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The safety and efficacy of the steep pulse therapy device in ablation for unresectable hilar and distal bile duct cancers

The safety and efficacy of the steep pulse therapy device in ablation for unresectable hilar and distal bile duct cancers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126659
Enrollment
Unknown
Registered
2026-06-12
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Inoperable hilar and distal bile duct cancer

Interventions

Experimental group:steep pulse therapy

Sponsors

Beijing Ditan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patient age: 18 - 85 years old, gender not limited; 2. Patients diagnosed with cholangiocarcinoma through histological or cytological examination, and who have undergone surgical or multidisciplinary consultation but are not suitable or refuse to 1undergo radical surgery; 3. Patients whose tumors are indicated by CT, MRCP, EUS, etc. to have locally invaded major blood vessels or distant metastasis, and cannot be surgically removed; 4. Karmofsky physical function score above 60 points; 5. Have ERCP indications; 6. Have signed written informed consent; 7. Preoperative serum total bilirubin level > 34.2 µmol/L;

Exclusion criteria

Exclusion criteria: 1. Combined with other malignant tumors; 2. Severe liver and kidney dysfunction, severe cardiac and pulmonary dysfunction, high bleeding risk, and recent occurrence of cardiovascular and cerebrovascular accidents, etc., patients unsuitable for surgery; 3. Pregnant or lactating women or those planning to get pregnant during the trial; 4. Patients with severe biliary stenosis where the ERCP guide wire cannot pass through the stenosis; 5. Using other treatment methods that may affect the observation, such as radioactive particle or particle stent implantation, P53 injection, oral chemotherapy, interventional therapy, etc. 6. Participated in other studies within 1 month before inclusion in the study; 7. Pregnant or planning to get pregnant during the trial; 8. Alcohol and/or drug abusers or those judged by the doctor to have poor compliance.

Design outcomes

Primary

MeasureTime frame
Technical success rate;Clinical success rate;Incidence of device defects;

Secondary

MeasureTime frame
Complication rate;Incidence of adverse events, incidence of serious adverse events;

Countries

China

Contacts

Public ContactPing Li

Beijing Ditan Hospital, Capital Medical University

endolp@126.com+86 13501111362

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026