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Evaluate the effects of pancreaticobiliary master on pancreaticobiliary scan by endoscopic ultrasonography physicians: A prospective, single-center, self-controlled study

Evaluate the effects of pancreaticobiliary master on pancreaticobiliary scan by endoscopic ultrasonography physicians: A prospective, single-center, self-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068929
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

None listed

Interventions

BP-Master early assisted group:BP-Master aid was used in the first stage and no aid was used in the second stage
BP-Master late assisted group:No aids are used in the first stage, and BP-master is used in the second stage

Sponsors

First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Endoscopist: (1) Proficient in the routine gastroenteroscopy, with the total number of endoscopic diagnosis and treatment more than 10,000 cases, and the working years of endoscopic diagnosis and treatment >=5 years; (2) Familiar with endoscopic ultrasonography, able to independently complete 8-station scanning of biliary and pancreatic endoscopic ultrasonography, and independent endoscopic ultrasonography was performed in >=150 cases. 2. Patient: (1) No gender limit, aged 18 years or above; (2) Be able to read, understand and sign informed consent; (3) Biliary and pancreatic diseases is suspected, and endoscopic ultrasonography is needed to determine the development of the disease; (4) Clinical symptoms and/or radiological and/or laboratory findings suspect the presence of biliary pancreatic disease (5) High-risk patients with pancreatic cancer: gene mutations known to be associated with pancreatic cancer risk (BRCA2, BRCA1, PALB2, ATM, CDKNA/p16); Familial ductal adenocarcinoma of pancreas; Peutz-Jeghers syndrome (STK11); Lynch syndrome (MLH1/MSH2/MSH6, EPCAM, PMS2); Familial adenomatous polyposis (APC), etc.; (6) The investigator believed that the subjects understood the clinical study procedures and were willing and able to complete all study procedures and follow-up visits and cooperate with the study procedures.

Exclusion criteria

Exclusion criteria: 1. Endoscopist: unable to participate in the two stages before and after self-control. 2. Patient: (1) Have participated in other clinical trials, signed informed consent and are in the follow-up period of other clinical trials; (2) Have participated in clinical trials of the drug and are in the washout period of the test drug or the control drug; (3) Absolute contraindications of endoscopic ultrasonography; (4) Drug or alcohol abuse or psychological disorder in the last 5 years; (5) Pregnant or lactating patients; (6) Bleeding risk or thrombocytopenia; (7) Previous history of digestive system surgery; (8) Serious medical diseases; (9) Upper gastrointestinal obstruction; (10) Previous history of allergic reactions to anesthetics; (11) Anatomical abnormalities of the upper digestive tract caused by advanced tumors; (12) The investigator believes that the patient is not suitable for endoscopic ultrasonography; (13) The investigator considers that the patient has a high-risk disease or other special condition that is not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Missed scanning rate of standard station;

Secondary

MeasureTime frame
Miss rate per standard station;Missed scanning rate of anatomical landmarks;Missed scanning rate of per anatomical landmarks;Operation time;

Countries

China

Contacts

Public ContactChen Lei

First Affiliated Hospital of Army Medical University

chenlei1977603@126.com+86 13228683896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026