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25G and 22G Puncture Needles

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05101772
Enrollment
73
Registered
2021-11-01
Start date
2021-09-24
Completion date
2022-05-24
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Tumor, Submucosal Tumor

Brief summary

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The acquisition rate of the core tissue sampleOne weekA core tissue sample is defined as a sample with an histological structure that is fully used for tissue evaluation of target lesions.

Secondary

MeasureTime frameDescription
The length of the tissue stripOne weekThe quality of tissue samples obtained by puncture is assessed by the pathologist, whether intact tissue structure is preserved, and the length of tissue strips
the technical success rate 、the success rate of immunogrouping dyeing and the retention of the organizational structureOne weekThe 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.
the incidence of adverse events and the incidence of device defectsone weekAdverse 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.

Countries

China

Contacts

Primary ContactYunlu Feng, Doctor
yunluf@icloud.com010-69151591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026