EUS- and US- Guided Biopsy for Pancreatic Lesion | NCT07138976

Studies
EUS- and US- Guided Biopsy for Pancreatic Lesion

NCT07138976

Sponsor

Tian'an Jiang

Status

Not yet recruiting

Last Update Posted

Aug 24, 2025Actual

Enrollment

2,517Estimated

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

sampling tissue

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2025Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Aug 17, 2025

First Submission Date that Met QC Criteria

Aug 17, 2025

First Posted Date

Aug 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2025

Last Update Posted Date

Aug 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Endoscopic ultrasound (EUS) and ultrasound (US) are the two primary imaging modalities used to guide pancreatic needle biopsy. This study aimed to compare the diagnostic performance and complications associated with EUS- and US-guided pancreatic biopsies.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,517Estimated

Name	Type	Description	Arm Group Labels	Other Names
sampling tissue	Other	EUS- and US- guided pancreatic biopsy

Measure	Description	Time Frame
diagnostic inaccuracy		1-year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between January 2017 and December 2023, 2663 consecutive patients with focal pancreatic disease underwent 2729 procedures for pancreatic tissue acquisition from focal pancreatic lesions at seven university teaching hospitals in China.

Exclusion Criteria:

Patients were excluded from the study if they had less than 12 months of follow-up, were lost to follow-up, had incomplete follow-up data, or underwent intraoperative biopsy or fluid aspiration.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

consecutive patients with focal pancreatic disease underwent procedures for pancreatic tissue acquisition

Sampling Method

Non-Probability Sample

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 17, 2025	Aug 17, 2025	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

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Browse Branches

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