| Protocol ID | NCT06070376 |
| Registration Date | 2023-10-06 |
| Status | recruiting |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Country | Brazil |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2023-06-26 |
| Last Patient Out | 2026-08-26 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT06070376
Comparative Study Between Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
| Field |
GLM
glm-5.1 5696ms / 8897 tok |
CLAUDE
claude-sonnet-4-20250514 9796ms / 10190 tok |
OPENAI
gpt-4o 3971ms / 8683 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other |
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The esophageal prosthesis placement procedures are performed in an endoscopy service on an outpatient basis, which constitutes an outpatient clinical setting rather than inpatient hospital care.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention is performed in an outpatient setting at the endoscopy service, with no mention of inpatient admission being required.
|
OK |
| feasibility | feasibility RCT |
feasibility RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — With only 34 participants enrolled, this appears to be a small-scale study designed to compare two medical devices rather than a fully powered efficacy trial.
|
feasibility RCT
fully powered RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: feasibility RCT — The study has a small enrollment of 34 and the focus includes procedural outcomes like reinterventions, which indicates it might be assessing feasibility.
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | yes | yes | yes | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This study compares two types of esophageal stents (devices) for treating dysphagia in cancer patients, not palliative care consultation or service delivery itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial tests esophageal prostheses, which is a device intervention, not palliative care as the intervention.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | no | no | – |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |