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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 8  |  Issue : 3  |  Page : 119-127

Fibrin glue reinforcement of choledochotomy closure suture line for prevention of bile leak in patients undergoing laparoscopic common bile duct exploration and primary closure


1 Department of Surgery, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India
2 Department of Anaesthesia, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India

Date of Web Publication27-Sep-2019

Correspondence Address:
Dr. Bhavna Gupta
98 Om Vihar Phase 1 A, Uttam Nagar, Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ais.ais_1_19

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  Abstract 


Background: Laparoscopic common bile duct (CBD) exploration (LCBDE) allows cholecystectomy and the removal of CBD stones to be performed during the same sitting, thereby decreasing hospital stay. CBD exploration through choledochotomy can be closed primarily with an absorbable suture material but can lead to biliary leakage postoperatively. In this study, we tried to find a solution to further lower the incidence of bile leakage using fibrin glue to reinforce the sutures put on choledochotomy suture line.
Patients and Methods: This study was conducted at a tertiary care teaching hospital in New Delhi, India. Twenty patients with CBD stones documented on magnetic resonance cholangiopancreatography with CBD diameter of 9 mm or more were included in this study. Patients were randomized into two groups, namely – Group “A” in which choledochotomy was closed with polyglactin 4-0 suture and suture line reinforced with fibrin glue and Group “B” in which choledochotomy was closed with polyglactin 4-0 suture alone. Both the groups were evaluated and compared on clinical parameters such as operative time, drain content, drain output, number of days drain was required, blood loss and transfusion requirements, length of postoperative hospital stay, and conversion to open surgery.
Results: The operative time for Group A ranged from 60 to 210 min (mean: 131.50 min) and Group B ranged from 65 to 300 min (mean: 140 min). In Group A, there was no case of bile leak but there was bile leak in 2 cases in Group B, minimum 0 and maximum 900 ml with a mean of 97 ml and P= 0.147 with no statistically significant difference in bile leak in test and control groups. The minimum and maximum serous drainage in Group A was nil and 80 ml (mean: 11 ml) and in Group B was nil and 270 ml (mean: 72.50 ml).P value came as 0.028 which was statistically significant. Thus, serous leakage in Group A was significantly less than in Group B. The drains in Group A were removed from 2 to 4 days (mean: 3 days) while in Group B from 2 to 9 days (mean: 3.9 days). The patients in Group A stayed in hospital postoperatively from 3 to 8 days (mean: 5.30) while in Group B, it ranged from 3 to 10 days with a mean of 5 days.
Conclusion: Fibrin glue application on CBD decreases bile leakage but in statistically insignificant manner. Fibrin glue application on CBD can significantly decrease postoperative serous drainage after LCBDE. Fibrin glue application on CBD is safe and easy technique without any significant adverse effects and can help less experienced surgeons performing LCBDE.

Keywords: Bile leak, fibrin glue, laparoscopic common bile duct exploration, serous leak


How to cite this article:
Gupta A, Chander J, Gupta B, Jain R. Fibrin glue reinforcement of choledochotomy closure suture line for prevention of bile leak in patients undergoing laparoscopic common bile duct exploration and primary closure. Arch Int Surg 2018;8:119-27

How to cite this URL:
Gupta A, Chander J, Gupta B, Jain R. Fibrin glue reinforcement of choledochotomy closure suture line for prevention of bile leak in patients undergoing laparoscopic common bile duct exploration and primary closure. Arch Int Surg [serial online] 2018 [cited 2019 Nov 22];8:119-27. Available from: http://www.archintsurg.org/text.asp?2018/8/3/119/268121




  Introduction Top


Laparoscopic common bile duct (CBD) exploration (LCBDE) allows cholecystectomy and the removal of CBD stones to be performed during the same sitting, thereby decreasing hospital stay. LCBDE can be done through either transcystic or transcholedochal route. Choledochotomy is traditionally closed over T-tube, but it carries significant morbidity, hence not acceptable as a routine practice in the era of minimally invasive surgery. CBD exploration through choledochotomy can be closed primarily with an absorbable suture material but has a risk of biliary leakage postoperatively. In different studies, the incidence of significant bile leak after LCBDE has been found from 0.9% to 1.8%. In this study, we tried a technique to further lower the incidence of bile leakage using fibrin glue to reinforce the sutures put on choledochotomy suture line. Fibrin sealant is made of two components made in separate vials: a freeze-dried concentrate of clotting proteins mainly fibrinogen, factor XIII, and fibronectin (the sealant) and freeze-dried thrombin (the catalyst). It has hemostatic and sealing action, through the strengthening of the last step of the physiological coagulation and biostimulation, which favors the formation of new tissue matrix.


  Patients and Methods Top


Aims and objectives

The aim is to study the efficacy of fibrin glue in reinforcement of choledochotomy closure suture line for prevention of bile leak after LCBDE and primary closure.

This study was conducted at a tertiary care teaching hospital in New Delhi, India. Patients for the study were selected from those presenting to the hospital with the suspicion of choledocholithiasis. All patients with CBD stones with or without jaundice documented on magnetic resonance cholangiopancreatography (MRCP) with CBD diameter of 9 mm or more were included in this study. Patients presenting with cholangitis were managed conservatively with intravenous fluids and antibiotics and were planned for surgery after the resolution of cholangitis. Prophylactic antibiotics (injection ceftriaxone 1 g and injection metronidazole 500 mg) were administered at the time of induction of anesthesia. The duration of operative procedure from skin incision to the application of the last stitch was noted down.

The study included 20 patients who were randomized into two groups using a computer-generated random number [Table 1]: Group “A” in which choledochotomy was closed with polyglactin 4-0 suture and suture line reinforced with fibrin glue and Group “B” in which choledochotomy was closed with polyglactin 4-0 suture alone.
Table 1: Comparison of preoperative, intraoperative, and postoperative parameters

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Surgical procedure

A 10-mm port was inserted at the umbilicus by open technique following which pneumoperitoneum was created. A 10-mm 30° laparoscope was inserted through the umbilical port, and findings were noted. The patient was then placed in the reverse Trendelenburg position of 30° while rotating the table to the left by 15°. This maneuver allows colon and duodenum to fall away from the liver edge. Next, a 12-mm port was placed in the midline in epigastrium under vision. Two accessory 5-mm ports were placed under vision, one in the right anterior axillary line in-between the 12th rib and the iliac crest and the other port was inserted in the right subcostal area in midclavicular line.

With a grasper introduced through the lumbar port, the gallbladder fundus was held and retracted upward and laterally toward the ipsilateral shoulder. The cystic duct was isolated, and a clip was applied so that stones did not migrate from gallbladder into the CBD due to manipulation. The cystic duct was not divided to facilitate retraction. The peritoneum was cleared from anterior surface of CBD above the duodenum. A stay suture was taken at the supraduodenal CBD and choledochotomy made with a fine-needle tip cautery and incision extended with curved scissors after coagulating with harmonic scalpel. The margins of choledochotomy were retracted with an atraumatic forceps or stay sutures, and visible stones were extracted. External milking of the retroduodenal portion and proximal CBD and common hepatic duct was done to retrieve stones in those segments using atraumatic forceps.

Choledochoscopy was done, and biliary tract proximally up to the confluence of the right and left hepatic ducts and distally up to the lower end of CBD was inspected for the presence of calculi and debris by a rigid 10 French (Fr) short ureteroscope (Karl Storz) guided over a 0.025” straight guide wire under continuous pressurized irrigation with normal saline. The ureteroscope was introduced through a 5-mm port placed at the highest point in the epigastrium in the right paramedian position. The remaining calculi if any were removed using Dormia baskets under vision. Impacted calculi were broken using holmium laser. The initial size of the choledochotomy was kept as small as possible, just sufficient to insert the ureteroscope because this will allow better visualization of the CBD due to better distension of the CBD with irrigation fluid. Repeat visualization of the biliary tract was done using the same procedure. The absence of ampullary stenosis and impacted stone at the lower end was ensured by passing the scope over a guide wire into the duodenum, visualization of duodenal mucosa folds, and gradual withdrawal of scope under vision. After that, choledochotomy was closed with 4-0 polyglactin continuous suture over a 10 Fr and 10 cm endobiliary stent. Suctioning of irrigation fluid was done with particular attention to the right and left subphrenic, subhepatic spaces, and pelvis. Following this, cholecystectomy was performed, and a size 28 Fr subhepatic drain was placed in all patients. Subhepatic drain was brought out through the lumbar port site.

After that in Group A patients, choledochotomy closure suture line was reinforced with 1 ml of fibrin glue “Tissel” kit (Baxter) using application cannula [Figure 1] while no such reinforcement was done in Group B.
Figure 1: Laparoscopic glue applicator cannula

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Method of preparation and application of fibrin glue

Tissel kit contains one vial each of:

  1. Sealer protein concentrate (human) in freeze-dried state:


    1. Clottable protein 75–115 mg
    2. Fibrinogen 70–110 mg
    3. Plasma fibronectin 2–9 mg
    4. Factor XIII 10–50 IU
    5. Plasminogen 40–120 μg


  2. Fibrinolysis inhibitor aprotinin solution, (synthetic) liquid 3000 KIU/mL
  3. Thrombin (human) in freeze-dried state 4 IU
  4. Thrombin (human) in freeze-dried state 500 IU
  5. Calcium chloride solution, liquid 40 mmol/L.


All the vials from the Tissel kit were placed into the prewarmed wells of the “Fibrinotherm” machine [Figure 2], using the appropriately sized adapter ring(s), and the vials were allowed to warm for up to 5 min to bring them to a temperature of 37°C. There was a green light and red light in the machine. Green light denoted heating process while in case of overheating, red light lighted up. Freeze-dried sealer protein concentrate and thrombin were reconstituted in fibrinolysis inhibitor solution and calcium chloride solution, respectively. Reconstituted sealer protein concentrate was then stirred in Fibrinotherm machine until all contents were dissolved, and there was no precipitate left, undissolved bubbles disappeared, and the solution was clear. The sealer protein solution and thrombin solution were then combined using the Duploject preparation and application system to form the fibrin sealant. Tissel was applied on the dried surface using a cannula. Amount of Tissel to be used depended on the surface area of application. We used a laparoscopic glue applicator marketed by Baxter for application of prepared glue on choledochotomy closure suture line after primary closure of CBD. One milliliter of glue was found sufficient for appropriate application in CBD. Coagulum formation occurred in about 50 s to 1 min.
Figure 2: Fibrinotherm machine for glue preparation

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Postoperative monitoring

All patients were examined on the evening of the surgery by the operating surgeon for general condition and any early postoperative complications such as bleeding from the port site or hematoma formation or any abnormal drain output as noticed by the color and amount in the drainage bag.

Assessment of bile leakage

Bile leakage score (after 24 h):

No leakage 0

Mild leakage (<50 ml) 1

Moderate leakage (50–100 ml) 2

Heavy/frank bile (>100 ml) 3

Bile leakage index = Bile leakage score × number of days of leakage.

Oral intake was allowed from 12 to 48 h postoperatively in the absence of vomiting and ileus. One gram of injection ceftriaxone 12 hourly and 500 mg of injection metronidazole was given intravenously 8 hourly for 48 h to all the patients. Antibiotics were continued further only if indicated. Injection diclofenac sodium 75 mg was given as per patient's demand, which was documented. From the 2nd day, injection diclofenac sodium was changed to oral diclofenac sodium which was also given as per the patient's demand.

The patients were observed for any complications such as pancreatitis or hyperamylasemia. Serum amylase was done on the 2nd postoperative day. The subhepatic drainage was removed once its drainage had reduced to <30 ml. The patient was ready for discharge after removal of the drain. However, if there were any complications, patients' stay was extended further. Skin staplers or sutures wherever applicable were removed on the 8th postoperative day.

Postoperative follow-up

In all patients, liver function test was done after 4 weeks, and ultrasound hepatobiliary system was done after 2 and 6 weeks of surgery to look for any collection and residual CBD stones. The endobiliary stent was removed by side viewing endoscope at 6 weeks if not passed in alimentary tract on its own.

Clinical parameters evaluated

  1. Operating time (from skin incision to closure of the last skin suture)
  2. Size, number, and position of stones (CBD stones or hepatic duct stones)
  3. Intra- and post-operative complications
  4. Drain content – serous or bilious
  5. Drain output
  6. Number of days, drain was required
  7. Blood loss and transfusion requirements
  8. Incidence of hyperamylasemia and/or pancreatitis
  9. Length of postoperative hospital stay
  10. Conversion to open surgery.



  Results Top


During the period of study, 20 patients of proven choledocholithiasis underwent LCBDE by transcholedochal route. There was no conversion to open, and all patients underwent primary closure of CBD over an endobiliary stent which was removed after 6 weeks. In all, there were 16 females and 4 males; female-to-male ratio was 9:1 in test group while 7:3 in control group, and the two groups were comparable to each other in sex distribution. In Group A, the age of the patients varied from 25 to 72 years with a mean of 43.80 years, whereas in Group B, the age of the patients varied from 30 to 60 years with a mean of 44 years.

Preoperatively, alkaline phosphatase was raised in 8 patients, 4 in each group while it was normal in rest of the patients. The mean duration of symptoms was 10.3 months in fibrin glue group and 7.60 months in control group. Five patients were jaundiced at the time of surgery, 2 in test group and 3 in control group. Preoperative amylase was normal in all patients. There was single stone in CBD in 4 patients and multiple in 6 patients on MRCP in each group. The mean stone size was 12.3 mm in Group A and 11.6 mm in Group B. Thus, groups were comparable with respect to duration of symptoms, stone number, and stone size.

Size of CBD was evaluated preoperatively using MRCP; mean CBD diameter was 14.50 in Group A and 14.25 in Group B. Number of stones removed in patients in Group A ranged from 1 to 6 with a mean of 3.2 stones while it ranged from 1 to 20 stones with a mean of 4.5 stones in Group B. Overall average number of stones extracted per patient was 3.85 stones.

The operative time for patients in Group A ranged from 60 to 210 min with a mean of 131.50 min. The operative time for patients in Group B ranged from 65 to 300 min with a mean of 140 min. The blood loss in patients allocated to Group A ranged from 10 to 120 ml with a mean of 51.50 ml. In Group B, it ranged from 10 to 200 ml with a mean of 53.50 ml. None of our operated patients required intraoperative or postoperative blood transfusion. All the cases had normal postoperative serum amylase levels.

In Group A, there was no case of bile leak but there was bile leak in 2 cases in Group B, minimum 0 and maximum 900 ml with a mean of 97 ml. Data were compared with Mann–Whitney test and P value came 0.147 which means there was no statistically significant difference in bile leak in test and control groups. The bile leak score was calculated according to the scale described below, and all the patients in Group A had bile leakage score of 0 while in Group B, 8 (80%) patients had score of 0, 1 (10%) patient had a score of 2, and 1 (10%) patient had a score of 3. Data were compared with Mann–Whitney test and P value came as 0.329 which means there was no statistically significant difference in bile leak scores in test and control groups. The bile leak index was calculated by multiplying bile leakage score with number of days they drained bile, and all the patients in Group A had bile leakage index of 0 while in Group B, the minimum bile leakage index was 0 and maximum 15 with a mean of 1.70. Data were compared with Mann–Whitney test and P value came 0.147 which means there was no statistically significant difference in bile leak indices in the test and control groups.

The minimum serous drainage in Group A was nil and maximum was 80 ml with a mean of 11 ml. The minimum serous drainage in Group B was nil and maximum was 270 ml with a mean of 72.50 ml [Figure 1]. The data were analyzed using Mann–Whitney test, and the P value came as 0.028 which is statistically significant. Thus, serous leakage in Group A was significantly less than in Group B.

In Group A, the minimum time for the start of oral feeds was 24 h, and the maximum time was 48 h (mean: 37.20). In Group B, the minimum and maximum time were 24 and 84 h, respectively (mean: 39.60). The drains in Group A were removed ranging from 2 to 4 days (mean: 3 days), whereas in Group B, it ranged from 2 to 9 days (mean: 3.9 days). The patients in Group A stayed in hospital postoperatively, ranging from 3 to 8 days (mean: 5.30), whereas in Group B, it ranged from 3 to 10 days with a mean of 5 days.

Except for bile leak in two cases, there was no other postoperative complication like intra-abdominal collection or residual calculi, and this leak subsided conservatively in both cases.


  Discussion Top


Choledocholithiasis is present in 10%–15% of patients with cholelithiasis. Definitive treatment of these patients needs cholecystectomy as well as clearance of the ductal system. Although Langenbuch performed the first cholecystectomy in July 1882, first CBD exploration was performed in January 1890, by Courvoisier. A century later, in the late 1980s, laparoscopic cholecystectomy (LC) was introduced and soon became the standard of care. In the early stages of LC, laparoscopic treatment of CBD stones was neither feasible nor desirable because the surgeons lacked the necessary skills. Thus, patients with suspicion of choledocholithiasis underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP). However, short-term morbidity and mortality after diagnostic and therapeutic ERCP procedures are not negligible. The possibility of long-term complications after endoscopic sphincterotomy also has been addressed. Another treatment option for CBD stones is duct exploration during laparotomy, which has been associated with both high complication rates and insufficient stone clearance.

With increasing skills, laparoscopic surgeons turned their attention to CBD. However, LCBDE can be technically demanding and may include extensive manipulation of bile ducts by instruments. Some surgeons still hesitate to perform LCBDE because of its technical difficulty and potential risks of CBD complications. Following LCBDE, duct can be closed over T-tube, but this procedure carries significant morbidity, and hence, the very purpose of minimal access surgery is defeated as one has to carry T-tube for many weeks. Closure of CBD over biliary stent or primary closure may occasionally be associated with bile leakage, which although uncommon yet a serious complication.

This study was conducted to find if fibrin glue could be of help in decreasing the bile leak after primary closure of CBD over endobiliary stent in LCBDE. Because this study is first of its kind, we preferred to have an endobiliary stent in situ which is passed in alimentary tract on its own or removed endoscopically after 6 weeks. Multiple studies have shown that the use of a biliary endoprosthesis leads to lower morbidity, a shorter hospital stay, less postoperative discomfort, and earlier return to full activities than T-tube placement. Moreover, the presence of the endoprosthesis in the duodenal lumen makes postoperative ERCP easier if there are residual CBD stones. Potential complications after plastic biliary stent placement include bile leak, erosion of adjacent or distant organs, early stent occlusion, and early stent migration. Duodenal erosion, stent occlusion, ampullary stenosis, and distant stent migration leading to intestinal or colonic perforation have also been reported but only in association with long-standing stents (>30 days).[1],[2],[3],[4],[5],[6],[7],[8],[9] In the present study, there were no stent-related complications during the 6-week interval between stent placement and removal. Future studies assessing the role of fibrin glue in LCBDE without using endobiliary stent can be done.

A total of 20 patients were included in the study; 10 patients (Group A) underwent fibrin glue reinforcement of choledochotomy closure suture line after LCBDE, whereas in 10 patients (Group B), CBD was closed only primarily without any fibrin reinforcement.

There were 80% females and 20% males in our study. This sex distribution is similar to that published in literature, the incidence of gall stones being higher in females. Some of these studies are published by Chander et al.[10] (77.33% females and 22.67% males), Schirmer et al.[11] (78% females and 22% males), Southern Surgeons Club [12] (74.9% females and 25.1% males), Cates et al.[13] (70% females and 30% males), and Petelin [14] (74.1% females and 25.9% males).

The age of the patients in our study ranged from 25 to 72 years with a mean of 43.90 years. The mean age in this study is comparatively lower than that reported in literature (mostly western literature) which had reported an older age group like Rhodes et al.[15] (19–94 years, mean: 52 years), Shuchleib et al.[16] (19–86, mean: 55.6 years), Chander et al.[10] (15–72 years, mean: 46.9 years), and Topal et al.[17] (15–86 years, median 65 years), whereas it is comparable with reported series from Schirmer et al.[11] (17–83 years, mean: 43.2 years) and Arvidsson et al.[18] (20–81 years, median 41 years). Comparison may not be appropriate because of small sample size; however, it could be increasing trend of younger patients developing choledocholithiasis.

In our study, 5 patients (25%) of 20 presented with jaundice. This is similar to other published series like Paganini et al.[19] (31.4%) and Rhodes et al.[15] (15.8%). Some studies published higher rate of jaundice than our study like Notash et al.[20] (56.7%) and Cuschieri et al.[21] (58.67%).

The CBD diameter on MRCP in Group A varied from 8 to 19 mm (mean: 14.5 mm) and in Group B, from 9 to 17.4 mm (mean: 14.25). Overall average size of CBD was 14.375 ± 3.34 mm (ranged from 8 to 19 mm) which is comparable to literature like Chander et al.[10] (4.1–30 mm, mean: 13.8 ± 4.7 mm) and Topal et al.[17] (5–30 mm, median 11.5 mm). However, it was higher when compared to Birth et al. (3.8–10 mm, mean: 7.4 mm). Greater average CBD diameter in this study could be because of relatively late presentation of our patients compared to the western counterparts, and moreover, only those with CBD diameter of 9 mm or more were included in this study.

The site, size, and the number of CBD stones removed are not documented adequately in the literature. In this study, 70% patients had stones only in the lower end of CBD and 20% of patients had stones in both supraduodenal and retroduodenal part. Most of the patients had multiple stones ranging from 1 to 20. The average number of stones extracted per patient was 3.85 ± 4.33 which is less than that of Chander et al.[10] (1–70 stones, mean: 7.5 ± 11.8 stones) and greater than that of Isla et al.[22] (1–10 stones median 3.1 stones), Topal et al.[17] (choledochotomy group: 1–24 stones, median 2 stones), and Decker et al.[23] (1–12 stones, median 2 stones). Higher number of stones present in this study coincides with reported numbers published in the study from this institution as well as other Asian countries like Lee et al.[24] (mean of 4.0 in elderly group).

The size of extracted stone in this study varied from 5 to 20 mm (mean: 11.95 ± 3.69 mm). Chander et al.[10] quote average stone size as 11.5 ± 4.8 mm, and this is comparable with our study. The size of largest stone removed was 20 mm which is comparable with that of literature (Rhodes et al.[15] up to 20 mm).

There was no difference in mean operative time in two groups because fibrin glue application is a simple and rapid procedure which hardly takes much time and it takes less than a minute for coagulum to form. The mean operative time in the study was 135.75 ± 61.00 min (range: 60–300 min). This was comparable to studies like Petelin [25] (mean: 154.7 min), Martin et al.[26] (45–300 min, median 130 min), Chander et al.[10] (90–205 min, mean: 139.9 min), Berthou et al.[27] (40–360 min, mean: 137 min) and shorter when compared to Waage et al.[28] (120–420, median 232 min), Robinson et al. (110–360 min, mean: 216 min), Arvidsson et al.[18] (160–310 min, mean: 210 min), Teh et al.[29] (120–240 min, mean: 174 min), and Lee et al.[24] (mean: 188.3 min). However, it was higher when compared with literature like Isla et al.[22] (90–150 min, median 120 min), Rhodes et al.[15] (45–210 min, median 120 min), and Ha et al.[30] (median 120 min).

Fibrin glue has been proved to be helpful in decreasing bile leak from CBD in many animal studies but it was never tried in humans. This was the basis of our hypothesis that fibrin glue could decrease postoperative biliary leakage from CBD also. Fibrin glue was used to reinforce choledochotomy closure suture line in 10 patients. The groups were comparable in terms of age; sex; number, size, and site of stones; presence or absence of jaundice; and the size of CBD. Bile leakage in Group A was nil, and there was bile leak in two cases of Group B, but this difference is not statistically significant which shows that fibrin glue has no additional advantage over primary closure without fibrin glue. This could be due to meticulous closure of choledochotomy as the incidence of bile leakage was uncommon and transient in nature (leakage only in control group and that too mean of 97 ml); however, it may prove useful for less experienced surgeons. This is in contrast to Kram et al.[31] who found fibrin glue effective in healing of biliary anastomosis and reducing bile leak in dogs. Zhang et al.[32] also found fibrin glue effective in healing of choledochojejunostomy, but both these were animal studies, and probably, the results cannot be extrapolated to humans. Furthermore, bile has been shown to have some profibrinolytic activity that might reduce its effectiveness in controlling bile leak. Petzold [33] did not recommend fibrin glue in humans because of risk of stenosis, but during the 2-year period of our study, we did not encounter any case of CBD stricture after fibrin glue application, but long-term follow-up is required.

Similarly, bile leak score was also not statistically significant, being 0 in all cases of Group A and 2 in one case, 3 in another case, and 0 in rest of cases from Group B.

Mean bile leak index was 0 in Group A and 1.70 in Group B. This difference is also not statistically significant because fibrin glue application neither offered additional advantage in bile leakage nor hastened drain removal in a statistically significant manner.

Mean serous drainage in Group A was 11 ml (0–80 ml), whereas in Group B, it was 72.50 ml (0–270 ml). There was a statistically significant reduction in serous drainage after application of fibrin glue on CBD after exploration and primary closure. It can be explained by the sealant effect of fibrin glue on transected lymphatics in the area around CBD during surgical dissection; similar decrease in lymphatic drainage with fibrin glue application has been seen by Ko et al.[34] after axillary dissection in breast cancer patients, but Mortenson et al.[35] reported that there was no benefit in time to drain removal or incidence of seroma formation after inguinal lymph node dissection in melanoma patients.

Oral feeds in this study were allowed after the return of bowel activity by assessing the bowel sounds. Patients in Group A (24–48 h, mean: 37.20 h) and Group B (24–84 h, mean: 39.60 h) are comparable with respect to starting of oral feeds. Very few literatures have mentioned about the start of oral feeds. Teh et al.[29] started their patients orally 24 h after surgery which is comparable with this study.

Mean drain removal time was 3 days in test group versus 3.9 days in the control, but it was not statistically significant. Reducing serous leakage by fibrin glue can hasten the removal of drain in postoperative period.

The benefits of shorter postoperative stay in LCBDE are well documented. The average postoperative hospital stay for Group A patients in our study was 5.30 days (3–8 days), and for Group B, it was 5 days (3–10 days). There was no significant difference in postoperative hospital stay between the two groups in our study. Again, because fibrin glue did not offer any additional advantage over primary closure without fibrin glue, duration of postoperative stay was not affected. Overall average postoperative stay was 5.15 days which is more than that reported by Topal et al.[17] (3 days). However, it was comparable to that reported by Teh et al.[29] (5–12 days, median 4 days), Rhodes et al.[15] (1–18 days, median 4 days), and Ha et al.[30] (mean: 5 days).

The mean blood loss in the fibrin glue group was less than that in the control group, but the difference was not statistically significant. We do not think fibrin glue helped in reducing blood loss from choledochotomy because we used harmonic scalpel to perform choledochotomy, which was very effective in achieving hemostasis.

From our experience of fibrin glue in 10 cases of CBD exploration after data analysis, we found that fibrin glue did not offer additional advantage because as such bile leakage incidence was low due to meticulous closure of choledochotomy, it had a significant effect on serous drainage. There was statistically significant reduction in serous drainage in postoperative period after LCBDE and fibrin glue application. It can be explained by the fact that fibrin glue has a sealant effect on lymphatics in the hepatobiliary region and serous leak that occurs after surgical dissection in the area of CBD is sealed by fibrin glue.


  Conclusion Top


  1. Fibrin glue application on CBD decreases bile leakage but in statistically insignificant manner
  2. Fibrin glue application on CBD can significantly decrease postoperative serous drainage after LCBDE
  3. Fibrin glue application on CBD is safe and easy technique without any significant adverse effects and can help less experienced surgeons performing LCBDE.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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