Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2009-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
NCT01960712
Endoscopic Stenting Across the Papilla Versus the Leak Site to Treat Bile Leak
NCT03103139
An Evaluation of a New Technique Utilizing a Biologic Glue and Tissue Patch to Seal the Cut Edge of the Pancreas Following Removal of the Tail of the Pancreas
NCT00889213
One vs. Two Stents for Gallbladder Disease
NCT07222527
Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent
NCT02353286
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fibrin sealant
Tisseel, Baxter (Aprotinin and Fibrinogen)
Tisseel, Baxter (Aprotinin and Fibrinogen)
After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.
Control
Suturing the incision without fibrin glue
Control
No fibrin sealant applied
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tisseel, Baxter (Aprotinin and Fibrinogen)
After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.
Control
No fibrin sealant applied
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lasarettet i Enköping
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
BAHMAN DARKAHI
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gabriel Sandblom, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lasarettet i Enkoping
Enköping, Uppsala County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
glue 55 galla
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.