Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia

Esophageal Cancer Clinical Trial

Official title:

Randomized, Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894763
• Other study ID #: 1063-04
• Status: Completed
• Phase: Phase 1
• First received: June 26, 2013
• Last updated: July 4, 2013
• Start date: September 2003
• Est. completion date: May 2009

Study information

• Verified date: July 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. The purpose of this study is to learn if stents of different diameters are more or less effective for treatment of dysphagia caused by esophageal cancer.

Description:

This prospective, randomized study was conducted at Tenwek Hospital in Bomet, Kenya, and was approved by the hospital's institutional review board (IRB) as well as the Kenya Medical Research Institute's Ethical Review Committee. Participants with dysphagia were recruited and provided signed informed consent prior to endoscopy. During endoscopy and after dilation of an obstructing esophageal tumor sufficient to permit passage of an endoscope, eligible participants were enrolled and randomized to receive either an 18 mm shaft/23 mm flange or 23 mm shaft/28 mm flange partially covered Ultraflex esophageal stent (Boston Scientific, Natick, Massachusets, USA). Stents were either 10 or 12 cm in length, and the endoscopist chose a stent length based on the length of the malignant stricture. One stent was placed in each subject. Follow-up was then obtained at scheduled intervals after stent placement (7 and 28 days, 3 months, then every 3 months), until the participant's death. Earlier follow-up visits were arranged if participants reported any new health concerns.

Block randomization was performed using the sealed envelope technique, with 10 participants in each block; none of the study personnel at Tenwek Hospital had knowledge of the randomization sequence. Allocation was concealed from participants, caregivers, and study personnel until randomization occurred during an endoscopic procedure. After randomization, stent diameters were known to the endoscopy staff and listed in the medical record. All randomized participants correctly received a stent of the allocated diameter, and remained blinded to the stent diameter they received.

At baseline and each follow-up visit body weight was recorded, as well as Karnofsky performance status score, dysphagia score (0=normal, no dysphagia; 1=can swallow most foods; 2=can swallow a soft diet; 3=can swallow fluids only; 4=unable to swallow saliva), current medications, and the presence or absence of 15 symptoms and 9 diagnoses (weakness, fever, vomiting, vomiting blood, melena, weak voice, difficulty breathing, cough, sputum, palpitations, heartburn, chest pain, hiccoughs, recurrent dysphagia, abdominal pain; anemia, gastrointestinal bleeding, esophago-respiratory fistula, arrhythmia, pneumonia, metastases, stent occlusion, stent migration, gastroesophageal reflux disease). In addition, all interval clinic visits, test results, endoscopy reports, and hospitalizations were reviewed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age = 18 years

• dysphagia due to unresectable esophageal cancer

• participant resides within 50 km of Tenwek Hospital

• tumor is = 9 cm in length and > 2 cm distal to the upper esophageal sphincter (UES)

• no esophago-respiratory fistula (ERF) or suspected perforation is present

Exclusion Criteria:

• unable to provide written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Device:
• Self-expandable metal stent
Placement of a self-expandable metal stent in the esophagus

Locations

Country	Name	City	State
Kenya	Tenwek Hospital	Bomet

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Tenwek Hospital, Bomet, Kenya

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of dysphagia	Number of participants with improvement in dysphagia score to <2	1 month following stent placement	No
Primary	Complications	Number of participants who experience stent-related symptoms (including chest pain, recurrent dysphagia, hematemesis, melena, palpitations) or complications (including gastrointestinal hemorrhage, esophago-respiratory fistula, stent migration, stent occlusion) from the time of stent placement until death or 5-year follow-up.	from stent placement to death or 5 years of follow-up, whichever comes first	Yes
Primary	Mortality	Time (in days) from stent placement to death, assessed by Kaplan-Meier analysis	from stent placement to death or 5 years of follow-up, whichever comes first	No
Secondary	Endoscopic re-intervention	Number of participants undergoing repeat endoscopy to diagnose or treat a stent-related problem at any time from stent placement to death or 5 year follow-up.	from stent placement to death or 5 years of follow-up, whichever comes first	No
Secondary	performance status	Karnofsky performance status, assessed by Kaplan Meier analysis, from stent placement to death or 5-year follow-up.	from stent placement to death or 5 years of follow-up, whichever comes first	No