| Protocol ID | NCT02926040 |
| Registration Date | 2016-10-06 |
| Status | Terminated |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Country | Switzerland |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2016-10-01 |
| Last Patient Out | 2020-02-25 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT02926040
Impact of Irreversible Electroporation on Quality of Life for Patients With Locally Advanced Pancreatic Cancer
| Field |
GLM
glm-5.1 6605ms / 8959 tok |
CLAUDE
claude-sonnet-4-20250514 4715ms / 10261 tok |
OPENAI
gpt-4o 3635ms / 8804 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
inpatient
inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
|
inpatient
inpatient → inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: inpatient — The study involves irreversible electroporation (IRE) procedures which require general anesthesia and are performed as surgical ablation procedures, indicating patients are hospitalized during the intervention.
|
inpatient
outpatient → inpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: inpatient — The intervention, irreversible electroporation, involves a procedure likely requiring hospitalization and general anesthesia administration.
|
OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility |
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study is explicitly designated as an observational study rather than a randomized controlled trial.
|
N/A
feasibility RCT → N/A
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: N/A — This is an observational study that examines the impact of irreversible electroporation on quality of life outcomes, not a randomized controlled trial.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study is observational as indicated by the 'Study Type' and not an RCT.
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial explicitly uses the NanoKnife irreversible electroporation (IRE) device, which is a physical medical hardware used for soft tissue ablation.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study involves irreversible electroporation using the NanoKnife IRE device, which is a physical medical device that delivers electrical pulses for tissue ablation in pancreatic cancer patients.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial involves the use of the NanoKnife IRE device, which is a physical medical device used for irreversible electroporation in pancreatic cancer treatment.
|
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 | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is irreversible electroporation using the NanoKnife device, which is a medical device and procedural technique used for soft tissue ablation.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is irreversible electroporation (IRE), which is a device-based ablation procedure using the NanoKnife IRE device, fitting the device category.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention involves irreversible electroporation, which is considered a device intervention as it uses the NanoKnife IRE device for ablative therapy.
|
OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary outcomes measure changes in health-related quality of life (HRQoL) using health questionnaires, which falls under the QoL category.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All primary outcomes focus on quality of life measures.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |