25G and 22G Puncture Needles

Pancreas Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101772
• Other study ID #: HS-2894
• Status: Recruiting
• Start date: September 24, 2021
• Est. completion date: May 24, 2022

Study information

• Verified date: September 2021
• Source: Peking Union Medical College Hospital
• Contact: Yunlu Feng, Doctor
• Phone: 010-69151591
• Email: yunluf[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: May 24, 2022
• Est. primary completion date: April 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Tumor
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The acquisition rate of the core tissue sample	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	The length of the tissue strip	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
Secondary	the technical success rate ?the success rate of immunogrouping dyeing and the retention of the organizational structure	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
Secondary	the incidence of adverse events and the incidence of device defects	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