Is A Post Transection Bile Leak Test Now Standard of Care in Liver Surgery?

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1 Is A Post Transection Bile Leak Test Now Standard of Care in Liver Surgery? Thomas Aloia, MD Director of Quality and Outcomes Head, Institute for Cancer Care Innovation MD Anderson Cancer Center

2 None Disclosures

3 Is A Post Transection Bile Leak Test Now Standard of Care in Liver Surgery? Thomas A. Aloia, MD Department of Surgical Oncology Hepatobiliary Surgery Section

4 Postoperative Bile Leak International Study Group of Liver Surgery 2010 Definition: - Increased Drain Bilirubin Concentration (x3 Serum Concentration) on POD3 or Later - Need for Radiological or Surgical Procedure for Bile Collection(s) Grade: A B C No or little Change in Clinical Management Change in Management (Additional Diagnostic or Interventional Procedures) without Relaparotomy Bile Leak Requiring Relaparotomy Koch et al, Surgery 2011

5 Postoperative Bile Leak Incidence Country Year Patient # Bile Leak % Mortality % USA Italy China Japan Jarnagin et al Ann Surg 2002, 2 Capussotti et al. Arch Surg 2006, 3 Lo et al. Arch Surg 1998, 4 Imamura et al. Arch Surg 2003

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7 Postoperative Bile Leak Risk factors Author Yamashita Y, 2001 Li SQ, 2007 Nagano Y, 2003 Capussotti L, 2006 High risk procedures Anterior Segmentectomy Caudate Lobectomy Left hepatectomy Left trisectionectomy Anterior and Central Segmentectomy Anterior and Central Segmentectomy Subsegmentectomy S4-5-8

8 MDACC Experience Liver Resections 97 Bile Leaks (4%) 2 Deaths (2.1%) Treatment # Medical 43 Percutaneous Drainage 48 ERCP 13 PTC 7 Surgery 2 Zimmitti, 2013 in press

9 MDACC Experience Liver Resections =3.7% =5.9% Risk Factors: bile duct resection, extended hepatectomy, repeat hepatectomy, en-bloc diaphragmatic resection and intraoperative transfusion Zimmitti, 2013 in press

10 MDACC Experience Multivariate Analysis Major Two Stage Transfusion Hepatectomy Hepatectomy Bile Leak P= P= P< ( ) ( ) ( ) Zimmitti, 2013 in press

11 Bile Leak and VTE #1 risk factor for VTE is postoperative bile leak 8x incidence of VTE Immobility Inflammation Invasive procedures Prolonged LOS Tzeng, HPB 2013 in press

12 Bile Leak: The Achilles Heal of Liver Surgery Needs a prevention strategy! The Bile Leak Test?

13 Optimal Screening Test Characteristics Addresses a problem of importance with a significant incidence treatable Safe/Noninvasive Inexpensive Simple/Rapid Repeatable Accurate Sensitive Specific

14 Historical References: BLTs Author, Journal Year Method Lo, Arch Surg 1998 Cholangiography Ijichi, Arch Surg 2000 RCT Saline Lam, WJSurg 2001 Methylene Blue Suehiro, Transp 2005 ICG Nadalin, Arch Surg 2008 Emulsified fat Kiabori, Surg 2011 ICG Zirrinpar, HPB 2012 Hydrogen peroxide Zimmitti, JACS 2013 Air Karavias, Ann R Coll Surg Eng 2014 Propofol

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16 Prevention of Postoperative Bile Leak Non-randomized Studies Author Method Patient # P value Capussotti, 2006 Surface fibrin glue Li, 2009 Fat Emulsion Karaliotas, 2000 Methylene Blue 78 <.02 Yamashita, 2001 ICG Sakaguchi, 2010 ICG + PDE 59 NS ICG: Indocyanine Green; PDE: Photodynamic Eye

17 Bile Leak Test RCTs and Trials Study Design Comparison Material Ijichi et al[11], (2000) Liu et al[13], (2012) Li et al[12], (2009) Suehiro et al[24], (2005) Lam et al[2], (2001) Leelawat et al[26], (2012) RCT RCT Controlled clinical trial Controlled clinical trial Controlled clinical trial Controlled clinical trial BL Test vs N- BL Test BL Test vs N- BL Test BL Test vs N- BL Test BL Test vs N- BL Test BL Test vs N- BL Test White Test vs Saline Solution Test Saline solution Sample (trial:control) 51:51 Fat emulsion 53:54 Fat emulsion 57:70 ICG 40:40 Methylene blue 304:312 Fat emulsion 30:30 Inclusion criteria Liver resection Liver resection Major liver resection Liver resection Liver resection Liver resection Liver disease Country Tumor Tumor or hepatolithiasis Tumor Liver donor Tumor Tumor Japan China Germany Japan Hong Kong Thailand Sakaguchi et al[27], (2010) Controlled clinical trial ICGF Test vs N-ICGF Test ICG 27:32 Liver resection Tumor Japan Kaibori et al[25], (2011) RCT ICGF Test vs N-ICGF Test ICG 52:50 Liver resection Tumor Japan

18 Prevention of Postoperative Bile Leak Randomized Studies Author Patient # Leak (%) P value Figueras, 2007 Fibrin glue (10) NS No fribin glue (11) Ijichi, 2000 Isotonic Sodium Cloride 51 3 (6) NS Nothing 51 2 (4) Kaibori, 2011 ICG + PDE 52 5 (10).019 ICG 50 0 ICG: Indocyanine Green; PDE: Photodynamic Eye

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20 Prevention of Postoperative Bile Leak Disadvantages of Dye Techniques Staining of Surgical Field Difficulty to Repeat No Direct Evaluation (PDE) Complexity of the Technique

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22 Post Transection Air Leak Test Prep Cannulate the cystic duct, manually occlude the distal common duct Part 1 Inject air with ultrasound visualization of liver parenchyma Part 2 Identifies patency of the hilum Mult follow doppler examination of the blood vesell flow Inject air with liver surface submerged to identify air leaks Oversew leaks and repeat.

23 Two-Step Bile Duct Evaluation Step 1: Pneumobilia Test Cholangiogram Catheter in common bile duct and occlusion of DBD Presence of Pneumobilia by Ultrasonography Patent Bile Duct System Absence of Pneumobilia Bile Duct Obstruction / Massive Air Leak

24 Two-Step Bile Duct Evaluation Step 2: Air Leak Test Air Insufflated while Right Upper Quadrant is Filled with Saline

25 Two-Step Bile Duct Evaluation Step 2: Air Leak Test Air Insufflated while Right Upper Quadrant is Filled with Saline

26 Two-Step Bile Duct Evaluation Preliminary Results From 2/2010 to 9/ Consecutive Major Hepatectomy 31 Intraoperative Air Leaks in 23 patients Right/ Left Bile Duct Stump: 15 Parenchymal Transection Plane: 16 No Postoperative Bile Leak (0/41)

27 Multi-institutional study Centers (US and Italy) 223 patients 103 ALT matched non-alt All basic patient, tumor, operative variables equal Intraoperative open bile duct repair 62.1% vs. 8.3% Postoperative bile leak 1.9% vs. 10.8% LOS with bile leak 6 vs. 21 days

28 Global Outcomes with ALT MDACC ACS-NSQIP Hepatectomy Outcomes Low outlier Mortality Morbidity LOS OSI VTE

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30 To Drain or Not to Drain? Mandatory Drainage Drainage Recommended No Need to Drain Diaphragm Reconstruction Contaminated Bile Ducts Bilioenteric Anastomosis Minor resection or Anatomic Resection + Negative Bile Leak Test

31 Is A Post Transection Bile Leak Test Now Standard of Care in Liver Surgery? YES!

32 Adopted?? Standard of Care Multicenter Randomized Trial 2018 Bile leak test (any) vs none Sub-stratify Drain vs No Drain MDACC (IRB/Data Center) ACS NSQIP HPB collaborative AHPBA SSO SSAT

33 CONTACTS Thomas A. Aloia, MD Department of Surgical Oncology Hepatobiliary Surgery