Skip to content

Clinical Study Protocol for the Safety and Feasibility Evaluation of Covered stent implantation combined with periarterial divestment in the treatment of pancreatic cancer with arterial involvement

Clinical Study Protocol for the Safety and Feasibility Evaluation of Covered stent implantation combined with periarterial divestment in the treatment of pancreatic cancer with arterial involvement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102003
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Pancreatic cancer

Interventions

Covered Stent Implantation Combined with periarterial divestment Group:Covered stent implantation followed by arterial sheath dissection
Periarterial divestment Group:Arterial sheath dissection alone.

Sponsors

The Affiliated BenQ Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1)Preoperative imaging demonstrates involvement of the celiac axis (CA) and its branches — the splenic artery (SA), common hepatic artery (CHA), and left gastric artery (LGA) — with tumor encasement exceeding 180° of the vessel circumference;(2)No evidence of distant metastasis; (3)Undergoing curative-intent pancreatic cancer surgery; (4)Presence of a suitable arterial access route enabling interventional therapy targeting the celiac axis and/or superior mesenteric artery (SMA); (5)Ability to understand the purpose of the study, with voluntary consent to participate; informed consent form signed by the patient or their legally authorized representative, with willingness to adhere to study protocols and complete scheduled follow-ups; (6)Assessment by at least two interventional radiologists confirming the patient as high-risk for surgical intervention, or determination of existing surgical contraindications.

Exclusion criteria

Exclusion criteria: (1)Patients aged >85 years or 400×10?/L), or history of bleeding diathesis/coagulopathy;(11)Pregnancy or lactation;(12)Known allergy to contrast agents;(13)Estimated life expectancy of less than 12 months;(14)Participation in other investigational drug or device clinical trials;(15)Any other condition or abnormality deemed by the investigator to potentially interfere with endovascular intervention.

Design outcomes

Primary

MeasureTime frame
Success rate of covered stent;Arterial rupture rate;Intraoperative blood loss;R0 resection rate of tumor;Postoperative bleeding rate;In hospital mortality;Length of stay;

Secondary

MeasureTime frame
Age;Gender;BMI;blood sugar;Preoperative biliary drainage volume;Pancreatic texture;Pancreatic duct diameter;Pathological classification;Postoperative complications;Hospitalization expenses;Length of hospital stay;Survival prognosis;

Countries

China

Contacts

Public ContactYi Miao

Pancreas Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China

miaoyi@njmu.edu.cn+86 158 0518 9988

Outcome results

None listed

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