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To evaluate a new technique of drainage of bile ducts when conventional endoscopy fails

A Prospective evaluation of preoperative biliary drainage using Endoscopic ultrasound guided hepato-gastrectomy in distal malignant biliary obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/008957
Enrollment
16
Registered
2017-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Distal biliary obstruction with obstructive jaundice

Interventions

Intervention1: SELF EXPANDING METAL STENTS: ANY COMPANY Intervention2: Partially covered self expandable metal stent: These are stents designed for endo luminal use which can be deployed under EUS gui

Sponsors

Endoscopy Research foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Willing and able to comply with the study procedures and provide written informed consent to participate in the study 2 Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and ampullary cancers 3 Biliary obstructive symptoms or signs 4 Bilirubin level > 2 mg/dl 5 Patients deemed as resectable by pancreatic protocol CT or MRI 6 Surgery intent within 4 weeks

Exclusion criteria

Exclusion criteria: 1 Biliary strictures caused by confirmed benign tumors 2 Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and ampullary cancers. 3 Hilar stricture or obstruction due to any cause. 4 Neoadjuvant chemotherapy for current malignancy 5 Palliative indication due to reasons other than surgical candidate status 6 Previous biliary drainage by ERCP/PTC 7 Patients for whom endoscopic techniques are contraindicated 8 Participation in another investigational trial within 180 days 9 Pregnancy

Design outcomes

Primary

MeasureTime frame
To study the technical & clinical success and immediate complications of preoperative biliary drainage by EUS-HGS in patients with distal malignant biliary obstructionTimepoint: 2, 4, 6, 8 weeks follow up

Secondary

MeasureTime frame
After EUS-HGS in postoperative period (after surgery) to study 1 Length of hospital stay after surgery 2 Biliary obstruction symptoms assessment (Jaundice and prurutis) Timepoint: 4 weeks

Countries

India

Contacts

Public ContactVinay Dhir

Global Hospital, Mumbai

vinaydhir@gmail.com9819920266

Outcome results

None listed

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