Skip to content

The efficacy and safety of pancreatic cyst drainage stents in the treatment of pancreatic pseudocyst and walled-off necrosis: a prospective, open, single-group, multicenter study

The efficacy and safety of pancreatic cyst drainage stents in the treatment of pancreatic pseudocyst and walled-off necrosis: a prospective, open, single-group, multicenter study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039955
Enrollment
Unknown
Registered
2020-11-15
Start date
2020-11-20
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Pancreatic pseudocyst and walled-off necrosis

Interventions

Stent drainage group:Stent placement and drainage

Sponsors

Shanghai Changhai Hospital /Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients between 18 and 75 years old, regardless of gender; 2. Patients with pancreatic pseudocyst or encapsulated necrosis diagnosed by enhanced CT; 3. Patients with PFC diameter >= 6cm; 4. The subjects who can understand the purpose of the trial voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with poor general condition, who can't tolerate endoscopy or have contraindications of endoscopic drainage, such as patients with acute inflammation and ulcer of upper digestive tract after digestive tract reconstruction, upper digestive tract stenosis and obstruction, and those who can't pass endoscopy; 2. The patients whose cysts are close to the great vessels, especially those with aneurysms, intracapsular hemorrhage, rupture of cysts, varicose veins of cardia and gastric fundus, and suspicious canceration; 3. Patients with coagulation dysfunction or bleeding tendency; 4. For patients with severe lung or heart disease; 5. Patients with allergic history to nitinol; 6. Pregnant and lactating women and subjects who are going to be pregnant in the near future; 7. Subjects who participated in clinical trials of any drug and / or medical device within 3 months before enrollment; 8. The researchers believe that there are any other factors that are not suitable for inclusion or affect the subjects' participation in the study.

Design outcomes

Primary

MeasureTime frame
Drainage success rate;

Secondary

MeasureTime frame
Technical success rate;

Countries

China

Contacts

Public ContactJin Zhendong

Shanghai Changhai Hospital

zhendjin@126.com+86 13901618837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 31, 2026