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Wallflex versus Egis stent for palliation of malignant dysphagia’


- candidate number15830
- NTR NumberNTR4307
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2013
- Secondary IDs13-455 Ethical committee Utrecht
- Public TitleWallflex versus Egis stent for palliation of malignant dysphagia’
- Scientific TitleWallflex versus Egis stent for palliation of malignant dysphagia’
- ACRONYMWAVE-study
- hypothesisThe hypothesis is that the Egis stent, which is more flexible (i.e. lower axial force) than the Wallflex stent and has a double stepped shoulder design, leads to less complications and less often to recurrent dysphagia compared to the often used fully covered Wallflex stent.
- Healt Condition(s) or Problem(s) studiedMalignancy , Dysphagia
- Inclusion criteria- Dysphagia due to an inoperable malignant obstruction of the esophagus or gastric cardia.
• Dysphagia is defined as: dysphagia score of 2-4, according to Ogilvie
• Inoperable disease is defined as local tumor infiltration into surrounding organs, distant metastases or a poor general health due to serious concomitant disease
- Written informed consent
- Exclusion criteria-Evidence of tumor growth within 2 cm of the upper esophageal sphincter
-Tumor length > 12 cm
-Previous stent placement for the same condition
-Karnofsky performance scale of <40%
-Patients unfit to undergo conscious sedation
-Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-dec-2013
- planned closingdate10-dec-2015
- Target number of participants116
- InterventionsPatients with malignant dysphagia due to an inoperable malignant obstruction of the esophagus or gastric cardia will be randomly assigned to be treated with a FC Wallflex stent (Boston Scientific, Natick, MA, USA) or FC Egis stent (S&G Biotech Inc., Seoul, Korea) and followed-up for a period of six months or until death.
- Primary outcomeComposite clinical end point of recurrent dysphagia and major complications due to stent placement:
- Recurrent dysphagia is defined as a dysphagia score of ≥ 2 (according to Ogilvie) as a result of stent dysfunction after initial improvement of dysphagia to < 2. Stent dysfunction is defined as stent migration, tumor in- or overgrowth or food bolus impaction objectified during upper endoscopy.
- Major complications due to stent placement are defined as complications leading to hospitalization, unintended prolongation of hospitalization, death or repeat endoscopic intervention with a possible or definite association with stent placement as determined by the treating physician
- Secondary outcome• Technical success; defined as ease of deployment and placement of the stent at the required location and verified by fluoroscopy and/or endoscopy.
• Pain score during the first 14-days after stent placement; scored by the patient on a visual analogue scale (VAS).
• Major complications not related to stent placement; defined as complications leading to hospitalization, unintended prolongation of hospitalization, death or repeat endoscopic intervention without a possible or definite association with stent placement as determined by the treating physician.
• Minor complications due to stent placement; defined as minor complications with a possible or definite association with stent placement as determined by the treating physician.
• Minor complications not related to stent placement; defined as minor complications without a possible or definite association with stent placement as determined by the treating physician.
• Quality of life; measured with the EQ5D questionnaire.
- Timepointsbaseline (before stent):
1. patient characteristics
2. Ogilvie score
3. Karnofsky performance score
4. EQ5D questionnaire


2 weeks:
1. VAS score first 14 days after stent placement
2. Ogilvie score
3. EQ5D questionnaire
4. Presence of specific symptoms (pain, regurgitation, or weight loss), complications and use of symptomatic medication (analgetics, anti-emetics, PPI’s)

1 month:
1. VAS score first 14 days after stent placement
2. Ogilvie score
3. EQ5D questionnaire
4. Presence of specific symptoms (pain, regurgitation, or weight loss),
5. Presence of complications
6. Use of symptomatic medication (analgetics, anti-emetics, PPI’s)

2 months:
1. VAS score first 14 days after stent placement
2. Ogilvie score
3. EQ5D questionnaire
4. Presence of specific symptoms (pain, regurgitation, or weight loss),
5. Presence of complications
6. Use of symptomatic medication (analgetics, anti-emetics, PPI’s)

3 months:
1. VAS score first 14 days after stent placement
2. Ogilvie score
3. EQ5D questionnaire
4. Presence of specific symptoms (pain, regurgitation, or weight loss),
5. Presence of complications
6. Use of symptomatic medication (analgetics, anti-emetics, PPI’s)

4 months:
1. VAS score first 14 days after stent placement
2. Ogilvie score
3. EQ5D questionnaire
4. Presence of specific symptoms (pain, regurgitation, or weight loss),
5. Presence of complications
6. Use of symptomatic medication (analgetics, anti-emetics, PPI’s)

5 months:
1. VAS score first 14 days after stent placement
2. Ogilvie score
3. EQ5D questionnaire
4. Presence of specific symptoms (pain, regurgitation, or weight loss),
5. Presence of complications
6. Use of symptomatic medication (analgetics, anti-emetics, PPI’s)

6 months:
1. VAS score first 14 days after stent placement
2. Ogilvie score
3. EQ5D questionnaire
4. Presence of specific symptoms (pain, regurgitation, or weight loss),
5. Presence of complications
6. Use of symptomatic medication (analgetics, anti-emetics, PPI’s)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD W.F.W. Kappelle
- CONTACT for SCIENTIFIC QUERIESMD W.F.W. Kappelle
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
S&G Biotech
- PublicationsN/A
- Brief summaryDysphagia is a frequently encountered problem in patients with a malignancy of or around the esophagus. At presentation, surgery is not possible in >50% of patients. Palliative therapy is the only option then. The main goal of palliative treatment is to provide rapid and persistent relief of dysphagia. For this, endoscopic placement of a self-expandable metal stent (SEMS) is one of the most evidence-based treatment options. Although a large selection of SEMS is currently available, recurrent dysphagia due to stent migration, tumor in- or overgrowth or food bolus impaction remains a problem. The fully covered (FC) Egis stent has been developed to reduce the incidence of recurrent dysphagia as well as the complication rate. We hypothesize that the Egis stent, which is more flexible than the Wallflex stent and has a double stepped shoulder design, leads to less complications and less often to recurrent dysphagia compared to the often used FC Wallflex stent.
- Main changes (audit trail)
- RECORD5-dec-2013 - 2-feb-2014


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