CholangiocarcinomaPhase 4NCT00797121
Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma
A Phase 4 study testing Preoperative biliary drainage in people with Cholangiocarcinoma and Drainage, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma, Drainage, Surgery
- What is being tested?
- Preoperative biliary drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- May 2008to May 2013
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients newly diagnosed
- Resectable patients after imaging assessment and evaluation of general condition of the patient
- TB>85μmol/L
- WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
- No serious disease in heart, lung and kidney
- Written informed consent
Who cannot join
- Unresectable patients.
- Patients have received biliary drainage procedure such as PTBD before admission
- Complicated with chronic hepatitis
- Myocardia infarction record within six months
- Women in pregnancy
- Serious disease in heart, lung or kidney
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Dong Chen, MD, 86-20-87755766 ext. 8096, gzbobsums2004@hotmail.com
Lijian Liang
About this study
Official title: Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)
This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.
Read the detailed description
Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.
- Conditions
- Cholangiocarcinoma, Drainage, Surgery
- Being tested
- Preoperative biliary drainage
- Keywords
- Cholangiocarcinoma, Drainage
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative biliary drainageProcedure or surgery
Percutaneous transhepatic biliary drainage(PTBD) is performed under the guidance of ultrasound. The duration may be around four weeks to make the total bilirubin of patients lower than 85μmol/L.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative biliary drainage | Experimental | Not described Receives: Procedure: Preoperative biliary drainage |
| Controlled group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complication
Measured: 30 days after operation
Secondary outcomes (3)
Postoperative mortality
Measured: 30 days after operation
Overall survival, OS
Measured: May, 2013
Disease free survival, DFS
Measured: May, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Lijian Liang, Study chair, Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen UniversityXiaoyu Yin, MD, Principal investigator, Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797121
- Sponsor's protocol ID
- SUMS-5010
- Other IDs
- Cholangiocarcinoma, Surgery, Drainage
- Status last verified
- Nov 2008
- First submitted
- 24 Nov 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9. doi: 10.1097/00000658-200110000-00010.
PubMed 11573044Nimura Y, Kamiya J, Kondo S, Nagino M, Uesaka K, Oda K, Sano T, Yamamoto H, Hayakawa N. Aggressive preoperative management and extended surgery for hilar cholangiocarcinoma: Nagoya experience. J Hepatobiliary Pancreat Surg. 2000;7(2):155-62. doi: 10.1007/s005340050170.
PubMed 10982608
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)
- ClinicalTrials.gov ID
- NCT00797121
- Acronym / sponsor ID
- SUMS-5010
- Conditions
- Cholangiocarcinoma, Drainage, Surgery
- Keywords
- Cholangiocarcinoma, Drainage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 25 Nov 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.
This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.
Detailed description
Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative biliary drainage | Experimental | Procedure: Preoperative biliary drainage |
| Controlled group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients newly diagnosed
- Resectable patients after imaging assessment and evaluation of general condition of the patient
- TB>85μmol/L
- WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
- No serious disease in heart, lung and kidney
Key exclusion criteria (6 listed)
- Unresectable patients.
- Patients have received biliary drainage procedure such as PTBD before admission
- Complicated with chronic hepatitis
- Myocardia infarction record within six months
- Women in pregnancy
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 |
|---|---|---|
| Preoperative biliary drainagePercutaneous transhepatic biliary drainage(PTBD) is performed under the guidance of ultrasound. The duration may be around four weeks to make the total bilirubin of patients lower than 85μmol/L. | Procedure or surgery | Preoperative biliary drainage |
Primary outcome
Incidence of postoperative complication
Time frame: 30 days after operation
3 secondary outcomes
Postoperative mortality
Time frame: 30 days after operation
Overall survival, OS
Time frame: May, 2013
Disease free survival, DFS
Time frame: May, 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2008.
- Background: PubMed 11573044Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9. doi: 10.1097/00000658-200110000-00010.
- Background: PubMed 10982608Nimura Y, Kamiya J, Kondo S, Nagino M, Uesaka K, Oda K, Sano T, Yamamoto H, Hayakawa N. Aggressive preoperative management and extended surgery for hilar cholangiocarcinoma: Nagoya experience. J Hepatobiliary Pancreat Surg. 2000;7(2):155-62. doi: 10.1007/s005340050170.
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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.
Lijian Liang study chair
Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen University
Xiaoyu Yin, MD principal investigator
Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preoperative biliary drainage in people with Cholangiocarcinoma and Drainage, run by Sun Yat-sen University at 1 site in China.
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 6 inclusion and 6 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 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lijian Liang (86-20-87755766 ext. 8096, lianglj@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complication (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797121, which also lists 2 linked publications.
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 25 Nov 2008.