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Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin sealant | Active Comparator | Tisseel, Baxter (Aprotinin and Fibrinogen) |
|
| Control | Placebo Comparator | Suturing the incision without fibrin glue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tisseel, Baxter (Aprotinin and Fibrinogen) | Drug | After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative biliary leakage | The amount of bile in the drain is measured daily until it is withdrawn | From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bahman Darkahi Darkahi, MD | Contact | bahman.darkahi@lul.se |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Sandblom, Assoc Prof | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lasarettet i Enkoping | Recruiting | Enköping | Uppsala County | 754 25 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34129409 | Derived | 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. |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| D007239 | Infections |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D007611 | Aprotinin |
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Control | Drug | No fibrin sealant applied |
|
|
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000209 |
| Acute-Phase Proteins |
| D001779 | Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |