Trial record 8 of 545 for:
Open Studies | "Esophageal Diseases"
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures (COPAC)
This study is currently recruiting participants.
Verified April 2013 by Foundation for Liver Research
Sponsor:
Foundation for Liver Research
Information provided by (Responsible Party):
Manon Spaander, Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01661686
First received: August 1, 2012
Last updated: April 18, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up
| Condition | Intervention |
|---|---|
|
Esophageal Cancer Esophageal Stenosis |
Device: Partially covered SEMS Device: Fully covered SEMS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures |
Resource links provided by NLM:
Further study details as provided by Foundation for Liver Research:
Primary Outcome Measures:
- Recurrent dysphagia. [ Time Frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months. ] [ Designated as safety issue: No ]This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.
Secondary Outcome Measures:
- Technical success of SEMS placement [ Time Frame: At stent placement (t=0) ] [ Designated as safety issue: No ]
- Clinical success defined as improvement of dysphagia score [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ] [ Designated as safety issue: No ]dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months
- Major and minor complication rate [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ] [ Designated as safety issue: No ]This will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 and the EOS18, at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months.
- Survival [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 98 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Insertion of a partially covered SEMS |
Device: Partially covered SEMS
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Other Name: WallFlex Partially covered esophageal stent
|
| Active Comparator: Insertion of a Fully covered SEMS |
Device: Fully covered SEMS
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Other Name: WallFlex Fully covered esophageal stent
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Malignant stricture of the esophagus or cardia
- No curative treatment options available
- Dysphagia grade of at least 2 (i.e. swallow semi-solid foods or less)
- Informed consent
- Age ≥ 18 years
Exclusion Criteria:
- Previous treatment with self-expandable metal stent for same condition
- Evidence of tumor within 2 cm of the upper esophageal sphincter.
- Presence of an esophago-tracheal or -bronchial fistula or both.
- Not able to undergo upper endoscopy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661686
Contacts
| Contact: Manon CW Spaander, M.D., PhD | +31107035643 | v.spaander@erasmusmc.nl |
| Contact: Paul Didden, M.D. | +31107040704 ext *3609 | p.didden@erasmusmc.nl |
Locations
| Netherlands | |
| IJsselland Hospital | Recruiting |
| Capelle a/d IJssel, Zuid Holland, Netherlands, 2900 AR | |
| Contact: Tang tjtang@ysl.nl | |
| Principal Investigator: Thjon Tang, MD, PhD | |
| Ikazia Hospital | Recruiting |
| Rotterdam, Zuid Holland, Netherlands, 3083 AN | |
| Contact: Ter Borg pcj.ter.borg@ikazia.nl | |
| Principal Investigator: Pieter CJ ter Borg, MD, PhD | |
| Sint Fransiscus Gasthuis | Recruiting |
| Rotterdam, Zuid Holland, Netherlands, 3045 PM | |
| Contact: Leeuwenburg i.leeuwenburgh@sfg.nl | |
| Principal Investigator: I Leeuwenburg, MD, PhD | |
| Albert Schweitzer Hospital | Recruiting |
| Zwijndrecht, Zuid Holland, Netherlands, 3331 LZ | |
| Contact: Wolters L.M.M.Wolters@asz.nl | |
| Principal Investigator: Leonieke MM Wolters, MD, PhD | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands, 3015 CE | |
| Contact: Manon CW Spaander v.spaander@erasmusmc.nl | |
| Contact: Paul Didden p.didden@erasmusmc.nl | |
| Principal Investigator: Manon CW Spaander, M.D., PhD | |
Sponsors and Collaborators
Foundation for Liver Research
Investigators
| Study Director: | Marco J Bruno, M.D., Prof | Erasmus Medical Center |
More Information
No publications provided
| Responsible Party: | Manon Spaander, M.D., PhD, Foundation for Liver Research |
| ClinicalTrials.gov Identifier: | NCT01661686 History of Changes |
| Other Study ID Numbers: | COPAC |
| Study First Received: | August 1, 2012 |
| Last Updated: | April 18, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Foundation for Liver Research:
|
esophageal cancer esophageal stenosis stent endoscopy |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Esophageal Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Gastrointestinal Diseases |
Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013