Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial. 2022

Bahman Darkahi, and Torgny Nordén, and Gabriel Sandblom
Department of Surgery, Enköping Hospital, Enköping, Sweden.

There are several methods used to extract common bile duct (CBD) stones encountered during cholecystectomy. Intraoperative cholangiotomy, cholangioscopy, and laparoscopic CBD exploration (LCBDE) are techniques that allow removal of stones from the CBD during the index procedure. However, bile leakage following CBD exploration is a common problem. The aim of this study was to assess whether fibrin sealant applied to the duct incision is safe. Patients planned for laparoscopic gallstone surgery at the Department of Surgery, Enköping Hospital, were included in the study. In cases where perioperative cholangiography showed CBD stones, LCBDE was performed through a longitudinal incision in the CBD. Randomization between closure of the incision with polyglactin sutures or with fibrin sealant was performed. After all the stones had been removed and the incision closed according to the allocation, an abdominal drain was placed close to the incision. A T tube was placed in the CBD or a straight tube into cystic duct for eventual postoperative cholangiogram. The patient and the surgeon assessing the postoperative course were blinded to the randomized allocation. Altogether 51 patients were included from December 2012 to July 2016. Mean operative time was 188 minutes in the fibrin sealant group and 214 minutes in the suture group (P = .159). There was no significant difference between groups in bile flow in the abdominal drainage tube or in the CBD drain during the three first postoperative days. The time to removal of the abdominal drain did not differ significantly between groups. Although the present study lacks the statistical power to prove a benefit from fibrin sealant, it indicates that closure of the incision may be an option to reduce the risk for leakage. Further studies are required to confirm this. The study was retrospectively registered on clinicaltrials.gov September 5, 2015 (NCT02545153).

UI MeSH Term Description Entries
D010535 Laparoscopy A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY. If appropriate, biopsy or surgery can be performed during laparoscopy. Celioscopy,Laparoscopic Surgical Procedures,Peritoneoscopy,Surgical Procedures, Laparoscopic,Laparoscopic Assisted Surgery,Laparoscopic Surgery,Laparoscopic Surgical Procedure,Procedure, Laparoscopic Surgical,Procedures, Laparoscopic Surgical,Surgery, Laparoscopic,Surgical Procedure, Laparoscopic,Celioscopies,Laparoscopic Assisted Surgeries,Laparoscopic Surgeries,Laparoscopies,Peritoneoscopies,Surgeries, Laparoscopic,Surgeries, Laparoscopic Assisted,Surgery, Laparoscopic Assisted
D003135 Common Bile Duct The largest bile duct. It is formed by the junction of the CYSTIC DUCT and the COMMON HEPATIC DUCT. Choledochus,Bile Duct, Common,Common Bile Ducts,Duct, Common Bile
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001646 Bile An emulsifying agent produced in the LIVER and secreted into the DUODENUM. Its composition includes BILE ACIDS AND SALTS; CHOLESTEROL; and ELECTROLYTES. It aids DIGESTION of fats in the duodenum. Biliary Sludge,Sludge, Biliary
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D015718 Fibrin Tissue Adhesive An autologous or commercial tissue adhesive containing FIBRINOGEN and THROMBIN. The commercial product is a two component system from human plasma that contains more than fibrinogen and thrombin. The first component contains highly concentrated fibrinogen, FACTOR VIII, fibronectin, and traces of other plasma proteins. The second component contains thrombin, calcium chloride, and antifibrinolytic agents such as APROTININ. Mixing of the two components promotes BLOOD CLOTTING and the formation and cross-linking of fibrin. The tissue adhesive is used for tissue sealing, HEMOSTASIS, and WOUND HEALING. Autologous Fibrin Tissue Adhesive,Fibrin Adhesive,Fibrin Glue,Fibrin Sealant System,Fibrinogen Adhesive,Beriplast,Crosseal,Fibrin Klebe System Immuno,Fibrin Seal,Fibrin Sealant,Fibrin Sealant, Human,Tisseel,Tissel,Tissucol,Transglutine,Adhesive, Fibrin,Adhesive, Fibrin Tissue,Adhesive, Fibrinogen,Glue, Fibrin,Human Fibrin Sealant,Seal, Fibrin,Sealant System, Fibrin,Sealant, Fibrin,Sealant, Human Fibrin,Tissue Adhesive, Fibrin
D017081 Cholecystectomy, Laparoscopic Excision of the gallbladder through an abdominal incision using a laparoscope. Cholecystectomy, Celioscopic,Laparoscopic Cholecystectomy,Celioscopic Cholecystectomies,Celioscopic Cholecystectomy,Cholecystectomies, Celioscopic,Cholecystectomies, Laparoscopic,Laparoscopic Cholecystectomies
D042882 Gallstones Solid crystalline precipitates in the BILIARY TRACT, usually formed in the GALLBLADDER, resulting in the condition of CHOLELITHIASIS. Gallstones, derived from the BILE, consist mainly of calcium, cholesterol, or bilirubin. Biliary Calculi,Common Bile Duct Gall Stone,Common Bile Duct Gallstone,Gallstone,Biliary Calculi, Common Bile Duct,Common Bile Duct Calculi,Common Bile Duct Gall Stones,Common Bile Duct Gallstones,Gall Stone,Gall Stones,Gall Stones, Common Bile Duct,Gallstones, Common Bile Duct,Calculi, Biliary
D042883 Choledocholithiasis Presence or formation of GALLSTONES in the COMMON BILE DUCT. Cholelithiasis, Common Bile Duct

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