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A prospective, single-group, open trial to evaluate the efficacy and safety of a novel endoscopic ultrasound puncture needle in the treatment of pancreatic pseudocyst and enveloped necrosis

A prospective, single-group, open trial to evaluate the efficacy and safety of a novel endoscopic ultrasound puncture needle in the treatment of pancreatic pseudocyst and enveloped necrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068715
Enrollment
Unknown
Registered
2023-02-28
Start date
2023-02-28
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

pancreatic pseudocyst

Interventions

Test group:New endoscopic needle aspiration and drainage for pancreatic pseudocyst and encapsulated necrosis

Sponsors

The Affiliated Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients are aged between 18 and 75 years old, regardless of gender; 2. Enhanced CT confirmed pancreatic pseudocyst or encapsulated necrosis; 3. PFC diameter =6cm; 4. The subjects can understand the purpose of the experiment, voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with poor general conditions who could not tolerate endoscopic examination or had contraindications of endoscopic drainage, such as acute inflammation and ulcers of the upper digestive tract after digestive tract reconstruction surgery, upper digestive tract stenosis and obstruction, and endoscopic impassability; 2. Patients with cysts near large vessels, especially those with aneurysms, intracapsular bleeding, cyst rupture, varicose veins of the fundus cardia, suspected cancer and splenectomy; 3. Coagulopathy or bleeding tendency; 4. Patients with severe lung or heart disease; 5. Pregnant and lactating women and those planning to become pregnant recently; 6. Participants participated in clinical trials of any drug and/or medical device in the 3 months prior to enrollment; 7. The investigator considers the presence of any other factors that may be inappropriate for inclusion or affect the subject's participation in the study.

Design outcomes

Primary

MeasureTime frame
Security;Efficacy;

Countries

China

Contacts

Public ContactLv Ying

The Affiliated Drum Tower Hospital of Nanjing University Medical School

13770755008@126.com+86 13770755008

Outcome results

None listed

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