NCT03443921

Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial

Extracted Fields (from Registry)
Protocol IDNCT03443921
Registration Date2018-02-23
StatusUnknown Status
SponsorThe First Affiliated Hospital with Nanjing Medical University
CountryChina
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2018-03-01
Last Patient Out2021-03-01
Publicationn
Gender %ALL
Mean Age18 Years - 80 Years
LLM Classifications (Side-by-Side)
Field GLM
glm-5.1
7545ms / 9965 tok 		CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
5515ms / 11414 tok 		OPENAI
gpt-4o
Thinking: o3
5219ms / 9799 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 → mixed
shaky reasoning
✗ No consensus Initial: inpatient Requery: mixed — The study compares up-front surgery (requiring inpatient admission) with neoadjuvant chemotherapy (typically delivered in an outpatient setting), and patients in the chemotherapy group may also transition to surgery, encompassing both care settings.
 inpatient inpatient → inpatient → outpatient
shaky reasoning
✗ No consensus Initial: inpatient Requery: inpatient — The study involves major pancreatic surgery (pancreatectomy with artery divestment technique) which requires hospitalization and overnight stay for both the surgical procedure and post-operative recovery period. Thinking: outpatient — Patients receive chemotherapy on specific days (1, 8, 15) every 28 days and undergo surgery with standard post-operative recovery, then return home between visits.
 outpatient outpatient → inpatient → mixed
shaky reasoning
✗ No consensus Initial: outpatient Requery: inpatient — The intervention involves surgical procedures, which typically require hospitalization and inpatient care. Thinking: mixed — Intervention includes inpatient pancreatic surgery requiring hospitalization and outpatient chemotherapy sessions
setting_place hospital hospital hospital OK
feasibility fully powered RCT fully powered RCT fully powered RCT OK
intervention_pharmacologic no no
shaky reasoning
✓ Unanimous Initial: no
 no yes → yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The experimental arm involves nab-paclitaxel (albumin-bound paclitaxel) chemotherapy as part of the neoadjuvant treatment protocol. Thinking: no — The experimental intervention is the Artery Divestment Technique, which is a surgical procedure, not a drug or medication.
 no yes → no → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The experimental intervention is the artery divestment surgery which does not involve any pharmacologic component. Thinking: no — The experimental arm tests an artery-divestment surgical procedure, while the pharmacologic chemotherapy is used only as comparator or routine adjuvant care, not as the experimental intervention.
 OK
intervention_chemo_immuno_radio yes no → yes
shaky reasoning
✓ Unanimous Initial: no Requery: yes — The trial actively tests a neoadjuvant chemotherapy strategy (nab-paclitaxel combined with gemcitabine) as a primary intervention in one of its randomized arms, comparing it directly against up-front surgery.
 yes yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The study actively compares neoadjuvant chemotherapy (nab-paclitaxel and gemcitabine) as one of the tested interventions against upfront surgery.
 yes yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The trial includes an active intervention group utilizing chemotherapy as an adjuvant and neoadjuvant treatment component.
 OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological no no no OK
intervention_complex no no
shaky reasoning
✓ Unanimous Initial: no
 no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — This trial compares two distinct treatment strategies (upfront surgery vs. neoadjuvant chemotherapy first) rather than a single multi-component intervention with interacting elements.
 no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The study involves two separate arms: surgery (with or without post-operative chemotherapy) and chemotherapy alone, without any interaction between components to form a single complex intervention.
 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 trial includes pharmacologic interventions (e.g., chemotherapy with nab-paclitaxel and gemcitabine) and chemo/immuno/radio therapy.
 no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The study involves a surgical procedure (artery divestment technique) which is a device/procedural intervention and chemotherapy (nab-paclitaxel) which is pharmacologic, both fitting established intervention categories.
 no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention includes a surgical procedure, which is a complex intervention, and chemotherapy, which is a chemo intervention.
 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 yes yes yes OK
pharmacologic_sub chemotherapy N/A
shaky reasoning
✓ Unanimous Initial: N/A
 chemotherapy chemotherapy → chemotherapy
shaky reasoning
✓ Unanimous Initial: chemotherapy Requery: chemotherapy — The trial involves nab-paclitaxel combined with gemcitabine, which are cytotoxic chemotherapy agents used for cancer treatment.
 chemotherapy chemotherapy → chemotherapy
shaky reasoning
✓ Unanimous Initial: chemotherapy Requery: chemotherapy — The trial involves adjuvant chemotherapy using gemcitabine, nab-paclitaxel, and possibly cisplatin, which are cytotoxic agents used in the treatment of cancer.
 OK
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