Common Bile Duct Gall StonesPhase 2NCT02545153
Fibrin Sealant for Cholangiotomy Closure Study
A Phase 2 study testing Tisseel, Baxter (Aprotinin and Fibrinogen) in people with Common Bile Duct Gall Stones and Infection, run by Lasarettet i Enköping at 1 site in Sweden.
Trial summary
Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Common Bile Duct Gall Stones, Infection, Bile Leak
- What is being tested?
- Tisseel, Baxter (Aprotinin and Fibrinogen)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Dec 2016
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gallbladder disease
Who cannot join
- Cancer/Tumor
Trial locations and contacts
1 site in 1 country.
Bahman Darkahi Darkahi, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Lasarettet i Enkoping
Enköping, Uppsala County, 754 25
Bahman Darkahi, MD, bahman.darkahi@lul.se
Bahman Darkahi, MD
About this study
Official title: Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
Read the detailed description
Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk of bile leakage from the incision.
A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy.
The present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, Enköping hospital, Sweden. The patients are informed about the study prior to the procedure. Cholangiography is performed routinely. In case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. After the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running Vicryl sutures.
When the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. If the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. A passive drain is introduced before the abdomen is closed.
Postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation.
If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.
All postoperative complications are registered according to the Clavien-Dindo system.
- Conditions
- Common Bile Duct Gall Stones, Infection, Bile Leak
- Being tested
- Tisseel, Baxter (Aprotinin and Fibrinogen), Control
- Medical subject headings
- Gallstones, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisseel, Baxter (Aprotinin and Fibrinogen)Drug
Also called Closing the incision with fibrin sealant
After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.
ControlDrug
Also called Closing the incision without fibrin sealant
No fibrin sealant applied
| Study group | Role | What they receive |
|---|---|---|
| Fibrin sealant | Active comparator | Tisseel, Baxter (Aprotinin and Fibrinogen) Receives: Drug: Tisseel, Baxter (Aprotinin and Fibrinogen) |
| Control | Placebo comparator | Suturing the incision without fibrin glue Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative biliary leakage
The amount of bile in the drain is measured daily until it is withdrawn
Measured: From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJan 2009
- Primary completionJan 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct Gall StonesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lasarettet i Enköping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BAHMAN DARKAHI, Lasarettet i Enköping
- Investigators
- Gabriel Sandblom, Assoc Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545153
- Sponsor's protocol ID
- glue 55 galla
- Status last verified
- Sep 2015
- First submitted
- 10 Oct 2012
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Darkahi B, Norden T, Sandblom G. Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):171-175. doi: 10.1089/lap.2020.0404. Epub 2021 Jun 14.
PubMed 34129409
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
- ClinicalTrials.gov ID
- NCT02545153
- Acronym / sponsor ID
- glue 55 galla
- Conditions
- Common Bile Duct Gall Stones, Infection, Bile Leak
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lasarettet i EnköpingUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Sep 2015 (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.
Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
Detailed description
Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk of bile leakage from the incision.
A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy.
The present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, Enköping hospital, Sweden. The patients are informed about the study prior to the procedure. Cholangiography is performed routinely. In case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. After the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running Vicryl sutures.
When the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. If the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. A passive drain is introduced before the abdomen is closed.
Postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation.
If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.
All postoperative complications are registered according to the Clavien-Dindo system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin sealant | Active comparator | Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)Tisseel, Baxter (Aprotinin and Fibrinogen) |
| Control | Placebo comparator | Drug: ControlSuturing the incision without fibrin glue |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gallbladder disease
Key exclusion criteria (1 listed)
- Cancer/Tumor
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 |
|---|---|---|
| Tisseel, Baxter (Aprotinin and Fibrinogen)Also: Closing the incision with fibrin sealantAfter introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision. | Drug | Fibrin sealant |
| ControlAlso: Closing the incision without fibrin sealantNo fibrin sealant applied | Drug | Control |
Primary outcome
Postoperative biliary leakage
Time frame: From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks
The amount of bile in the drain is measured daily until it is withdrawn
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Derived from this study: PubMed 34129409Darkahi B, Norden T, Sandblom G. Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):171-175. doi: 10.1089/lap.2020.0404. Epub 2021 Jun 14.
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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.
Bahman Darkahi Darkahi, MD contact
Gabriel Sandblom, Assoc Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tisseel, Baxter (Aprotinin and Fibrinogen) in people with Common Bile Duct Gall Stones and Infection, run by Lasarettet i Enköping at 1 site in Sweden.
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 1 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 9 Sep 2015. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Bahman Darkahi Darkahi, MD (bahman.darkahi@lul.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative biliary leakage (time frame: From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks). 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 NCT02545153, which also lists 1 linked publication.
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 9 Sep 2015.