Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures
Recruitment status was Recruiting
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Purpose
The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.
| Condition | Intervention | Phase |
|---|---|---|
|
Cholangiocarcinoma |
Procedure: ERCP plus one biliary stent Procedure: ERCP plus two biliary stents |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial |
- Early complications [ Time Frame: 30 days within treatment ] [ Designated as safety issue: No ]
- 30-day mortality [ Time Frame: 30 days within treatment ] [ Designated as safety issue: No ]
- Late complications [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]
- Median survival [ Time Frame: From stent insertion to the death of the patient ] [ Designated as safety issue: No ]
- Successful drainage [ Time Frame: One month after stent insertion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
patients receiving one stent
|
Procedure: ERCP plus one biliary stent
ERCP ＋ one biliary stent insertion
Other Name: endoscopic retrograde cholangiopancreatography
|
|
Active Comparator: 2
patients receiving two stents
|
Procedure: ERCP plus two biliary stents
ERCP ＋ two biliary stents insertion
Other Name: endoscopic retrograde cholangiopancreatography
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Zhaoshen Li, MD | 86-21-25070552 | li.zhaoshen@hotmail.com |
| Contact: Yu Bai, MD | 86-21-25074725 | baiyu1998@hotmail.com |
| China | |
| Changhai Hospital, Second Military Medical University | Recruiting |
| Shanghai, China, 200433 | |
| Contact: Zhaoshen Li, M.D. 86-21-25070552 li.zhaoshen@hotmail.com | |
| Principal Investigator: Zhaoshen Li, M.D. | |
| Slovakia | |
| Department of Surgery and Transplant Center | Recruiting |
| Astrova, Slovakia | |
| Contact: Rastislav KUNDA, M.D. +421-48-4413000, 4412988 rkunda@hotmail.com | |
| Principal Investigator: Rastislav KUNDA, M.D. | |
| Principal Investigator: | Zhaoshen Li, MD | Changhai Hospital, Second Military Medical University |
More Information
No publications provided
| Responsible Party: | Zhaoshen Li, Changhai Hospital, Second Military Medical University |
| ClinicalTrials.gov Identifier: | NCT00653978 History of Changes |
| Other Study ID Numbers: | Changhai-080129 |
| Study First Received: | April 2, 2008 |
| Last Updated: | June 21, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Changhai Hospital:
|
ERCP cholangiocarcinoma hilar stricture |
Additional relevant MeSH terms:
|
Cholangiocarcinoma Constriction, Pathologic Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013