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Efficacy and safety of a novel self-venting biliary spiral stent and nasal biliary duct for temporary biliary drainage after complete endoscopic lithotomy in patients with choledocholithiasis: a multicenter, prospective, non-inferior, randomized controlled study

Efficacy and safety of a novel self-venting biliary spiral stent and nasal biliary duct for temporary biliary drainage after complete endoscopic lithotomy in patients with choledocholithiasis: a multicenter, prospective, non-inferior, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093140
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Choledocholithiasis may cause obstruction of the bile duct, causing right upper abdominal pain, jaundice, fever and other symptoms. Severe choledocholithiasis may also cause complications such as cholangitis and pancreatitis.

Interventions

Nasobiliary duct group (Group B):In the nasobiliary group, temporary biliary drainage was applied after ERCP
Spiral support Group (Group A):In the spiral stent group, biliary spiral stent was used for temporary biliary drainage after ERCP

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Participate voluntarily and sign informed consent; 2.Complete removal of choledocholithiasis by ERCP was intended;

Exclusion criteria

Exclusion criteria: 1.ERCP failed to intubate or lithotomy; 2.ERCP failed to take stone completely; 3.The presence of benign and malignant biliary stenosis requires long-term biliary drainage; 4.Moderate to severe acute cholangitis or acute pancreatitis existed before surgery; 5.Percutaneous transhepatic drainage was performed after the onset of the disease; 6.Gastrointestinal bleeding; 7.Previous history of intestinal obstruction; 8.Pregnant or lactating women; 9.Surgical gastrointestinal reroute;

Design outcomes

Primary

MeasureTime frame
Postoperative cholangitis;Postoperative pancreatitis;

Secondary

MeasureTime frame
Stent-related digestive tract injury;Stent retention;Nasobiliary duct related adverse events;bleeding;perforation;Postoperative hospital stay;Support discharge time;Nasobiliary duct extraction time;medical expenditure;

Countries

China

Contacts

Public ContactHu Bing

West China Hospital of Sichuan University

hubingnj@163.com+86 28 85422522

Outcome results

None listed

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