Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

NCT01661686 | Completed Results

• 1 other identifier: COPAC
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Esophageal Cancer; Esophageal Stenosis

Keywords

esophageal cancer; esophageal stenosis; stent; endoscopy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrent Dysphagia.

  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.

  From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.

Secondary Outcomes (4)

• Number of Participants With Technical Success of SEMS Placement

  At stent placement (t=0)

• Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score

  From stent placement until death or placement of second stent, assessed up to 6 months.

• Number of Participants in Whom a Major Complication Has Occured

  From stent placement until death or placement of second stent, assessed up to 6 months

• Median Survival After SEMS Placement

  From stent placement until death or placement of second stent

Study Arms (2)

Insertion of a partially covered SEMS

ACTIVE COMPARATOR

Device: Partially covered SEMS

Insertion of a Fully covered SEMS

ACTIVE COMPARATOR

Device: Fully covered SEMS

Interventions

Partially covered SEMS DEVICE

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Also known as: WallFlex Partially covered esophageal stent

Insertion of a partially covered SEMS

Fully covered SEMS DEVICE

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Also known as: WallFlex Fully covered esophageal stent

Insertion of a Fully covered SEMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Liver Research: lead

Study Sites (5)

IJsselland Hospital

Capelle aan den IJssel, South Holland, 2900 AR, Netherlands

Location

Sint Fransiscus Gasthuis

Rotterdam, South Holland, 3045 PM, Netherlands

Location

Ikazia Hospital

Rotterdam, South Holland, 3083 AN, Netherlands

Location

Albert Schweitzer Hospital

Zwijndrecht, South Holland, 3331 LZ, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (1)

• Didden P, Reijm AN, Erler NS, Wolters LMM, Tang TJ, Ter Borg PCJ, Leeuwenburgh I, Bruno MJ, Spaander MCW. Fully vs. partially covered selfexpandable metal stent for palliation of malignant esophageal strictures: a randomized trial (the COPAC study). Endoscopy. 2018 Oct;50(10):961-971. doi: 10.1055/a-0620-8135. Epub 2018 Jun 12.

  PMID: 29895072 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Stenosis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Dr. V.M.C.W. Spaander
• Organization: Erasmus University Medical Center

v.spaander@erasmusmc.nl

0031 10 703 5643

Study Officials

• Marco J Bruno, M.D., Prof

  Erasmus Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 9, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2019-09

Locations

NL (5)