Automated Reporting System for Biliopancreatic Endoscopic Ultrasound
NCT07928102, Not yet recruiting, Qilu Hospital of Shandong University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Automated Reporting System for Biliopancreatic Endoscopic Ultrasound | ClinicalTrials.gov |
| NCT number | NCT07928102 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 420 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Qilu Hospital of Shandong University | ClinicalTrials.gov |
| Conditions | Biliopancreatic Diseases | ClinicalTrials.gov |
| Interventions | Automated Reporting System for Biliopancreatic Endoscopic Ultrasound | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Difference in clinical acceptance rates between system-generated and manual preliminary reports | Preliminary reports from the index EUS examination; assessment within 60 days after EUS. | The within-patient paired difference in clinical acceptance rates, calculated as the rate for system-generated preliminary reports minus that for independently written manual preliminary reports. A report is accepted if it requires no significant clinical corrections-corrections to errors or omissions that could affect lesion localization, diagnosis or clinical management. Failed or blank system-generated reports are classified as not accepted. Non-inferiority is established if the lower limit of the two-sided 95% confidence interval is greater than -5 percentage points. | ClinicalTrials.gov |
| Secondary | Completeness of the system-generated preliminary reports | Index EUS examination; report assessment within 60 days. | In the prospective paired validation, completeness is the proportion of applicable, reference-confirmed items correctly documented in each system-generated preliminary report. Items cover actual examination extent, organ findings, lesion descriptions, and sampling records. | ClinicalTrials.gov |
| Secondary | Number of significant clinical report corrections | Index EUS examination; report assessment within 60 days. | In the prospective paired validation, the number of significant clinical corrections required per system-generated preliminary report will be assessed. Reductions and additions relative to the independent manual preliminary report will also be reported. | ClinicalTrials.gov |
| Secondary | Reporting time of the system-generated preliminary report | During the first automated report-generation task for the index EUS examination, within 30 days after EUS. | In the prospective paired validation, time is measured from submission of all required inputs-including preprocedural clinical data, the endosonographer's speech, EUS videos, and EUS procedure records-to availability of the first system-generated preliminary report. Failed generation will be reported separately. | ClinicalTrials.gov |
| Secondary | Reporting time of the manual preliminary report | During the routine reporting session immediately after the index EUS examination, up to 60 days | Description: In the prospective paired validation, time is measured from the endosonographer beginning routine report preparation to submission of the independent manual preliminary report, without AI assistance. | ClinicalTrials.gov |
| Secondary | Difference in final report completion time with versus without AI assistance | During the assigned reporting tasks for each index EUS examination, up to 60 days | In the randomized endosonographer-reporting substudy, the within-case difference in total time to complete a final report is calculated as unassisted time minus assisted time. Total time includes review of source materials, report generation waiting time where applicable, writing, and verification. This outcome will be formally tested only if non-inferiority of the primary outcome is established. | ClinicalTrials.gov |
| Secondary | Quality of final reports in the endosonographer-reporting substudy | Final reports from the assigned reporting tasks for each index EUS examination; assessment within 60 days after EUS. | In the randomized endosonographer-reporting substudy, the proportion of final reports accepted without significant clinical corrections will be assessed separately for reports completed with and without access to the system-generated preliminary report. Completeness and clinically important errors and omissions will also be reported. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 8
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)