Biliary AtresiaNCT01063699
Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
A study testing Laparoscopic Kasai operation in people with Biliary Atresia, run by Hannover Medical School at 1 site in Germany.
Trial summary
This study evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary atresia. The study was stopped due to lower survival with native liver 6 months after the laparoscopic operation. Read more about this study
- Who is it for?
- Ages 1 month to 4 months
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Laparoscopic Kasai operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2003to Sep 2007
- Phase
- Interventional
- 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 1 month to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Biliary atresia
Who cannot join
- < 3000 grs. body weight
- Syndromatic form of biliary atresia
- Significant comorbidity i.e. cardiac
- Contraindication to laparoscopy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School Pediatric Surgery Dpmt.
Hanover, Lower Saxony, 30625
About this study
Official title: Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia
This study evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary atresia. The study was stopped due to lower survival with native liver 6 months after the laparoscopic operation. Follow-up after 24 months confirmed superior results after conventional operation.
Read the detailed description
Objective:
A prospective observational study to compare survival with own liver in laparoscopic versus conventional Kasai portoenterostomy in patients with biliary atresia.
Summary Background Data:
Available studies on laparoscopic versus conventional Kasai portoenterostomy focus on short-term results, include limited numbers of patients and have design limitations.
Methods:
A consecutive series of patients underwent laparoscopic Kasai procedure from 2006 to 2007. Conventionally operated control patients consisted of a consecutive series of infants with biliary atresia operated from August 2003 to 2006. All data were ascertained prospectively using the European Biliary Atresia Registry / EBAR registration forms. Primary outcome measure was survival with own liver 6 months after Kasai without being listed for liver transplantation. An interim analysis was planned after data became available for the first 12 patients who underwent laparoscopic Kasai procedure. In case of a significantly different interim outcome the follow-up period should be extended to 24 months until a final decision should be drawn.
- Conditions
- Biliary Atresia
- Being tested
- Laparoscopic Kasai operation
- Keywords
- biliary atresia - laparoscopy - kasai - portoenterostomy
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Kasai operationProcedure or surgery
Also called hepatoportoenterostomy, coelioscopie
the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lap Kasai | Experimental | Patients in this arm had their necessary Kasai procedure in a laparoscopic way. Receives: Procedure: Laparoscopic Kasai operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation
Measured: one year
Secondary outcomes (2)
Jaundice free survival confirmed by serum bilirubin < 20 umol/l
Measured: 6 months
Feasibility of laparoscopic Kasai with regard to conversions and revisions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startAug 2003
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Claus Petersen, Prof., Study director, MHH pediatric surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063699
- Sponsor's protocol ID
- EBAR 9260
- Status last verified
- Dec 2009
- First submitted
- 4 Feb 2010
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
FUJINO M, KASAI K, KOSEKI A. The effects of temperature on actomyosin adenosinetriphosphatase activity and super-precipitation. Jpn J Physiol. 1959 Jun 25;9(2):228-38. doi: 10.2170/jjphysiol.9.228. No abstract available.
PubMed 13672695Okazaki T, Miyano G, Yamataka A, Kobayashi H, Koga H, Lane GJ, Miyano T. Diagnostic laparoscopy-assisted cholangiography in infants with prolonged jaundice. Pediatr Surg Int. 2006 Feb;22(2):140-3. doi: 10.1007/s00383-005-1609-0. Epub 2005 Dec 8.
PubMed 16341535Ure BM, Kuebler JF, Schukfeh N, Engelmann C, Dingemann J, Petersen C. Survival with the native liver after laparoscopic versus conventional kasai portoenterostomy in infants with biliary atresia: a prospective trial. Ann Surg. 2011 Apr;253(4):826-30. doi: 10.1097/SLA.0b013e318211d7d8.
PubMed 21475026
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia
- ClinicalTrials.gov ID
- NCT01063699
- Acronym / sponsor ID
- EBAR 9260
- Conditions
- Biliary Atresia
- Keywords
- biliary atresia - laparoscopy - kasai - portoenterostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Feb 2010 (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 evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary atresia. The study was stopped due to lower survival with native liver 6 months after the laparoscopic operation. Follow-up after 24 months confirmed superior results after conventional operation.
Detailed description
Objective:
A prospective observational study to compare survival with own liver in laparoscopic versus conventional Kasai portoenterostomy in patients with biliary atresia.
Summary Background Data:
Available studies on laparoscopic versus conventional Kasai portoenterostomy focus on short-term results, include limited numbers of patients and have design limitations.
Methods:
A consecutive series of patients underwent laparoscopic Kasai procedure from 2006 to 2007. Conventionally operated control patients consisted of a consecutive series of infants with biliary atresia operated from August 2003 to 2006. All data were ascertained prospectively using the European Biliary Atresia Registry / EBAR registration forms. Primary outcome measure was survival with own liver 6 months after Kasai without being listed for liver transplantation. An interim analysis was planned after data became available for the first 12 patients who underwent laparoscopic Kasai procedure. In case of a significantly different interim outcome the follow-up period should be extended to 24 months until a final decision should be drawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lap Kasai | Experimental | Procedure: Laparoscopic Kasai operationPatients in this arm had their necessary Kasai procedure in a laparoscopic way. |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Biliary atresia
Key exclusion criteria (4 listed)
- < 3000 grs. body weight
- Syndromatic form of biliary atresia
- Significant comorbidity i.e. cardiac
- Contraindication to laparoscopy
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 |
|---|---|---|
| Laparoscopic Kasai operationAlso: hepatoportoenterostomy, coelioscopiethe Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery. | Procedure or surgery | Lap Kasai |
Primary outcome
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation
Time frame: one year
2 secondary outcomes
Jaundice free survival confirmed by serum bilirubin < 20 umol/l
Time frame: 6 months
Feasibility of laparoscopic Kasai with regard to conversions and revisions
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
- Background: PubMed 13672695FUJINO M, KASAI K, KOSEKI A. The effects of temperature on actomyosin adenosinetriphosphatase activity and super-precipitation. Jpn J Physiol. 1959 Jun 25;9(2):228-38. doi: 10.2170/jjphysiol.9.228. No abstract available.
- Background: PubMed 16341535Okazaki T, Miyano G, Yamataka A, Kobayashi H, Koga H, Lane GJ, Miyano T. Diagnostic laparoscopy-assisted cholangiography in infants with prolonged jaundice. Pediatr Surg Int. 2006 Feb;22(2):140-3. doi: 10.1007/s00383-005-1609-0. Epub 2005 Dec 8.
- Derived from this study: PubMed 21475026Ure BM, Kuebler JF, Schukfeh N, Engelmann C, Dingemann J, Petersen C. Survival with the native liver after laparoscopic versus conventional kasai portoenterostomy in infants with biliary atresia: a prospective trial. Ann Surg. 2011 Apr;253(4):826-30. doi: 10.1097/SLA.0b013e318211d7d8.
- department information on biliary atresia treatmentLink provided by the sponsor.
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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.
Claus Petersen, Prof. study director
MHH pediatric surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Kasai operation in people with Biliary Atresia, run by Hannover Medical School at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 5 Feb 2010. 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 Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation (time frame: one year). 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 NCT01063699, which also lists 3 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 5 Feb 2010.