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Randomized Controlled Clinical Trial of Stented versus Stentless Biliary Anastomosis in Living Donor Liver Transplantation

Short title: Biliary anastomosis with stent and without in LDLT

Mina Makram Hendy*1, Abubakr Mohamed Mohie Eldien2, Amr Ahmed Abdelaal3, MotassemMuhamed Ali4 and AmrAbdElhamidAbd Elkader5

1Assistant lecturer of general surgery, Faculty of Medicine, Al-Minya University, Egypt

2Professor in general and Hepatobiliary surgery, Faculty of Medicine, Al-Minya University, Egypt

3Professor in liver transplantation surgery, Faculty of Medicine, Ain shams University, Egypt

4AssistantProfessor in general and Hepatobiliary surgery, Faculty of Medicine, Al- Minya University, Egypt

5AssistantProfessor in general surgery, Faculty of Medicine, Al-Minya University, Egypt

*Corresponding author:Mina Makram Hendy

Assistant lecturer of general surgery, Faculty of Medicine, Al-Minya University, Egypt

Address:Minya-Egypt Mobile phone: +201092242627 E-mail: [email protected]

ABSTRACT

Background:Living donor liver transplantation (LDLT) is a main management method for end-stage liver diseases (ESLD). Bilious reconstructions of living donor grafts have beenperformed either via Roux-en-Y enteric anastomosis or duct to duct anastomosis.

Aim and objectives:The objectives of this work were to determination of the percentage of bilious complications in theintraductal stent tube(IST) group compared to duct-to-duct biliary anastomosis with no IST within the 1st6-mths postliver transplantations (LT) and to compering the complicationpercentage connected to the stent tubes and its removalvia endoscope

Subjects and Methods: Randomized controlled trial (double- blinded) with registration at clinical trial, this study had been conducted on 30 patients. carried out at Liver transplant unit at Air Force Specialized Hospital and Nasser Institute Hospital.

Results: The following-up interval was one year for surviving patients in both groups.

Biliary complications were developed in nine patients as shown in.Two (13.3%) patients in the non-stented group and 3 (20%) cases in the stented group suffered from biliary leakage with no statistically significant difference between both groups. one (6.7%) patient in the non-stented group suffered from biliary stricture with statistically nonsignificant changeamong both groups. 2-cases (13.3%) in the stented group suffered from biliary stricture with cholangitis. One (6.7%) patient in the no stented

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group suffered from leakage with cholangitis nonsignificant changeamong both groups.

Conclusion: Our work suggested that intra-ductal trans-anastomotic biliary stenting in LDLT can result in relatively same incidence of biliary complications to stent-less anastomosis. Long-term observationsmight be required to collect adequate informationabout this treatment method to become more popular.

Keywords: Living donor liver transplantation, stent-less anastomosis, trans- anastomotic biliary stenting,cholangitis.

Introduction

Biliary tract reconstruction throughout liver transplantation (LT) is the ultimatepracticalstage and the keystone of the technique and is frequentlyaccomplishedvia a duct-to-duct anastomosis. Rarely, receiver and giver biliary stump differences or liver disorder-linkedcausescancause a hepatico- jejunostomy. The appropriateachievement of this practicalstage is vital for post- operative outcomes [1,2].

The bilious complicationincidencesubsequent toLTstillelevated, ranged between 10 and 35% of casesamongst clinical series in spite ofangrowing experiencesall over the world [2, 3, 4].

These complications, mostlycharacterized by biliousleakages and strictures, are accountable for considerable post-transplantations morbidities and graft losing.

Biliary leakshappenfrequentlyin 3-mths post-operatively. This primarycomplicationsranges a 10% to 20 %rates of incidence [3, 4].

Biliary strictures mostlyhappenlately, in 5-to 8-mths and up toa yearas maximum. The informed incidences of biliary strictures still ranging between 5-30 % betweenextensive and latest clinical trials [2, 4].

The usage of an exterior T-tube to decreasebilious complications wasdiscussed for many years [5]. The primarymotivation was to simplifybilious healing and preservesimple accessing to the bilious tract to execute a cholangiography until elimination of the T-tube in consultations, generallyin 6-wks post-transplantations [6].

Thank Manygroupsdon’tutilize an exterior biliary draining in LT any longer.

Furthermore, the efficiency and security of endoscopy biliary stenting wasunderlinedin manyresearches in bilious stenosistreatments [7].

Intraductal stent tube (IST) settlementtailed by its endoscopicallyelimination in the 4- to6-mths post-operatively was to avoid the bilious complications while avoidthe side effects connected to an exterior T-tube usage [8].

Subject and Methods

Randomized controlled trial (double- blinded) with registration at clinical trial, this study had been conducted on 30 patients carried out at Liver transplant unit at Air Force Specialized Hospital and Nasser Institute Hospital.

30-caces were involved in this work from May 2017 to December 2017 who fulfilled inclusion criteria for liver transplant and the follow-up period was one year.

Caseshave been allocated into 2 equal groups: Group-A: 15-cases with internal stent.

Group-B: 15-cases with stentless technique.

Inclusion criteria:Adult cases adequate for a liver transplantation and cases' written informed agreement was gotten.

Exclusion criteria: The patients excluded from the study were with:

History of biliary reconstructions which needs a hepaticojejunostomy for anatomic/biliary diseasescause, any left lobe grafts, any history of biliary surgical

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interventions, any history of TARE or TACE, any patients with intraoperative vascular events were excluded from this study as arterial thrombosis, dissection, and postoperative portal vein thrombosis (PVT) and pediatric patients less than 18 years.

Methods:

All patients involved in the researchhave been exposed to the following:

Patients’ information’s had been collected from the hospital data and connection with them had been through phone calling and hospital follow up visits. Patients had been subjected to clinical and radiological examination.

The included patients are subjected to: -

Detailed history taking, clinical examinations and full lab and radiological investigation including:

Personal data: Name, age, sex, occupation, address, designed sheet has beenused for eachcase to record his information, history of preceding intervention, hospital diagnosis, date of admission in hospital, medical & Past-history, hemodynamics (HR

& NIBP), respiratory profile (RR & SpO2), history of blood disease or diabetes and careful clinical examination in form of general and local examination: Blood pressure, pulse, cardiovascular, neurological, chest assessment and local abdominal examination.

Intraoperative:

The donor operation started with cholecystectomy and cannulation of the cystic duct followed by cholangiography to identify the anatomy of biliary system of the donor.

The hilum was explored gently to identify the site of confluence of the left and right hepatic ducts. we avoid injury to the hepatic ducts by diathermy and to the right hepatic artery, which might cross in front of the common hepatic duct. Clamping of the right hepatic duct by atraumatic clamp to identify site of resection of right duct(s).closure of this stump is done by interrupted figure of eight 6-0 PDS suture.

Completion cholangiogram to be done to insure patency of left duct without stricture or leakage(fig.1). On the other hand, at the recipient, we carefully dissect the pedicle without affection of blood supply of the duct. Anastomoses were done using interrupted 6-0 sutures (with or without stent). We used ERCP beveled stent.

Inpatient Management

Patient underwent LDLT, transferred immediately postoperative to the ICU for 4-10 days as clinically and laboratory indicated. After that they were transferred to the liver transplant ward. Clinical rounds by the physician staff were conducted twice a day or as needed while the patient is hospitalized. Routine care for drains, wound, CVP is performed on complete aseptic technique. Laboratory work up including; full blood count, full clotting profile, assessment of liver and renal function (ALS, AST, Entire Bilirubin, Straight Bilirubin, Alkaline phosphatase, Albumin, Serum Creatinine, BUN, Sodium, Potassium) was repeated daily in the first week, then every other day till discharge.

Re-admission: Patient who will need re-admission due to complications (stricture, leakage, and cholangitis) will be admitted in the same unit.

The postoperative follow-Up Visits after discharge and Outcome Measures: the total number of cases have beenregularly followed-up twice per week if needed during the 1st three months of discharge or if clinically indicated then according to the schedule and the patient condition then once per month. Clinical examination and laboratory investigations in the form of full blood count, full clotting profile,

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assessment of liver and renal function (ALS, AST, Straight Bilirubin,Entire Bilirubin, Albumin, Serum Creatinine,Alkaline phosphatase, BUN, Sodium, Potassium, and Fasting Blood Sugar). Biograph level every visit. Estimation of α-fetoprotein was done monthly in cases of HCC. Radiological following-up is done every day by US in the 1st week then every other day from the second week then weekly during first month of discharge. Abdominal US, Aspiration, CT, MRCP and ERCP were done for suspected biliary leak while MRCP, PTC And ERCP for suspected stricture.US is highly sensitive in early detection of biliary complications as intrahepatic biliary radical dilatation (IHBRD) or any undrained collection. US is also used for draining this collection if clinically indicated. For the group with internal stent, post-operative follow up was done by abdominal X-ray monthly in the first three month to confirm that the stent was in place, and the stent is removed by the 4th month(fig.2).

Ethical consideration: Informed agreement has been attained from all contributors thereafter being knowledgeable about the objectives and procedure of the work as well as applicable objectives. The study processes were free from any dangerous influences on the contributors in addition to the service providers.

Data management and Statistical Analysis: Data entry, processing and statistical analyzing was carried out via SPSS version 20 (Statistical Package for the Social Sciences). Tests of significance (Kruskal-Wallis, Chi square,Wilcoxon’s, logistic regression analysis, and Spearman’s association) have been utilized. Data have been introduced and appropriate analysis was performedin accordance to the sort of data (parametric and nonparametric) acquired for every variable. P-values<0.05 (5%) was considered significant.

Results

Thirty patients were considered for LDLT have been involved in this work according to the inclusion criteria. Cases have been allocated into 2 equal groups one with internal stent and another with stent-less technique. Patient demographic and indication for LDLT are presented in Table 1and 2. Non-significant changes have been found among the studied groups in regard to the ages mean at time of operation and gender. A significant changes were found among the study groups in regard to MELD score. There were no statistically significant differences between the two groups regarding hepatopathy. Males to females proportion was 2.75 and 1.5 in non- stented and stented group, respectively.

The following-up interval was one year for surviving patients in both groups. Biliary complications were developed in nine patients as shown in Table 3. Two (13.3%) cases in the non-stented group and 3 (20%) cases in the stented group suffered from biliary leakage with no statistically significant difference between both groups. 1- cases (6.7%) in the non-stented group suffered from biliary stricture with a nonsignificant change among both groups. 2 (13.3%) cases in the stented group suffered from biliary stricture with cholangitis. One (6.7%) patient in the nonstented group suffered from leakage with cholangitis nonsignificant change among studied groups.

Postoperative vascular complication occurred in one case only in stented group suffered from bleeding. The event remains statistically insignificant as shown in Table 4.

Regarding biliary leakage, the mean duration till occurrence of leakage was significantly longer in the nonstented group in comparison with stented group. the average daily amount of leakage was higher in the non-stented group in comparison with stented group but not reach the significant level as shown in Table 5.

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The incidence of cholangitis was reported to be lower in non-stented group when in comparison with stented group but showing non-significant (p= 0.143). Non- significant change has been reported regarding the incidence of biliary leakage and stricture. In non-stented group, only one patient suffered from cholangitis with bile leakage and two patients in stented group had cholangitis that associated with biliary stricture as shown in Table 6.

Discussion

Living donor liver transplantation (LDLT) is a main management method for ESLD.

Biliary reconstructions of alive donor grafts has been performedvia Roux-en-Y enteric or duct to duct anastomosis [9].

However, bile complications still one of the most life threatening morbidities following LDLT, with rates of complications as high as 20–34% for right lobe LDLT.

The elevatedbiliary complication incidencescould be attributed to many reasons; the most important is affecting the blood supplies of both the donors and recipients bile ducts [10].

A main subject of long-term stent settlement is the necessity for periodical stent replacements because of inadequate patency interval of plastic stents. In general, the stent is positioned across the papilla and its distal end is bare to the duodenum. This cancause free reflux of duodenal content via the stent that is supposed to be the main reason of stent occlusions[11].

So in this study, we aimed to find out the percentage of bile complications in the IST group compared to duct-to-duct bile anastomosis with no IST in the 1st 6-mths post- liver transplantations, and to compare the complication percentage connected to the stent tube and its removal via endoscope.

This was a randomized clinical trial, had been carried out at Liver transplant unit at Air Force Specialized Hospital and Nasser Institute Hospital. Thirty caseshave been involved in this research from May 2017 to December 2017 who fulfilled inclusion criteria for liver transplant and the follow-up period was one year. Cases have beendivided into 2 equal groups: Group-A: 15-cases with internal stent, and Group-B:

15-cases with stent-less procedure.

As regard demographic data of the studied groups; we found that Mean± SD of age in stent-less group was 51.33± 12.02 years, and was 54.00± 4.49 years in Stented group, anonsignificant changeswere found amongboth groups in regard to the ages mean at time of operation and gender. Male to female ratio was 2.75 and 1.5 in non-stented and stented group, respectively.Mean ± SD of MELD score was 18.40± 2.85 in stent- less group and was 16.07± 1.75 in stented group, and a significant change was found among the study groups in regard to MELD score, while a nonsignificant change was found among the studied groups concerning CHILD scores.

In agreement with our findings, the study of Kumar et al., [12], aimed to investigate the influence of intra-ductal biliary stents on postoperative bile complications subsequent to LDLT, and reportedthat Mean± SD of age in control group was 48.5 ± 11.6 years, and was 43.4 ± 11.1 years in Stented group, a nonsignificant changes have been found among the study groups in regard to the ages mean at time of operation and gender, on the other hand, as regard MELD score, Mean ± SD was of 21.40± 7.8 in control group and was 25.0 ± 6.8 in stented group, there was no significant change among the study groups.

Extra research done by Rady et al., [9]concluded that Mean± SD of age in stented group was 52.94 ± 6.72 years, and was 50.42 ± 8.46 years in Stent-less group, there

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were nonsignificant changes among the study groups in regard to the mean age at time of operation and gender, the Mean ± SD of MELD score was 18.08 ± 4.91 in stented group and was 18.10 ± 5.43 in stent-less group, and a nonsignificant changes were found among the study groups in regard to MELD score and CHILD score.

In comparison with the resultsbyYazumi et al., [13]which concluded that from July 1999 and July 2005, 273 successive patients experienced RL-LDLT with duct-to-duct bile anastomosis at Kyoto University Hospitals. The cases (114-females and 159- male) ranging between 15 and 70 years old (mean, 48.5-yrs).The mainstream of the caseshave beenmanaged for liver cirrhosis, hepato-cellular cancer, and fulminant hepatic failures.

Biliary complications are the commonest complication afterward LDLT. Bile complications comprise leakages, cholangitis,stricture, bile stones,hemobilia and ductopenia. Risk-factors of complications comprise very old donor ages, multi- anastomoses, long cold and warm ischemia time, hepatic artery thrombosis, and duct- to-duct reconstructions[14].

In the study on our hands, the follow-up period was one year for surviving patients in both groups. Biliary complications were developed in nine patients, two (13.3%) cases in the non-stented group and 3-cases (20%) in the stented group suffered from biliary leakage with nonsignificant change among both groups, 1-case (6.7%) in the nonstented-group suffered from biliary stricture with nonsignificant change among the two groups. 2-cases (13.3%) in the stented-group suffered from biliary stricture with cholangitis. 1-case (6.7%) in the non-stented group suffered from leakage with cholangitis nonsignificant change among both groups. Right lobe graft was the only type of graft represented in all patients.

In the present stud, Post-operative vascular complication occurred in one case only in stented group suffered from bleeding. The event remains statistically insignificant.

In accordance to our findings, the report of Rady et al., [9]reported that The occurrence of biliary leakages and stricture were elevated in group-B (stent-less) (10%) and (14%) as compared to in group-A (stented) (6%) and (8%) respectively, however this was notsignificant, the cholangitis incidence is low in stent-less happened in 3 patients only and are directly related to anastomotic biliary strictures occurred in those 3 patients. Cholangitis in the stented group occurred in 6 patients, cholangitis occurred after the routine cholangiogram after 3 months post transplantation. However, the cholangitis incidence in both groups was nonsignificant.

The use of external biliary stent in duct to duct biliary reconstruction in LDLT facilitate access to the biliary tract, with the possibility of performing a rapid and noninvasive tube-cholangiography and obtaining bile cultures; it also protects the anastomosis from leakage by lowering biliary pressure [15].

A study by Popescu et al., [16] did not show a significant correlation among the use of an external bile stent and a lower rate of bile complications.

A report by Hong et al., [17]concluded that a thick and fitted duct to duct anastomosis via a 6-0 suture can decrease bile leaks without an external biliary drain, but that it would increase biliary strictures afterward LDLTs.

Liu et al., [18] found that the bile leak didn’t rise without usage of an external biliary stent in LDLTs, but that the biliary strictures incidence was at most 24% for a short median following-up interval of 13-mths.

Hamdy et al., [19]reported that thevascular complication incidence of was 36/167 (21.6%) that was allocated into HA (HA stenosis), HAT (a patient with HA aneurysm) or HA injury), PV (PV stenosis or PVT), and HV (HV stenosis or HVT) problems and IVC injuries.

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Rady et al., [9]reported that in thetwo groups’ bile leakagesweretreated conventionally as most of those patients the drain stopped to drain bile spontaneously with only 3 patients required ultrasound guided aspiration and pig tail insertion.

Ishikoet al., [20] aimed toevaluate the practicability and security of duct-to-duct bile anastomosis for LDLTusing the right lobe, and revealed that 5-cases advanced main leakages, with the onsets ranged between 35 and 75-days afterward transplantations.

Leakageswererevealed at the orifice of the division of the6thsegment in 1-case and at the anastomosis in 4-cases. Single case was managed effectively via percutaneous drainages, 2-cases experienced effective operational revisions with the Roux-en-Y method, and 1-case was managed effectively using endoscope nasal drainages.

Kumar et al., [12] reported that 9 patients who developed bile stricture need interventions throughout the following-up interval (14- to 28-mths). Endoscope retrograde cholangiography and stenting has beendone in 6-cases while in 3-cases rendezvous method has been assumed (bile tract was primarily retrieved via percutaneous trans-hepatic route and guiding wire was passed through the anastomotic strictures into duodenum in order to help the endoscope operator in retrieving the biliary duct in a retrograde endoscope fashion for dilatations and stentings).

Choket al., [21]revealed that 50% of the caseshave been effectively managed with endoradiological technique in a small group of cases (n=12) thereafter LDLT. Although endoscopic managementhavethe significance over operativemanagement in treatingthe bile stricture, there is still a necessity for operativemanagement when there are leakages. In a metanalysis of Akamatsu et al., [2]on 2,812 LDLT cases, conflicting to literatureconcludingelevated rates of success of endoscopic management in bile leakages, only 40-cases out of 268-cases with bile leakagescan be managed via endoscope, and the majority of cases (101-cases) have been stated to have experienced surgical operation.

Furthermore, in the current work, the cholangitis incidence was reported to be lower in non-stented group when compared to stented group but showing nonsignificant (p- value= 0.143). No significant difference was reported regarding the incidence of biliary leakage and stricture. In non-stented group, only one patient suffered from cholangitis with bile leakage and two patients in stented group had cholangitis that associated with biliary stricture. Although cholangitis was higher in stented group, its effect on frequency of hospital readmission and the average hospital stay related to these admissions were statistically non-significant (p= 0.123).

Rady et al., [9]reported that the cholangitis incidence is low in DDD happened in 3 patients only and are directly related to anastomotic biliary strictures occurred in those 3 patients, Cholangitis required hospital readmission and administration of antibiotics which was a financial and psychological burden on the patients. However, the cholangitis incidence in both groups was nonsignificant.

Conclusion

Our studysuggested that intra-ductal trans-anastomotic biliary stenting in LDLT can result in relatively same incidence of biliary complications to stent-less anastomosis.Long-term observations can be required to gather adequate data for this managmet modality to become more popular.

Conflict of interest

It would be noticed that there was no association among the authors and any organization or institution. The Authors report no confilcts of interest.

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References:

1. Neuhaus P, Blumhardt G, Bechstein WO, Steffen R, Platz KP, Keck H. Technique and results of biliary reconstruction using side-to-side choledocho-choledochostomy in 300 orthotopic liver transplants. Ann Surg. 1994; 219:426–34.

2. Akamatsu N, Sugawara Y, Hashimoto D. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review of the incidence, risk factors and outcome. TransplIntOff J EurSoc Organ Transplant. 2011; 24:379–92.

3. Sharma S, Gurakar A, Jabbour N. Biliary strictures following liver transplantation:

past, present and preventive strategies. Liver Transplant off Publ Am Assoc Study Liver Dis Int Liver Transplant Soc. 2008; 14:759–69.

4. Duailibi DF, Ribeiro MAF. Biliary complications following deceased and living donor liver transplantation: a review. Transplant Proc. 2010; 42:517–20.

5. Rolles K, Dawson K, Novell R, Hayter B, Davidson B, Burroughs A. Biliary anastomosis after liver transplantation does not benefit from T tube splintage.

Transplantation. 1994; 57:402–4.

6. Shaked A. Use of T tube in liver transplantation. Liver Transplant SurgOffPubl Am Assoc Study Liver Dis Int Liver Transplant Soc. 1997; 3(5 Suppl 1):S22–3.

7. Sherman S, Jamidar P, Shaked A, Kendall BJ, Goldstein LI, Busuttil RW. Biliary tract complications after orthotopic liver transplantation. Endoscopic approach to diagnosis and therapy. Transplantation. 1995; 60:467–70.

8. Tranchart H, Zalinski S, Sepulveda A, Chirica M, Prat F, Soubrane O, et al.

Removable intraductal stenting in duct-to-duct biliary reconstruction in liver transplantation. TransplIntOff J EurSoc Organ Transplant. 2012; 25:19–24.

9. Rady MA, Ahmed A, Mohamed A, Rasha O., and Dalia F. Stentless Duct to Duct Biliary Anastomosis in LDLT Recipients with en Bloc High Hilar Dissection:

Outcomes and Complications, Life Science Journal 2020;17(1).

10. Wadhawan M, Kumar A. Management issues in post living donor liver transplant biliary strictures, World J Hepatol. 2016 Apr 8;8(10):461-70. doi:

10.4254/wjh.v8.i10.461.

11. Koizumi, M., Kumagi, T., Kuroda, T. Endoscopic stent placement above the sphincter of Oddi for biliary strictures after living donor liver transplantation. BMC Gastroenterol 20, 92 (2020). https://doi.org/10.1186/s12876-020-01226-x.

12. Kumar KS, Shaji J, Balakrishnan D, Bharathan VK, Amma BSPT, Gopalakrishnan U, et al. IntraductalTransanastomotic Stenting in Duct-to-Duct Biliary Reconstruction after Living Donor Liver Transplantation: A Randomized Trial, Journal of the American College of Surgeons (2017), doi: 10.1016/j.jamcollsurg.2017.08.024.

13. Yazumi S, Yoshimoto T, Hisatsune H, Hasegawa K, Kida M, Tada S, et al.

Endoscopic treatment of biliary complications after right- lobe livingdonor liver transplantation with duct-to-duct biliary anastomosis. J. HepatobiliaryPancreat. Surg.

2006; 13: 502–10.

14. Abdelaal AA, M A M Hassan, M A M Aboelnaga, M T Rayan, Comparison between Stenting and Stentless Technique in Biliary Anastomosis after Living Donor Liver Transplantation, QJM: An International Journal of Medicine, Volume 113, Issue

Supplement_1, March 2020, hcaa050.046,

https://doi.org/10.1093/qjmed/hcaa050.046.

15. Kirimlioglu V, Tatli F, Ince V. Biliary complications in 106 consecutive duct-toduct biliary reconstruction in right-lobe living donor liver transplantation performed in 1 year in a single center: a new surgical technique. Transplant Proc 2011;43:917-920.

16. Braæoveanu C. Anghel, N. Bacalbaæa, M.I. Ionescu, E. Matei, I. Barbu, M. et al.

Popescu.Technical Aspects of Biliary Reconstruction Correlated with Biliary Complications in 46 Consecutive Right Lobe Liver Transplantations from Living Donors. Chirurgia (2014) 109: 15-19 No. 1, January – February 1

17. Hong S, Xu-Guang Hu, Hyun Young Lee, Je Hwan Won, Jin Woo Kim, Xue-Yin Shen, et al. Long term analysis of Biliary complications after Duct-toDuct Biliary

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reconstruction in living Donor liver transplantations. Liver Transplantation 24 1050- 1061 2018 AASLD.

18. Liu CL, Lo CM, Chan SC, Fan ST. Safety of duct-to-duct biliary reconstruction in right-lobe live-donor liver trans- plantation without biliary drainage. Transplantation 2004; 77:726-732.

19. Hamdy E, Ayman A, Maha L, Mohamed E, and Ahmed A, Complications and mortality after adult to adult living donor liver transplantation: A retrospective cohort study, Ann Med Surg (Lond). 2015 Jun; 4(2): 162–171, Published online 2015 Apr 25. doi: 10.1016/j.amsu.2015.04.021.

20. Ishiko, T., Egawa, H., Kasahara, M., Nakamura, T., Oike, F., Kaihara, S., et al.

(2002). Duct-to-duct biliary reconstruction in living donor liver transplantation utilizing right lobe graft. Annals of surgery, 236(2), 235–240.

https://doi.org/10.1097/00000658-200208000-00012.

21. Chok KS, Chan AC, SharrWWl. Outcomes of endo-radiological approach to management of bile leakage after right lobe living donor liver transplantation. J Gastroenterol Hepatol. 2016;31(1):190–193.

Figure 1 : Intraoperative cholangiography

After one month After 3 months (No stent) Figure 2 : Follow up Abdominal X-ray for stent

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Table (1):Demographic data including age and sex.

Stentless group Stented group

Test value P-valueSig.

No. = 15 No. = 15

Age Mean± SD 51.33± 12.02 54.00± 4.49

0.805* 0.432 NS

Range 20- 65 47 – 65

Sex Male 11 (73.3%) 9 (60.0%)

0.6§ .44 NS

Female 4 (26.7%) 6 (40.0%)

SD= standard deviation, -comparison between groups done by *Mann-Whitney U test,

§Pearson Chi-Square test

Table (2): Demographic data includingMELD and CHILD scores in the study groups Stentless

group Stented group

Test value P-value Sig.

No. = 15 No. = 15

MELD Mean ± SD 18.40± 2.85 16.07± 1.75 40.0• 0.002 S

Range 10- 21 13- 19

CHILD

Mean ± SD 9.44 ± 1.94 10.7 ± 3.16

49.0• 0.78 NS

Range 5 – 11 5 – 14

A 1 6.7% 0 0.0%

3.92 0.141 NS

B 4 26.7% 9 60.0%

C 10 66.7% 6 40.0%

SD= standard deviation, -comparison between groups done by *Mann-Whitney U test, ** chi- square test.

Table (3): Biliary complications found in both groups Stentless group Stented group

Test value

(X2) P-value Sig.

No = 15 No = 15

No. % No. %

No biliary complications 11 73.3% 10 66.7% 0.16 0.69 NS

Leakage 2 13.3% 3 20.0% 0.24 0.624 NS

Stricture 1 6.7% 0 0.0% 1.03 0.309 NS

Stricture with cholangitis 0 0.0% 2 13.3% 2.14 0.143 NS

Leakage with cholangitis 1 6.7% 0 0.0% 1.03 0.309 NS

Table (4): Diagnosis of complications found in both groups Stentless group Stented group

Test value

(X2) P-value Sig.

No = 15 No = 15

No. % No. %

US 3 20.0% 3 20.0% 0.0 1.00 NS

MRCP & ERCP 0 0.0% 1 6.7% 1.03 0.309 NS

US, MRCP & ERCP 1 6.7% 1 6.7% 0.0 1.00 NS

Table (5): Average amount of leakage per day and average duration till occurrence of leakage

Total leakage

Stentless Group

Stented

Group Test

value P-

value Sig.

No. = 3 No. = 3 Duration till occurrence of leakage

(days)

Mean± SD 5.00± 1.00 1.67± 1.15

3.78 0.019 S

Range 4- 6 1- 3

Average daily amount of leakage/24 hrs. (ml)

Mean± SD 583.33±76.38 400.00± 86.60

2.75 0.052 NS

Range 500- 650 350- 500

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Table (6): Frequency of admission and average hospital stay due to cholangitis in both groups

Cholangitis Non stented Stented

Test value P-value Sig.

No. = 1 No. = 2

Frequency of admission 2 days 1 (100%) 2 (100%) 3.04 0.123 NS Average hospital stays 3 days and 4 days 0 (0%) 2 (100%)

3.04 0.123 NS

4 days and 2 days 1 (100%) 0 (0%)

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