Recruitment

Recruitment Status
Completed

Inclusion Criteria

Patient is 18 years of age or older
Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.
Patient (or legal representative) is able to understand and provide signed informed consent
Patient is 18 years of age or older
Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.
Patient (or legal representative) is able to understand and provide signed informed consent

Exclusion Criteria

Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
Patient has previously undergone esophageal stenting or esophagectomy
Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
...
Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
Patient has previously undergone esophageal stenting or esophagectomy
Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
Patient is contraindicated for endoscopic procedure for any reason
Removal of stent is scheduled to occur within six months
Patient presents with esophagorespiratory fistula
Patient is unwilling or unable to comply with the follow-up schedule
Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.

Summary

Conditions
Malignant Esophageal Strictures
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Patient is 18 years of age or older
Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.
Patient (or legal representative) is able to understand and provide signed informed consent
Patient is 18 years of age or older
Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.
Patient (or legal representative) is able to understand and provide signed informed consent

Exclusion Criteria

Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
Patient has previously undergone esophageal stenting or esophagectomy
Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
...
Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
Patient has previously undergone esophageal stenting or esophagectomy
Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
Patient is contraindicated for endoscopic procedure for any reason
Removal of stent is scheduled to occur within six months
Patient presents with esophagorespiratory fistula
Patient is unwilling or unable to comply with the follow-up schedule
Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.

Locations

Gainesville, Florida, 32608
Indianapolis, Indiana, 46202
Danville, Pennsylvania, 17822
Milwaukee, Wisconsin, 53226
Rochester, Minnesota, 55905
...
Gainesville, Florida, 32608
Indianapolis, Indiana, 46202
Danville, Pennsylvania, 17822
Milwaukee, Wisconsin, 53226
Rochester, Minnesota, 55905
New York, New York, 10021
Aurora, Colorado, 80045

Tracking Information

NCT #
NCT02159898
Collaborators
  • Geisinger Clinic
  • Medical College of Wisconsin
  • Indiana University
  • University of Colorado, Denver
  • Mayo Clinic
  • Weill Medical College of Cornell University
  • University of Florida
Investigators
  • Principal Investigator: Kulwinder DUA, MD Medical College of WI
  • Kulwinder DUA, MD Medical College of WI