Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-04-15 @ 9:00 AM
Study NCT ID:
NCT01992068
Status:
TERMINATED
Last Update Posted:
2017-04-06
First Post:
2013-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Prospective Pilot Study of High-resolution Manometry to Assess Radiation-induced Changes in Esophageal Function in Patients With Lung Cancer
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closure due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to prospectively assess the feasibility of high-resolution manometry to identify radiation-induced changes in esophageal motility and contractility or "function" in patients undergoing radiation therapy for the treatment of locally advanced lung cancer.
Detailed Description:
As there is no standard of care to evaluate/visualize the effects of radiation therapy (RT) -induced esophageal injury, this is routinely assessed by patient reported accounts, and the symptoms are then managed supportively (e.g. with pain medicines, parenteral nutrition, feeding tubes etc). Manometry has been frequently used to study the effects of RT on gastrointestinal function in the setting of numerous malignancies, including colorectal, cervical and prostate cancers. What is often seen after RT is decreased sphincter function in the anorectal region leading to problems with continence and fecal urgency, however there has not been as rigorous of an evaluation of esophageal function after RT.
One study performed more than 15 years ago included only 4 patients with lung cancer and concluded that mucosal irritation was likely the primary cause of RT-associated esophageal injury and no abnormalities in motility were seen. Radiation is known to cause long-term esophageal injury including stricture, and there is manometric evidence of impaired motility long-term after RT. The recent introduction of high-resolution manometry permits more extensive evaluation of the effects of RT on esophageal function.
One study performed more than 15 years ago included only 4 patients with lung cancer and concluded that mucosal irritation was likely the primary cause of RT-associated esophageal injury and no abnormalities in motility were seen. Radiation is known to cause long-term esophageal injury including stricture, and there is manometric evidence of impaired motility long-term after RT. The recent introduction of high-resolution manometry permits more extensive evaluation of the effects of RT on esophageal function.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: