Endoscopy guided drainage of the bile duct for obstructive jaundice

Not yet recruiting

• Conditions: Neoplasms,

• Registration Number: CTRI/2021/10/037018
• Lead Sponsor: SL Raheja Hospital

Brief Summary

EUS guided bile duct drainage (EUS-BD) has been well established as an alternative to ERCP for bile duct drainage. This encompasses EUS-CDS, EUS-HGS EUS – Antegrade stenting and EUS-RV. With evolving expertise in EUS, emerging technological and stent advances, EUS-BD has become a viable first line alternative to ERCP  in expert hands. EUS guided biliary interventions have become much more acceptable in recent times with several randomised controlled trials proving the clinical efficacy, safety and success . What is unknown is the preferred route of drainage- Is trans-papillary drainage safer than trans-luminal route nor do we have data on the stent patency of the trans papillary route vs. trans-luminal route?  Trans papillary drainage is well into its 5th decade with acceptable complication rates, with well-known short and long term results and negligible chances of bile leak. However there is a significant chance of pancreatitis and wire manipulation may be difficult. Trans luminal stenting is safe in expert hands with little chance of pancreatitis, shorter procedure times. The disadvantage being higher chance of bile leak (? exaggerated risk) and the prohibitory cost of the stents.

**Hypothesis:**

We hypothesize that the stent patency via trans-luminal route is better than that via trans-papillary route.

Possible adverse event and its treatment

GI tract damage

Gastric haemorrhage or perforation

Surgical operation may be required.

Stent migration

Abdominal pain and fever accompanied by elevation of inflammation.

Surgical operation may be required.

 Conclusion:

To evaluate safety and long term outcomes of such EUS guided procedures

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-10
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Diagnosis of pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma, ampullary cancers , hilar blocks, other metastatic conditions eg LN mets, Lymphoma) •Biliary obstructive symptoms or signs •Bilirubin level/ alkaline phosphatase level above normal limits •Patients deemed as unresectable by CT / MRI / PET •Patients with failed ERCP or anticipated difficult ERCP.

Exclusion Criteria

Biliary strictures caused by confirmed benign tumours •Neoadjuvant chemotherapy for current malignancy •Palliative indication due to reasons other than surgical candidate status •Previous biliary drainage by ERCP/PTC •Patients for whom endoscopic techniques are contraindicated •Participation in another investigational trial within 180 days •Pregnancy.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of the study is to compare the stent patency in patients undergoing EUS guided antegrade procedure and EUS-guided HGS.	3, 6 months
We hypothesize that the stent patency via trans-luminal route is better than that via trans-papillary route.	3, 6 months

Secondary Outcome Measures

Name	Time	Method
The secondary aim is to compare the short and long term adverse events of the two procedures	3, 6 months

Trial Locations

Locations (1)

SL Raheja Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

SL Raheja Hospital

🇮🇳(Suburban), MAHARASHTRA, India

Dr Rahul Shah

Principal investigator

9820190508

rahulhshah@hotmail.com