biopsies show either low grade dysplasia, indeterminate for dysplasia, or no dysplasia.

Find a Location

Who is running the clinical trial?

Walter Reed Army Medical CenterLead Sponsor
69 Previous Clinical Trials
20,839 Total Patients Enrolled
CSA Medical, Inc.Industry Sponsor
19 Previous Clinical Trials
853 Total Patients Enrolled
John D Horwhat, MDPrincipal InvestigatorWalter Reed Army Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025