Evaluation of the Efficacy and Safety of a Novel Duodenal Papilla Supporter-assisted Stone Extraction Under Cholangioscopy: A Prospective, Single-Center, Single-Arm Clinical Study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500110424

Enrollment

Unknown

Registered

2025-10-14

Start date

2025-10-15

Completion date

Unknown

Last updated

2025-10-20

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

Conditions

Biliary diseases

Interventions

Novel Duodenal Papilla Supporter Treatment Group:After biliary catheterization, novel duodenal papilla supporter was implanted at the duodenal papilla, avoiding duodenal incision. The aim was to reduc

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Imaging and laboratory examinations confirmed the presence of bile duct stones, with indications for cholangioscopy; 2.Age between 18-80 years; 3. Consent to participation and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications to endoscopic procedures; 2. Evidence of distant or lymph node metastasis on preoperative exam; 3. Declined enrollment or written informed consent; 4. Other situations where the endoscopist deems enrollment unsuitable.

Design outcomes

Primary

Measure	Time frame
Single-session stone removal success rate;	—

Secondary

Measure	Time frame
Postoperative complication (postoperative pancreatitis, cholangitis, bile duct dilation, bile duct gas accumulation, residual stones) incidence rate;Average surgery duration;	—

Countries

China

Contacts

Public ContactLinghu Enqiang

Chinese PLA General Hospital

linghuenqiang@vip.sina.com+86 135 0123 3558

Outcome results

None listed

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