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Development and application of individualized TIPS portal vein puncture 3D Printing guide device

Development and application of individualized TIPS portal vein puncture 3D Printing guide device

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037408
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Portal hypertension

Interventions

Experimental group:3D printing guided TIPS
Control group:Conventional tips

Sponsors

The Third Affiliated Hospital of Naval Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old, understand the study process and agree to participate, sign the relevant informed consent; 2. Hepatic portal hypertensive gastrointestinal bleeding due to cirrhosis diagnosed by imaging and laboratory examination by any cause; 3. Gastroesophageal endoscopy confirmed secondary to esophageal cirrhosis with varicose veins bleeding; 4. Refractory ascites (the diagnostic criteria refer to the 2017 Chinese Society of Liver Disease: Guidelines for the diagnosis and treatment of cirrhosis ascites and related complications); 5. Liver function child-pugh score A or B (score 7); 6. liver function Child B-pugh score B with a large amount of ascites and Child-Pugh score C can be performed liver transplantation surgery, or with indications for liver transplantation acute bleeding or recurrent bleeding, TIPS treatment.

Exclusion criteria

Exclusion criteria: 1. Portal vein thrombosis; 2. Cavernous degeneration of portal vein; 3. Diffuse malignant tumor of liver, portal venous thrombus; 4. Contraindications for TIPS surgery, such as obvious liver damage (TBIL5mg/dL), congestive heart failure or severe valvular cardiac insufficiency, severe pulmonary hypertension, severe renal insufficiency, rapid progression of liver failure; 5. There are severe chronic concomitant diseases, embolus events, mental illness, severe infection, combined syphilis or HIV; 6. Pregnancy, contrast agent allergy or other contraindications of angiography.

Design outcomes

Primary

MeasureTime frame
Times of portal vein puncture;

Secondary

MeasureTime frame
Stent patency rate;

Countries

China

Contacts

Public ContactNaijian Ge

The Third Affiliated Hospital of Naval Military Medical University

gelarge@163.com+86 13917466607

Outcome results

None listed

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