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Comparison of the efficacy of endoscopic ultrasound-guided hepatogastric anastomosis (HGS) alone and endoscopic ultrasound-guided hepatogastric anastomosis combined with anterograde stent placement (HGS+AS) in unresectable distal malignant biliary obstruction with initial ERCP failure: A prospective, multicenter randomized controlled study

Comparison of the efficacy of endoscopic ultrasound-guided hepatogastric anastomosis (HGS) alone and endoscopic ultrasound-guided hepatogastric anastomosis combined with anterograde stent placement (HGS+AS) in unresectable distal malignant biliary obstruction with initial ERCP failure: A prospective, multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105053
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-09-21
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Malignant obstructive jaundice

Interventions

HGS Group:Drainage was performed solely by inserting double pigtail plastic stents between the liver and stomach
HGS+AS group:The plastic stent between the liver and stomach was combined with the anterograde plastic stent placement for drainage

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 18-80 years old; 2. The unresectability of potential malignant tumors (the obstructive site is located at the distal hilum of the liver > 2cm) was determined through MDT consultation. 3. Initial ERCP failure (intestinal stenosis/After digestive tract reconstruction/intubation failure); 4. Histopathological diagnosis of malignant tumors or a 6-month combined follow-up with imaging for the diagnosis of malignant tumors; 5. Jaundice or abnormal liver function; 6 EUS and/or CT and/or MRI revealed intrahepatic bile duct dilation (left side > 3mm); 7. Agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. In patients with coagulation dysfunction (INR>1.3), the peripheral blood microplate count was significantly reduced to <50 × 10^9/L 2. Pregnant women 3. High biliary obstruction 4. Refuse to participate in the study and do not sign the informed consent form;

Design outcomes

Primary

MeasureTime frame
The incidence of stent dysfunction within 6 months;Stent patency time (median);

Secondary

MeasureTime frame
Surgical time;Technical success rate and clinical success rate;Postoperative adverse events;Surgical expenses;Hospitalization expenses;

Countries

China

Contacts

Public ContactHou Senlin

The Second Hospital of Hebei Medical University

housenlin@hebmu.edu.cn+86 158 0321 9882

Outcome results

None listed

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