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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insertion of a partially covered SEMS | Active Comparator |
| |
| Insertion of a Fully covered SEMS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially covered SEMS | Device | Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Technical Success of SEMS Placement | Technical succes was defined as succesful deployment of the stent which bridges the stricture | At stent placement (t=0) |
| Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco J Bruno, M.D., Prof | Erasmus Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IJsselland Hospital | Capelle aan den IJssel | South Holland | 2900 AR | Netherlands | ||
| Sint Fransiscus Gasthuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29895072 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insertion of a Partially Covered SEMS | Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available |
| FG001 | Insertion of a Fully Covered SEMS | Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insertion of a Partially Covered SEMS | Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available |
| BG001 | Insertion of a Fully Covered SEMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group. | Posted | Count of Participants | Participants | From stent placement (t=0) until death or placement of second stent, assessed up to 6 months. |
|
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One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insertion of a Partially Covered SEMS | Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe pain | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. V.M.C.W. Spaander | Erasmus University Medical Center | 0031 10 703 5643 | v.spaander@erasmusmc.nl |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D004940 | Esophageal Stenosis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Fully covered SEMS | Device | Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available |
|
|
Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up. 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 |
| 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 | A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula. | From stent placement until death or placement of second stent, assessed up to 6 months |
| Median Survival After SEMS Placement | Survival from stent placement until death or placement of second stent | From stent placement until death or placement of second stent |
| Rotterdam |
| South Holland |
| 3045 PM |
| Netherlands |
| Ikazia Hospital | Rotterdam | South Holland | 3083 AN | Netherlands |
| Albert Schweitzer Hospital | Zwijndrecht | South Holland | 3331 LZ | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015 CE | Netherlands |
Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Dysphagia score | Dysphagia was scored according to the internationally used scoring system: score 0, able to consume a normal diet; score 1, dysphagia with certain solid foods; score 2, able to swallow semi-solid soft foods; score 3, able to swallow liquids only; score 4, complete dysphagia. Range 0-4, a higher score represents a worse outcome | Mean | Standard Deviation | units on a scale |
|
| WHO | World Health Organization Performance Score 0 Able to carry out all normal activity without restrictions.
Range 0-4, a higher score respresents a worse outcome | Mean | Standard Deviation | units on a scale |
|
| Etiology/histology stricture | Count of Participants | Participants |
|
| Presence of distant metastasis | Number | participants |
|
| Previous chemotherapy | Number | participants |
|
| Previous radiotherapy | Number | participants |
|
| Location stricture | Count of Participants | Participants |
|
| Length of tumor | Mean | Standard Deviation | cm |
|
| Length of stricture | Mean | Standard Deviation | cm |
|
| OG001 | Insertion of a Fully Covered SEMS | Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available |
|
|
| Secondary | Number of Participants With Technical Success of SEMS Placement | Technical succes was defined as succesful deployment of the stent which bridges the stricture | Posted | Count of Participants | Participants | At stent placement (t=0) |
|
|
|
| Secondary | Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score | Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up. 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 | Posted | Count of Participants | Participants | From stent placement until death or placement of second stent, assessed up to 6 months. |
|
|
|
| Secondary | Number of Participants in Whom a Major Complication Has Occured | A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula. | Posted | Count of Participants | Participants | From stent placement until death or placement of second stent, assessed up to 6 months |
|
|
|
| Secondary | Median Survival After SEMS Placement | Survival from stent placement until death or placement of second stent | Posted | Median | Full Range | days | From stent placement until death or placement of second stent |
|
|
|
| 23 |
| 49 |
| 4 |
| 49 |
| EG001 | Insertion of a Fully Covered SEMS | Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available | 18 | 48 | 3 | 48 |
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| mediastinitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| stridor | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fistula | Gastrointestinal disorders | Non-systematic Assessment |
|
| spondyloscitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pressure ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mild pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |