Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Patient characteristic: age |
Patient age at baseline, so at the day of stent placement, measured in years |
1 day, at stent placement |
|
| Other |
Patient characteristic: gender |
Patient gender at baseline, at the day of stent placement, measured as male or female |
1 day, at stent placement |
|
| Other |
Patient characteristic: tumor location |
Location of the tumor in the esophagus, measured in cm from incisors during stent placement |
1 day, during stent placement |
|
| Other |
Patient characteristic: tumor histology |
Histology of the tumor in the esophagus, measured from biopsy results from upper endoscopies perfomed prior to the stent placement |
1 day, checking PA records |
|
| Other |
Stent characteristic: length of the stent |
Length of the stent, determined during stent placement in millimeters |
1 day, during stent placement |
|
| Other |
Stent characteristic: diameter of the stent |
Diameter of the stent, determined during stent placement in millimeters |
1 day, during stent placement |
|
| Other |
Patient characteristic: prior radiotherapy |
Determining whether patient received radiotherapy prior to the stent placement, described as yes or no |
1 day, before stent placement |
|
| Other |
Patient characteristic: prior chemotherapy |
Determining whether patient received chemotherapy prior to the stent placement, described as yes or no |
1 day, before stent placement |
|
| Primary |
Complication: incidence of perforation |
The complication perforation during stent placement and during follow-up will be measured using patient anamneses and if necessary upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage. |
6 months |
|
| Primary |
Complication: incidence of hemorrhage |
The complication hemorrhage will be measured during stent placement and follow-up using patient anamneses and if necessary with an upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage. |
6 months |
|
| Primary |
Complication: incidence of fistula formation |
The complication fistula formation will be measured during stent placement and during follow-up using patient anamneses and if necessary with an upper endoscopy and is described as present yes or no. After all patients are included, the incidence can be described as percentage. |
6 months |
|
| Primary |
Complication: incidence of gastroesophageal reflux |
The complication gastroesophagel reflux will be measured after stent placement with the use of patient anamneses and will be described as present yes or no. After all patients are included, the incidence can be described as percentage. |
6 months |
|
| Primary |
Complication: incidence of stent migration |
The complication stent migration will be measured using a new upper endoscopy in case there is recurrent dysphagia (measured with the Ogilvie Dysphagia score from 0 = no dysphagia to 4 = inability to swallow food or liquids, so the higher te score, the worse the outcome) and described as present yes or no. After all patients are included, the incidence can be described as percentage. |
6 months |
|
| Primary |
Efficacy: clinical outcome |
The clinical outcome will be measured using the Ogilvie Dysphagia Score to determine whether recurrent dysphagia is present after stent placement during follow-up or until death. The Ogilvie Dysphagia Score is a score ranging from 0 = no dysphagia to 4 = inability to swallow any food or liquids, so the higher te score, the worse the outcome. |
6 months |
|
| Primary |
Efficacy: incidence of patients receiving technical successful stent placement |
Technical successful stent placement will be measured during stent placement whether the stent is in the correct position (covering the whole stenosis) and is described as yes or no. After all patients are included, the incidence can be described as percentage. |
1 day, during stent placement |
|
| Secondary |
Incidence of recurrent dysphagia |
Recurrent dysphagia will be asked from the patient and will be measured with the Ogilvie Dysphagia score (ranging from 0 = no dysphagia to 4 = inability to swallow any food or liquids, so the higher te score, the worse the outcome). After all patients are included, the incidence can be described as percentage. |
6 months |
|
| Secondary |
Pain related to esophageal stent (placement) |
Pain related to esophageal stent (placement) measured daily using a patient diary which scores the Visual Analogue Scale (ranging from 0 = no pain to 10 = the worst pain imaginable, so the higher the score, the worse the outcome) during the first two weeks, after this every 4 weeks a telephone call with the patient will be held to discuss pain using the Visual Analogue Scale as well until death/stent removal, or until a maximum of 6 months follow-up) |
6 months |
|
| Secondary |
Overall survival |
Overall survival measured in days |
6 months |
|
