25G and 22G Puncture Needles

November 1, 2021 updated by: Peking Union Medical College Hospital

Multicenter, Randomized, Self-matched Design, Positive Control, Non-inferiority Clinical Study of 25G and 22G Puncture Needles in Solid or Submucosal Pancreatic Masses

The screened patients were randomly assigned 25G puncture needles and 22G puncture needles in a 1;1 ratio, based on the computer-generated random order, before receiving an ultrasound endoscope puncture. Each puncture needle puncture lesions 2 needles, the same type of puncture needle tissue samples taken in the same tissue pathology bottle, all tissues after the completion of the necessary cytological smears, are placed in the Formalin solution to send tissue pathology, pathologists do not know the order of distribution of 2 puncture needles to evaluate the tissue results, all pathology results are reported by the hospital pathology center, audit.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects were 18 years of age or older (inclusive) who were clinically diagnosed with solid pancreatic masses or submucosal masses and required endoscopic ultrasound-guided puncture examination. Seventy-three subjects are planned to be enrolled.

Description

Inclusion Criteria:

  • Clinical diagnosis of real pancreatic swelling or submuscular swelling;
  • Patients need to be guided by ultrasound endoscopy under the guidance of puncture to eliminate malignant lesions or clear lesions;
  • Fully communicate before surgery, understand the risks and benefits of endoscopic operation, and sign an informed consent form.

Exclusion Criteria:

  • There are endoscopic operation contraindications, including abnormal blood clotting, or long-term oral anticoagulant antiplatelet drugs, can not guarantee INR < 1.5, or platelets less than 5 x 10 x 9 / L;
  • Pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The acquisition rate of the core tissue sample
Time Frame: One week
A core tissue sample is defined as a sample with an histological structure that is fully used for tissue evaluation of target lesions.
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of the tissue strip
Time Frame: One week
The quality of tissue samples obtained by puncture is assessed by the pathologist, whether intact tissue structure is preserved, and the length of tissue strips
One week
the technical success rate 、the success rate of immunogrouping dyeing and the retention of the organizational structure
Time Frame: One week
The quality of tissue samples obtained by punctures is evaluated by pathologists, technical success means that puncture 2 needles can obtain sufficient tissue samples for analysis to be evaluated by endoscopy.
One week
the incidence of adverse events and the incidence of device defects
Time Frame: one week
Adverse events refer to adverse medical events that occur in the course of research, including punctured complications such as bleeding, abdominal pain, infection, pancreatitis, etc. throughout the study process.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2021

Primary Completion (Anticipated)

April 24, 2022

Study Completion (Anticipated)

May 24, 2022

Study Registration Dates

First Submitted

September 18, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-2894

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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