| Protocol ID | NCT02064803 |
| Registration Date | 2014-02-17 |
| Status | completed |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Country | Brazil |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2013-06-01 |
| Last Patient Out | 2020-07-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 85 Years |
NCT02064803
Randomized Clinical Trial Comparing Gastric Partitioning Plus Gastro-entero Anastomosis Versus Gastro-entero Anastomosis Only in Patients With Unresectable and Obstructive Distal Gastric Cancer.
| Field |
CLAUDE
claude-sonnet-4-20250514 4961ms / 10194 tok |
OPENAI
gpt-4o 3691ms / 8759 tok |
GLM
glm-5.1 9395ms / 8929 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 | inpatient | inpatient | inpatient | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility |
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — This is a fully powered RCT with 52 participants designed to evaluate clinical effectiveness comparing two surgical procedures with primary outcome being gastric obstruction improvement and secondary outcome being overall survival.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The trial has a specific clinical outcome measure (GOOSS) and an enrollment count of 52, which is sufficiently large for clinical effectiveness studies in this context.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The study evaluates clinical effectiveness by comparing changes in the Gastric Outlet Obstruction Score System (GOOSS) and overall survival with an enrollment of 52, which fits the threshold for a fully powered clinical trial.
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | 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
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a surgical procedure study comparing two different operative techniques for gastric outlet obstruction relief, not a palliative care consultation/referral/service delivery intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial involves surgical procedures in palliative care patients but the intervention tested is not palliative care itself, it is a surgical technique.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a surgical procedure (gastric partitioning) performed for palliative symptom relief in cancer patients, rather than palliative care consultation or service delivery itself.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | yes | yes | yes | OK |
| outcome_symptom | yes | yes | yes | OK |
| 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 |