CholangiocarcinomaPhase 3NCT00653978
Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures
A Phase 3 study testing ERCP plus one biliary stent and ERCP plus two biliary stents in people with Cholangiocarcinoma, run by Changhai Hospital at 2 sites in 2 countries.
Trial summary
The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- ERCP plus one biliary stent and ERCP plus two biliary stents
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2008to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refuse to participate in this study.
- Refuse to provide informed consent.
- Refuse to be placed with plastic stents.
- Physically unfit for endoscopic treatment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, 200433
Zhaoshen Li, M.D., 86-21-25070552, li.zhaoshen@hotmail.com
Zhaoshen Li, M.D.
Slovakia1 site, 1 recruiting
- Recruiting
Department of Surgery and Transplant Center
Astrova
Rastislav KUNDA, M.D., +421-48-4413000, 4412988, rkunda@hotmail.com
Rastislav KUNDA, M.D.
About this study
Official title: Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial
The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.
Read the 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- ERCP plus one biliary stent, ERCP plus two biliary stents
- Keywords
- ERCP, cholangiocarcinoma, hilar stricture
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP plus one biliary stentProcedure or surgery
Also called endoscopic retrograde cholangiopancreatography
ERCP ＋ one biliary stent insertion
ERCP plus two biliary stentsProcedure or surgery
Also called endoscopic retrograde cholangiopancreatography
ERCP ＋ two biliary stents insertion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients receiving one stent Receives: Procedure: ERCP plus one biliary stent |
| 2 | Active comparator | patients receiving two stents Receives: Procedure: ERCP plus two biliary stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early complications
Measured: 30 days within treatment
Secondary outcomes (4)
30-day mortality
Measured: 30 days within treatment
Late complications
Measured: 30 days after treatment
Median survival
Measured: From stent insertion to the death of the patient
Successful drainage
Measured: One month after stent insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653978
- Sponsor's protocol ID
- Changhai-080129
- Status last verified
- Jul 2009
- First submitted
- 2 Apr 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00653978
- Acronym / sponsor ID
- Changhai-080129
- Conditions
- Cholangiocarcinoma
- Keywords
- ERCP, cholangiocarcinoma, hilar stricture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: ERCP plus one biliary stentpatients receiving one stent |
| 2 | Active comparator | Procedure: ERCP plus two biliary stentspatients receiving two stents |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Refuse to participate in this study.
- Refuse to provide informed consent.
- Refuse to be placed with plastic stents.
- Physically unfit for endoscopic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP plus one biliary stentAlso: endoscopic retrograde cholangiopancreatographyERCP ＋ one biliary stent insertion | Procedure or surgery | 1 |
| ERCP plus two biliary stentsAlso: endoscopic retrograde cholangiopancreatographyERCP ＋ two biliary stents insertion | Procedure or surgery | 2 |
Primary outcome
Early complications
Time frame: 30 days within treatment
4 secondary outcomes
30-day mortality
Time frame: 30 days within treatment
Late complications
Time frame: 30 days after treatment
Median survival
Time frame: From stent insertion to the death of the patient
Successful drainage
Time frame: One month after stent insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoshen Li, MD principal investigator
Changhai Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ERCP plus one biliary stent and ERCP plus two biliary stents in people with Cholangiocarcinoma, run by Changhai Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, MD (86-21-25070552, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complications (time frame: 30 days within treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.