1. Catheter-based Suture-free Hepaticojejunostomy John Seal MD Research Resident University of Chicago Department of Surgery Giuliano Testa MD Associate Professor University of Chicago Department of Surgery Transplantation Thuong VanHa MD Associate Professor University of Chicago Department of Radiology Interventional Radiology

2. Hepatico-jejunostomy –Connection between the bowel (jejunum) and the common bile duct –Typically performed as final anastomosis of orthotopic liver transplant (OLT) –Also used in hepatobiliary operations involving resection of common bile duct (Whipple, choledochal cyst, trauma) –Anastomosis typically near liver parenchyma Hepatico-jejunostomy

3. Bile Leak Anastomotic Stricture –Common complications of liver transplantation –Requires multiple endoscopic procedures Stent / dilation –Requires re-operations for anastomosis revision –Can lead to Liver failure Re-transplantation Infection Death Complication

4. Reasons for failure –Poor blood supply –Suture ischemia –Hepatic artery thrombosis –Tension –Bowel edema –Hypotension –Prolonged warm ischemia –Technical error (fatigue) Complications of Hepaticojejunostomy

5. Temporarily anchor bowel to transected common bile duct Percutaneous, transhepatic catheter into common bile duct Deploy anchoring device into lumen of jejunum to approximate CBD and bowel Anastomosis forms from inflammatory reaction / fibrosis Patency maintained with intralumenal catheter No sutures / tension to produce ischemia Anchoring device removed after anastomosis secure Catheter used to maintain patency, ultimately removed Proposal for Suture-free Anastomosis

6. SKIN COMMON BILE DUCT LUMEN JEJUNUM LIVER “UMBRELLA” ANCHOR DEVICE CATHETER INTRODUCER

7. 2 pigs (110 lb) Surgery –Midline laparotomy –Transection of common bile duct –Introduction of catheter and anchor device –Retraction and anchor to liver bed Bowel pulled up without Roux-en-Y reconstruction Pig #2 “Omega Loop” to divert alimentary flow –Secured externally in subcutaneous pocket –Cholangiogram –2 week survival Repeat cholangiogram / gross inspection Pilot Study Omega Loop

8. Ablation Umbrella Device

9. Diameter 2.0 cm

10. Percutaneous Catheter Placement

11. Tract Through Hepatic Parenchyma

12. Catheter through Common Bile Duct

13. Anchor deployed in lumen

14. Tip of catheter in intestinal lumen Bowel closely approximated to liver margin with anchor Device Deployed and Anchored

15. Cholangiogram at 1 st Operation

16. 1st pig Contrast in bowel lumen Leak from first introducer pass

17. 2nd pig

18. Pig #1 –Concern for false tract, potential leak Initially recovered well No distress, peritonitis, abnormal fever Persistent lethargy, poor PO intake –Sacrificed at 10 days No bile / bile staining or evidence of bile leak No enteric spillage / purulence Markedly dilated bowel proximal to anastomosis Patchy dark discoloration in colon / distal bowel Anastomosis adherent / secure No infection or bile in subcutaneous pocket Results

19. Pig #1 Cholangiogram at sacrifice

20. No Evidence of Bile Leak Dilated ProximallyDecompressed Distally

21. Anastomosis

22. Pig #2 –Omega loop to divert alimentary flow Normal recovery Good PO intake, bright, alert No abnormal fever –Sacrificed at 14 days No bile / bile staining or evidence of bile leak No enteric spillage / purulence Anastomosis adherent / secure No evidence of obstruction, omega loop intact / patent Skin breakdown / erosion over catheter pocket Results

23. Pig #2 Cholangiogram at sacrifice

24. Fibrosis and adhesion of anastomosis

25. Secure anastomosis / device in place

26. Pilot Study –Technically feasible approach for “suture-free” hepatico-jejunostomy anastomosis Well-tolerated in short term No bile leak Patent anastomosis Future directions Suture-free device vs. standard approach (hand-sewn) Mechanism for anchor removal Longer follow-up to evaluate patency Apply in animal model of liver transplant Conclusions

27. Design Modification New anchoring techniques –Intraluminal balloon –Low profile expandible disc (Boomerang) –New umbrella materials / design Improve deployment / retrieval mechanism –Interlocking hook system –Embedded retraction sheath in catheter

28. Acknowledgments Funding for Pilot Study and Prototype Device University of Chicago Department of Radiology Section of Vascular and Interventional Radiology Animal Resource Center Craig Wardrip, DVM Marek Niekrasz, DVM Maggie Bruner Jennifer McGrath Karin Peterson