Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures

Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653978

Enrollment

150

Registered

2008-04-07

Start date

2008-05-31

Completion date

2011-12-31

Last updated

2011-06-22

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

Conditions

Cholangiocarcinoma

Keywords

ERCP, cholangiocarcinoma, hilar stricture

Brief summary

The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.

Detailed description

Cholangiocarcinoma accounts for 3% of all gastrointestinal cancers and is the second commonest primary liver cancer. However only a few patients are suitable for surgical resection and therefore endoscopic biliary drainage is the most used palliative treatment modality for malignant hilar stricture. However, whether one or two stents can benefit the patients most is still to be defined. Numerous retrospective case series reached different conclusion, till now, only one randomized trial compared the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction, nonetheless, nearly one third of the patients had Bismuth Type I stricture, and one stent is enough for drainage in this situation, therefore, the best drainage strategy for patients with Bismuth Type II or Bismuth Type III malignant hilar obstruction is unknown. The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with Bismuth Type II or III malignant hilar obstruction.

Interventions

PROCEDUREERCP plus one biliary stent

ERCP ＋ one biliary stent insertion

PROCEDUREERCP plus two biliary stents

ERCP ＋ two biliary stents insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Consecutive untreated patients with biliary obstruction (Bismuth type II, III) at the hilum due to primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases. Diagnosis is based on US, CT, and MRCP. * Histologic or cytologic confirmation of malignancy is established by percutaneous biopsy (US- or CT-guided) or by endoscopic tissue sampling, endoscopic brushing. Or the diagnosis is based on typical features on imaging and the expected clinical outcome during follow-up. * All patients were considered unsuitable for resection on the basis of general medical condition and/or tumor extent. * Full and informed consent is obtained.

Exclusion criteria

* Refuse to participate in this study. * Refuse to provide informed consent. * Refuse to be placed with plastic stents. * Physically unfit for endoscopic treatment.

Design outcomes

Primary

Measure	Time frame
Early complications	30 days within treatment

Secondary

Measure	Time frame
30-day mortality	30 days within treatment
Late complications	30 days after treatment
Median survival	From stent insertion to the death of the patient
Successful drainage	One month after stent insertion

Countries

China, Slovakia

Contacts

Primary ContactZhaoshen Li, MD

li.zhaoshen@hotmail.com86-21-25070552

Backup ContactYu Bai, MD

baiyu1998@hotmail.com86-21-25074725

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026