Esophageal Cancer, Esophageal Stenosis
Conditions
Keywords
esophageal cancer, esophageal stenosis, stent, endoscopy
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
Interventions
DEVICEPartially covered SEMS
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
DEVICEFully covered SEMS
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Sponsors
Foundation for Liver Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrent Dysphagia. | From stent placement (t=0) until death or placement of second stent, assessed up to 6 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Technical Success of SEMS Placement | At stent placement (t=0) | Technical succes was defined as succesful deployment of the stent which bridges the stricture |
| 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. | 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 |
| 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 | 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. |
| Median Survival After SEMS Placement | From stent placement until death or placement of second stent | Survival from stent placement until death or placement of second stent |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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 | 48 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not receive allocated intervention | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Insertion of a Partially Covered SEMS | Insertion of a Fully Covered SEMS | Total |
|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 11.4 | 69.2 years STANDARD_DEVIATION 12.1 | 70.1 years STANDARD_DEVIATION 11.8 |
| Dysphagia score | 2.8 units on a scale STANDARD_DEVIATION 0.8 | 2.8 units on a scale STANDARD_DEVIATION 0.7 | 2.8 units on a scale STANDARD_DEVIATION 0.7 |
| Etiology/histology stricture Adenocarcinoma | 24 Participants | 32 Participants | 56 Participants |
| Etiology/histology stricture Extrinsic compression | 2 Participants | 3 Participants | 5 Participants |
| Etiology/histology stricture Other | 1 Participants | 0 Participants | 1 Participants |
| Etiology/histology stricture Squamous cell carcinoma | 22 Participants | 13 Participants | 35 Participants |
| Length of stricture | 5.4 cm STANDARD_DEVIATION 2.6 | 6.0 cm STANDARD_DEVIATION 2.9 | 5.7 cm STANDARD_DEVIATION 2.8 |
| Length of tumor | 6.8 cm STANDARD_DEVIATION 3.1 | 7.6 cm STANDARD_DEVIATION 3.7 | 7.2 cm STANDARD_DEVIATION 3.5 |
| Location stricture Distal esophagus or cardia | 30 Participants | 27 Participants | 57 Participants |
| Location stricture Mid esophagus | 12 Participants | 13 Participants | 25 Participants |
| Location stricture Proximal esophagus | 7 Participants | 8 Participants | 15 Participants |
| Presence of distant metastasis | 30 participants | 30 participants | 60 participants |
| Previous chemotherapy | 22 participants | 26 participants | 48 participants |
| Previous radiotherapy | 19 participants | 18 participants | 37 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 36 Participants | 34 Participants | 70 Participants |
| WHO | 1.4 units on a scale STANDARD_DEVIATION 0.8 | 1.1 units on a scale STANDARD_DEVIATION 0.8 | 1.3 units on a scale STANDARD_DEVIATION 0.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 49 | 3 / 48 |
| serious Total, serious adverse events | 23 / 49 | 18 / 48 |
Outcome results
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.
Time frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insertion of a Partially Covered SEMS | Number of Participants With Recurrent Dysphagia. | 11 Participants |
| Insertion of a Fully Covered SEMS | Number of Participants With Recurrent Dysphagia. | 9 Participants |
Secondary
Median Survival After SEMS Placement
Survival from stent placement until death or placement of second stent
Time frame: From stent placement until death or placement of second stent
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Insertion of a Partially Covered SEMS | Median Survival After SEMS Placement | 92 days |
| Insertion of a Fully Covered SEMS | Median Survival After SEMS Placement | 61 days |
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.
Time frame: From stent placement until death or placement of second stent, assessed up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insertion of a Partially Covered SEMS | Number of Participants in Whom a Major Complication Has Occured | 23 Participants |
| Insertion of a Fully Covered SEMS | Number of Participants in Whom a Major Complication Has Occured | 18 Participants |
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
Time frame: From stent placement until death or placement of second stent, assessed up to 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insertion of a Partially Covered SEMS | Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score | 43 Participants |
| Insertion of a Fully Covered SEMS | Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score | 40 Participants |
Secondary
Number of Participants With Technical Success of SEMS Placement
Technical succes was defined as succesful deployment of the stent which bridges the stricture
Time frame: At stent placement (t=0)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insertion of a Partially Covered SEMS | Number of Participants With Technical Success of SEMS Placement | 47 Participants |
| Insertion of a Fully Covered SEMS | Number of Participants With Technical Success of SEMS Placement | 48 Participants |