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859 Prospective International Multicenter Study on EUS-Guided Biliary Drainage for Patients With Distal Malignant Biliary Obstruction and Failed ERCP
Abstracts
857 Evaluation of Tumour Angiogenesis in Colorectal Cancer Based on Quantitative Contrast-Enhanced Endoscopic Ultrasonography and Molecular Analysis Elena Tatiana Cartana*1, Ioana Streata2, Elena-Raluca Nicoli2, Daniel Uscatu2, Adriana M. Ciocalteu1, Irina F. Cherciu1, Dan Ionut Gheonea1, Claudia-Valentina Georgescu3, Mihai I. Ioana2, Gabriel Gruionu1,4, Adrian Saftoiu1,5 1 Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy of Craiova, Craiova, Romania; 2Human Genomics Laboratory, University of Medicine and Pharmacy of Craiova, Craiova, Romania; 3Department of Pathology, Emergency County Hospital, Craiova, Romania; 4Steele Laboratory of Tumour Biology, Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA; 5Department of Endoscopy, Copenhagen University Hospital Herlev, Copenhagen, Denmark Introduction: Contrast-enhanced endoscopic ultrasonography (CE-EUS) is a high resolution minimally invasive imaging technique that enables better characterisation of lesions based on the assessment of perfusion features. Data on the use of contrast-enhanced ultrasonography for the real-time assessment of angiogenesis in colorectal cancer (CRC) is limited. Aims & Methods: The aim of the current study was to evaluate tumour vascularity in CRC by CE-EUS with time intensity curve (TIC) analysis backed by assessment of molecular markers of angiogenesis. We prospectively included patients with both colonic and rectal tumours that were examined using a radial forward-viewing echoendoscope prior to any therapy. CE-EUS was performed in a low mechanical index mode (0.2) after bolus injection of the contrast agent (4.8 ml of Sonovue, Bracco, Italy). A dedicated software was used for offline TIC analysis of the recorded video sequences (VueBoxÔ, Bracco) and several parameters were determined, including peak enhancement (PE), rise time (RT), mean transit time (mTT), time to peak (TTP) and area under the curve (AUC). For gene analysis endoscopic biopsies of CRC tumour and adiacent normal tissue were collected in RNAlater solution and stored at -80OC until mRNA was extracted. Gene expression of VEGFR1 and VEGFR2 was measured by two-step qRT-PCR using TaqMan technology. Results: In total, 45 CE-EUS video sequences were analysed. Most of the tumours were well vascularized with uptake of the contrast agent during the arterial phase, and only 3 tumours (6.7%) were hypoenhancing. The mean values (SEM) for PE, RT, mTT, TTP and AUC were: 37.2510.17 a.u, 9.260.97 s, 92.8414.43 s, 12.621.21 s and 637.36175.08 a.u, respectively. Gene expression was assessed in 32 paired samples, revealing that VEGFR1 and VEGFR2 are expressed in both tumour and normal mucosa. Total VEGFR1 expression was elevated in tumour tissue compared with paired normal mucosal samples in 21 cases (65.62%); in 4 cases (12.5%) expression was higher in normal mucosa and in the remaining 7 cases (21.88%) the difference between paired samples was biologically insignificant. VEGFR2 expression was increased in tumour tissue compared with paired normal mucosal samples in 16 cases (50.00%); in 4 cases (12.5%) the expression was higher in normal tissue and in the remaining 12 cases (37.5%) the difference between paired samples was biologically insignificant. Conclusion: CEEUS examination with TIC analysis enables minimally invasive assessment of CRC angiogenesis. However further investigation and validation of the examination technique on larger groups of patients is needed.
858 Metal or Plastic Stents to EUS - Guided CholedochoDuodenostomy : a Prospective Trial Everson L. Artifon*, Carlos K. Furuya, Marco Antonio B. Cunha, Ricardo S. Uemura, Luca Alvares, Augusto Naves Endoscope Departament, Hospital Ana Costa, Sao Paulo, Brazil Background: EUS-guided biliary access is an alternative for percutaneous access or surgery in patients with malignant unresectable distal biliary obstruction. When rendezvous or anterograde transpapillary/transanastomotic intervention fails as primary drainage options, a choledochoduodenostomy (CD) or a hepaticogastrostomy (HG) can still be performed in selected patients. CD is more frequently performed and there are no studies that recommend or metal or plastic stents in this procedure. Aim To compare technical and clinical success and possible associated factors between the two different Stents in patients with distal unresectable malignant biliary obstruction that failed standard ERCP, EUS-guided RV maneuver or anterograde stent placement. Patients and Methods: Between March/2012 and July/2014 60 consecutive jaundiced patients with distal unresectable malignant biliary obstruction that failed previous ERCP and EUS-guided RV maneuver or anterograde stent placement were elected randomly to undergo either Metal or plastic stents. Data including indications, clinical and technical success, procedural times and complications with a 3-month follow-up were prospectively collected in a database from three international institutions. All procedures were performed in three tertiary center by experienced endoscopists. A partially covered SEMS (10 mm, 8 cm or 6 cm) and plastic stent (10Fr x 7 cm) were used. After puncture of the distal unobstructed segment of common bile duct a cholangiogram was obtained followed by advancement of a 0,035-inch guide wire into the biliary system. Bougies and wireguided needle-knife were used to perform track dilation to allow passage of an 8.5 Fr
www.giejournal.org
stent delivery system. Results: Sixty cases (30 Metal and 30 plastic) were performed. Indications for the drainage procedures are shown in the table. All patients had intra and extra hepatic biliary dilation. The median procedural time was 36.60 min for Metal and 30.41 min for Plastic (pZ0,37) groups. Technical success rate was 95 % for metal and 91% for plastic (pZ0,50). The type of stent was not associated with technical success difference in this study (pZ0,36). In The Metal group, 4 patients (13.4%) had immediate complications (3 bleeding, 1 biloma) and Plastic group, 7patients (23.4%) had immediate complications (4 biloma, 1 bleeding ,1 bacteremia and 1 perforation), (pZ 0.039). All complications were managed clinically, including the perforation patient. The cost analysis were significantly in favor to metal stent group (pZ0.041). Conclusion: No significant difference was found in regards to procedure time, technical or clinical success. Complications and total costs were significantly higher in the plastic group. Outcomes might be more related to the endoscopist personal experience with one or the other type of stent.
Procedural indications for biliary drainage
Metal Plastic Total
Panc. Cancer
Ext. Compression
Papilla Tumor
Neuroendocrine
GB Tumor
Duodenal Tumor
19 15 34
5 4 9
4 5 9
1 4 5
0 0 0
1 2 3
Total
859 Prospective International Multicenter Study on EUS-Guided Biliary Drainage for Patients With Distal Malignant Biliary Obstruction and Failed ERCP Mouen Khashab*1, Schalk Van Der Merwe2, Rastislav Kunda3, Mohamad H. El Zein1, Anthony Y. Teoh4, Fernando P. Marson5, Carlo Fabbri6, Ilaria Tarantino7, Shyam Varadarajulu8, Rani J. Modayil9, Stavros N. Stavropoulos9, Irene PeñAs10, Saowanee Ngamruengphong1, Vivek Kumbhari1, Joseph Romagnuolo12, Lindsay Hosford11, Manuel Perez-Miranda10, Everson L. Artifon5 1 Johns Hopkins Medical Institute, Baltimore, MD; 2University Hospital KU Leuven, Leuven, Belgium; 3Aarhus University, Aarhus, Denmark; 4 The Chinese University of Hong Kong, Hong Kong, China; 5Ana Costa Hospital, Sao Paulo, Brazil; 6AUSL Bologna Ospedale Bellaria-Maggiore, Bologna, Italy; 7Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Palermo, Italy; 8Florida Hospital, Orlando, FL; 9Winthrop University Hospital, Mineola, NY; 10Hospital Universitario Rio Hortega, Calle Dulzaina, Spain; 11University of Colorado Denver, Denver, CO; 12Medical University of South Carolina, Charleston, SC Background: EUS-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures. However, prospective multicenter data are lacking. Aims: The primary outcome of this prospective study (NCT01889953) was to assess the clinical success of EUS-BD. Secondary outcomes included technical success, rate and severity of adverse events, and long-term outcomes of EUS-BD. Methods: All consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal (R 2cm from the hilum) biliary obstruction and failed ERCP underwent EUS-BD using either rendezvous (REN), direct transluminal (TL) [Choledochoduodenostomy (CDS), Hepatogastrostomy (HGS), Hepatoduodenostomy (HDS)], or antegrade (AG) stenting techniques. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as drop in bilirubin by 50% at 2 weeks or to below 3 (level that allows patients to undergo chemotherapy) at 4 weeks. Adverse events were prospectively tracked and graded according to the ASGE lexicon’s severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier estimate. Results: A total of 95 patients (mean age 66yr, female 44%, pancreatic cancer 55%) underwent EUS-BD [REN 11, AG 12, TL 72 (CDS 53, HGS 15, HDS 4)]. Reason for EUS-BD was obscured ampulla by invasive cancer or enteral stent (nZ49), altered anatomy (nZ9), failed deep biliary cannulation (nZ20), gastric outlet obstruction (nZ17). Electrocautery was used during 66.67% of procedures (coaxial 38.67%, non-coaxial 28%). EUS-guided cholangiography was successful in 94 (99%) patients. Stent placement (technical success) was achieved in 91 (95.7%) patients (metallic stent 83, plastic stent 8). Mean procedure time was 41 minutes (range 8-207). Clinical success was achieved in 85 patients (95%, intention to treat; 89.4%, per protocol analysis). There was significant decrease in bilirubin (mg/dL) at 4 weeks (13.9 vs. 1.86, p!0.0001). A total of 10 (10.5%) adverse events occurred: pneumoperitoneum (nZ2), sheared wire (nZ1), bleeding (nZ1), bile leak (nZ3), cholangitis (nZ2), and perforation (nZ1): 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). There were no predictive factors of clinical success or occurrence of adverse events (all pO0.05). A total of 24 (25%) patients died of disease progression during the study period. The median patient survival was 491 days. The mean stent patency was 536 days (95% CI 383-689) and the one-year stent patency was 61% (Figure 1). Conclusion: This is the first prospective international multicenter study on EUS-BD and demonstrates the excellent
Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB175
Abstracts
efficacy and safety of EUS-BD when performed by experts. Based on these results, a study comparing EUS-BD to percutaneous drainage is being planned.
Figure 1. Kaplan Meier estimate of stent patency
881 Endoscopic Rendezvous Procedure to Treat a Complete Ileorectal Anastomotic Stricture Larissa L. Fujii*1, Faris Murad2 1 Division of Gastroenterology and Hepatology, Washington University, St. Louis, MO; 2Divison of Gastroenterology and Hepatology, Washington University, Washington University, MO Background/Case: A 29 year old female with a history of fistulizing perianal and stricturing ileocolonic Crohn’s disease underwent a total abdominal colectomy with loop ileostomy formation for complications related to her inflammatory bowel disease. Her perianal disease healed with diversion of her fecal contents and her remaining disease was controlled on combination therapy. Prior to her ileostomy takedown, she had a lower GI study which showed a blind-ending pouch that filled to the level of the sutures, but no contrast passed the ileorectal anastomosis. With the surgeon’s approval, the patient was scheduled for an endoscopic rendezvous procedure to treat the complete anastomotic stricture. Endoscopic Methods: After confirming that no opening was visualized from the rectal pouch, the upper endoscope was introduced through the ileostomy to the blind end. To mark the anastomosis site from the ileum, one hemoclip was placed near the presumed anastomosis and contrast was injected to fill the ileal blind limb. The scope was reinserted into the rectum to the anastomosis, and fluoroscopy confirmed that the scope was !1 cm from the contrast in the ileum. Under fluoroscopic guidance, a 19-gauge EUS FNA needle was introduced through the scope and used to localize the area to puncture. The EUS needle was passed into the ileum, followed by a 0.035 inch guidewire. The tract was dilated with the tip of the EUS needle, followed by sequential TTS balloon dilators to a maximum of 12 mm. Finally, three plastic double pigtail stents were placed to keep the tract open. Following the procedure, the patient did well. She underwent two further dilations to a maximum of 18 mm. This adequately opened the anastomosis to allow takedown of her loop ileostomy 5 months later. Clinical Implications: This case highlights an alternative technique for establishing bowel continuity in patients with significant strictures. It was a safe and effective procedure that used standard endoscopic equipment that should be available in any endoscopy unit. The benefit of reestablishing a patent ileorectal anastomosis was that it ultimately allowed the patient to undergo her desired ileostomy takedown.
882 Rendezvous Endoscopic Access and Closure of Large Enterocutaneous Fistula Using Polyglactin Mesh and an Over-the-Scope Clip Shounak Majumder*, Victoria Gomez, Navtej Buttar, Nayantara Coelho Prabhu, Louis M. Wong Kee Song Mayo Clinic, Rochester, MN Background/Case: The management of post-op enterocutaneous (EC) fistulas is challenging. Treatment options are limited and the majority of patients with high
AB176 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
output drainage require repeat surgery, which is associated with significant morbidity and mortality. An 84-year-old woman with complex Crohn’s colitis, statuspost proctocolectomy with end ileostomy, had a post-op course complicated by surgical wound infection and a high output EC fistula interfering with stoma care and resulting in dehydration. She was deemed a poor surgical candidate and was referred for an attempt at endoscopic closure. Endoscopic Methods: A contrast study through the ileostomy showed a tortuous, angulated small bowel pathway to the fistula, and located about 80 cm proximal to the ileostomy. An attempt at reaching the fistula using an upper endoscope and a pediatric colonoscope through the ileostomy was unsuccessful. A rendezvous endoscopic procedure was thus performed in an attempt to access and close the fistula. An upper endoscope, inserted through the ileostomy, was advanced as far as possible toward the fistula. A smallcaliber pediatric endoscope, inserted through the EC fistula, was advanced toward the ileostomy until both endoscopes were in a rendezvous position. Next, a guidewire was passed from the upper endoscope into the pediatric endoscope to exit the fistula site. Both endoscopes were withdrawn, leaving the guidewire in place. Over the guidewire, the upper endoscope fitted with an over-the-scope clip (OTSC) was inserted through the ileostomy and advanced to the fistula site. By keeping the guidewire taut at both ends, the OTSC-loaded endoscope was advanced successfully to the fistula site. Once in position, the guidewire was removed. The rim of the fistula was de-epithelialized using APC. A 2 x 2 in2 folded polyglactin mesh was placed in the fistula tract from the skin side. The mesh-embedded fistula was then closed by deploying the OTSC. Following clip deployment, endoscopic methylene blue instillation showed no visible leakage of the dye externally, consistent with satisfactory fistula closure. At 2-week follow-up, very minimal fistula output was observed. At last follow-up 6 months post-procedure, the fistula site had healed without repeated intervention. Clinical Implications: The rendezvous endoscopic approach may be a potential option for accessing large EC fistulas that are otherwise not reachable by standard endoscopic means, and to enable multimodal therapy, such as fistula tract ablation, mesh placement and clip closure, particularly in patients with comorbidities or an inhospitable abdomen that preclude surgical intervention.
883 Efficacy of Magnetic Marking Clip Method for Pre-Operative Localization of Gastrointestinal Tumor Seung Han Kim*, Bora Keum, in Kyung Yoo, Jae Min Lee, Seung-Joo Nam, Hyuk Soon Choi, Eun Sun Kim, Yoon Tae Jeen, Hongsik Lee, Hoon Jai Chun, Chang Duck Kim, Ja Seol Koo Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (the Republic of) Background/Case: As laparoscopic surgery has been mainly used to resect gastrointestinal (GI) tumors, the importance of tumor localization has been addressed. Without exact tumor localization, resection of unnecessary excess tissue may be happened or surgeons could not secure enough resection margin. Until now, various methods were suggested for the localization of GI tumor in laparoscopic surgery; however there have been several limitations in these methods. This study aimed to assess efficacy and feasibility of a novel method in tumor localization. We enrolled 13 patients with gastric submucosal tumor and 12 patients with early colorectal cancer. Endoscopic Methods: We devised magnetic marking clip (MMC) that was silicon coated 10mm sized ring magnet fixed to endoclip using 3-0 nylon. MMC was applied on the center of lesion during preoperative endoscopy. During surgery, magnetic body which was hanged with long thread which was inserted through laparoscopic trocar, was used tofind tumor lesion which marked by MMC. We analyzed tumor etection rate, detection time, proximal & distal margin from lesion and procedure associated complication. Results: In 13 patients, tumors were located in the stomach and 12 patients in colon. Tumor size ranged from 12 to 18 mm in stomach and 10 to 18 mm in colon. MMC were successfully detected in 25 of 25 patients (100%) in laparoscopic surgery. The time required for detection ranged from 10 to 35 sec in stomach and 20 to 85 sec in colon. The resected margin from lesion ranged from 5 to 30 mm in stomach and 40 to 50mm in colon. None of our patients experienced complications associated with MMC procedure. Clinical implication: MMC method was simple and convenient in tumor localization, and showed excellent outcomes for accuracy of tumor localization and detection rate. Also, there were no procedure associated complications. MMC method could help surgeons to easily localize tumor lesion during laparoscopic surgery.
884 Needle Knife Stricturoplasty of a Benign Colorectal Anastomotic Stricture A. Aziz Aadam*, Shakthi D. Kumar, Jennafer Ottenheimer, Peter J. Sargon Division of Gastroenterology, Rush University Medical Center, Chicago, IL This is a 56 Y male with history of colon cancer. He underwent a sigmoidectomy in 2011 with a loop colostomy. Surgery was complicated by an
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857 Evaluation of Tumour Angiogenesis in Colorectal Cancer Based on Quantitative Contrast-Enhanced Endoscopic Ultrasonography and Molecular Analysis Elena Tatiana Cartana*1, Ioana Streata2, Elena-Raluca Nicoli2, Daniel Uscatu2, Adriana M. Ciocalteu1, Irina F. Cherciu1, Dan Ionut Gheonea1, Claudia-Valentina Georgescu3, Mihai I. Ioana2, Gabriel Gruionu1,4, Adrian Saftoiu1,5 1 Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy of Craiova, Craiova, Romania; 2Human Genomics Laboratory, University of Medicine and Pharmacy of Craiova, Craiova, Romania; 3Department of Pathology, Emergency County Hospital, Craiova, Romania; 4Steele Laboratory of Tumour Biology, Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA; 5Department of Endoscopy, Copenhagen University Hospital Herlev, Copenhagen, Denmark Introduction: Contrast-enhanced endoscopic ultrasonography (CE-EUS) is a high resolution minimally invasive imaging technique that enables better characterisation of lesions based on the assessment of perfusion features. Data on the use of contrast-enhanced ultrasonography for the real-time assessment of angiogenesis in colorectal cancer (CRC) is limited. Aims & Methods: The aim of the current study was to evaluate tumour vascularity in CRC by CE-EUS with time intensity curve (TIC) analysis backed by assessment of molecular markers of angiogenesis. We prospectively included patients with both colonic and rectal tumours that were examined using a radial forward-viewing echoendoscope prior to any therapy. CE-EUS was performed in a low mechanical index mode (0.2) after bolus injection of the contrast agent (4.8 ml of Sonovue, Bracco, Italy). A dedicated software was used for offline TIC analysis of the recorded video sequences (VueBoxÔ, Bracco) and several parameters were determined, including peak enhancement (PE), rise time (RT), mean transit time (mTT), time to peak (TTP) and area under the curve (AUC). For gene analysis endoscopic biopsies of CRC tumour and adiacent normal tissue were collected in RNAlater solution and stored at -80OC until mRNA was extracted. Gene expression of VEGFR1 and VEGFR2 was measured by two-step qRT-PCR using TaqMan technology. Results: In total, 45 CE-EUS video sequences were analysed. Most of the tumours were well vascularized with uptake of the contrast agent during the arterial phase, and only 3 tumours (6.7%) were hypoenhancing. The mean values (SEM) for PE, RT, mTT, TTP and AUC were: 37.2510.17 a.u, 9.260.97 s, 92.8414.43 s, 12.621.21 s and 637.36175.08 a.u, respectively. Gene expression was assessed in 32 paired samples, revealing that VEGFR1 and VEGFR2 are expressed in both tumour and normal mucosa. Total VEGFR1 expression was elevated in tumour tissue compared with paired normal mucosal samples in 21 cases (65.62%); in 4 cases (12.5%) expression was higher in normal mucosa and in the remaining 7 cases (21.88%) the difference between paired samples was biologically insignificant. VEGFR2 expression was increased in tumour tissue compared with paired normal mucosal samples in 16 cases (50.00%); in 4 cases (12.5%) the expression was higher in normal tissue and in the remaining 12 cases (37.5%) the difference between paired samples was biologically insignificant. Conclusion: CEEUS examination with TIC analysis enables minimally invasive assessment of CRC angiogenesis. However further investigation and validation of the examination technique on larger groups of patients is needed.
858 Metal or Plastic Stents to EUS - Guided CholedochoDuodenostomy : a Prospective Trial Everson L. Artifon*, Carlos K. Furuya, Marco Antonio B. Cunha, Ricardo S. Uemura, Luca Alvares, Augusto Naves Endoscope Departament, Hospital Ana Costa, Sao Paulo, Brazil Background: EUS-guided biliary access is an alternative for percutaneous access or surgery in patients with malignant unresectable distal biliary obstruction. When rendezvous or anterograde transpapillary/transanastomotic intervention fails as primary drainage options, a choledochoduodenostomy (CD) or a hepaticogastrostomy (HG) can still be performed in selected patients. CD is more frequently performed and there are no studies that recommend or metal or plastic stents in this procedure. Aim To compare technical and clinical success and possible associated factors between the two different Stents in patients with distal unresectable malignant biliary obstruction that failed standard ERCP, EUS-guided RV maneuver or anterograde stent placement. Patients and Methods: Between March/2012 and July/2014 60 consecutive jaundiced patients with distal unresectable malignant biliary obstruction that failed previous ERCP and EUS-guided RV maneuver or anterograde stent placement were elected randomly to undergo either Metal or plastic stents. Data including indications, clinical and technical success, procedural times and complications with a 3-month follow-up were prospectively collected in a database from three international institutions. All procedures were performed in three tertiary center by experienced endoscopists. A partially covered SEMS (10 mm, 8 cm or 6 cm) and plastic stent (10Fr x 7 cm) were used. After puncture of the distal unobstructed segment of common bile duct a cholangiogram was obtained followed by advancement of a 0,035-inch guide wire into the biliary system. Bougies and wireguided needle-knife were used to perform track dilation to allow passage of an 8.5 Fr
www.giejournal.org
stent delivery system. Results: Sixty cases (30 Metal and 30 plastic) were performed. Indications for the drainage procedures are shown in the table. All patients had intra and extra hepatic biliary dilation. The median procedural time was 36.60 min for Metal and 30.41 min for Plastic (pZ0,37) groups. Technical success rate was 95 % for metal and 91% for plastic (pZ0,50). The type of stent was not associated with technical success difference in this study (pZ0,36). In The Metal group, 4 patients (13.4%) had immediate complications (3 bleeding, 1 biloma) and Plastic group, 7patients (23.4%) had immediate complications (4 biloma, 1 bleeding ,1 bacteremia and 1 perforation), (pZ 0.039). All complications were managed clinically, including the perforation patient. The cost analysis were significantly in favor to metal stent group (pZ0.041). Conclusion: No significant difference was found in regards to procedure time, technical or clinical success. Complications and total costs were significantly higher in the plastic group. Outcomes might be more related to the endoscopist personal experience with one or the other type of stent.
Procedural indications for biliary drainage
Metal Plastic Total
Panc. Cancer
Ext. Compression
Papilla Tumor
Neuroendocrine
GB Tumor
Duodenal Tumor
19 15 34
5 4 9
4 5 9
1 4 5
0 0 0
1 2 3
Total
859 Prospective International Multicenter Study on EUS-Guided Biliary Drainage for Patients With Distal Malignant Biliary Obstruction and Failed ERCP Mouen Khashab*1, Schalk Van Der Merwe2, Rastislav Kunda3, Mohamad H. El Zein1, Anthony Y. Teoh4, Fernando P. Marson5, Carlo Fabbri6, Ilaria Tarantino7, Shyam Varadarajulu8, Rani J. Modayil9, Stavros N. Stavropoulos9, Irene PeñAs10, Saowanee Ngamruengphong1, Vivek Kumbhari1, Joseph Romagnuolo12, Lindsay Hosford11, Manuel Perez-Miranda10, Everson L. Artifon5 1 Johns Hopkins Medical Institute, Baltimore, MD; 2University Hospital KU Leuven, Leuven, Belgium; 3Aarhus University, Aarhus, Denmark; 4 The Chinese University of Hong Kong, Hong Kong, China; 5Ana Costa Hospital, Sao Paulo, Brazil; 6AUSL Bologna Ospedale Bellaria-Maggiore, Bologna, Italy; 7Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Palermo, Italy; 8Florida Hospital, Orlando, FL; 9Winthrop University Hospital, Mineola, NY; 10Hospital Universitario Rio Hortega, Calle Dulzaina, Spain; 11University of Colorado Denver, Denver, CO; 12Medical University of South Carolina, Charleston, SC Background: EUS-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures. However, prospective multicenter data are lacking. Aims: The primary outcome of this prospective study (NCT01889953) was to assess the clinical success of EUS-BD. Secondary outcomes included technical success, rate and severity of adverse events, and long-term outcomes of EUS-BD. Methods: All consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal (R 2cm from the hilum) biliary obstruction and failed ERCP underwent EUS-BD using either rendezvous (REN), direct transluminal (TL) [Choledochoduodenostomy (CDS), Hepatogastrostomy (HGS), Hepatoduodenostomy (HDS)], or antegrade (AG) stenting techniques. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as drop in bilirubin by 50% at 2 weeks or to below 3 (level that allows patients to undergo chemotherapy) at 4 weeks. Adverse events were prospectively tracked and graded according to the ASGE lexicon’s severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier estimate. Results: A total of 95 patients (mean age 66yr, female 44%, pancreatic cancer 55%) underwent EUS-BD [REN 11, AG 12, TL 72 (CDS 53, HGS 15, HDS 4)]. Reason for EUS-BD was obscured ampulla by invasive cancer or enteral stent (nZ49), altered anatomy (nZ9), failed deep biliary cannulation (nZ20), gastric outlet obstruction (nZ17). Electrocautery was used during 66.67% of procedures (coaxial 38.67%, non-coaxial 28%). EUS-guided cholangiography was successful in 94 (99%) patients. Stent placement (technical success) was achieved in 91 (95.7%) patients (metallic stent 83, plastic stent 8). Mean procedure time was 41 minutes (range 8-207). Clinical success was achieved in 85 patients (95%, intention to treat; 89.4%, per protocol analysis). There was significant decrease in bilirubin (mg/dL) at 4 weeks (13.9 vs. 1.86, p!0.0001). A total of 10 (10.5%) adverse events occurred: pneumoperitoneum (nZ2), sheared wire (nZ1), bleeding (nZ1), bile leak (nZ3), cholangitis (nZ2), and perforation (nZ1): 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). There were no predictive factors of clinical success or occurrence of adverse events (all pO0.05). A total of 24 (25%) patients died of disease progression during the study period. The median patient survival was 491 days. The mean stent patency was 536 days (95% CI 383-689) and the one-year stent patency was 61% (Figure 1). Conclusion: This is the first prospective international multicenter study on EUS-BD and demonstrates the excellent
Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB175
Abstracts
efficacy and safety of EUS-BD when performed by experts. Based on these results, a study comparing EUS-BD to percutaneous drainage is being planned.
Figure 1. Kaplan Meier estimate of stent patency
881 Endoscopic Rendezvous Procedure to Treat a Complete Ileorectal Anastomotic Stricture Larissa L. Fujii*1, Faris Murad2 1 Division of Gastroenterology and Hepatology, Washington University, St. Louis, MO; 2Divison of Gastroenterology and Hepatology, Washington University, Washington University, MO Background/Case: A 29 year old female with a history of fistulizing perianal and stricturing ileocolonic Crohn’s disease underwent a total abdominal colectomy with loop ileostomy formation for complications related to her inflammatory bowel disease. Her perianal disease healed with diversion of her fecal contents and her remaining disease was controlled on combination therapy. Prior to her ileostomy takedown, she had a lower GI study which showed a blind-ending pouch that filled to the level of the sutures, but no contrast passed the ileorectal anastomosis. With the surgeon’s approval, the patient was scheduled for an endoscopic rendezvous procedure to treat the complete anastomotic stricture. Endoscopic Methods: After confirming that no opening was visualized from the rectal pouch, the upper endoscope was introduced through the ileostomy to the blind end. To mark the anastomosis site from the ileum, one hemoclip was placed near the presumed anastomosis and contrast was injected to fill the ileal blind limb. The scope was reinserted into the rectum to the anastomosis, and fluoroscopy confirmed that the scope was !1 cm from the contrast in the ileum. Under fluoroscopic guidance, a 19-gauge EUS FNA needle was introduced through the scope and used to localize the area to puncture. The EUS needle was passed into the ileum, followed by a 0.035 inch guidewire. The tract was dilated with the tip of the EUS needle, followed by sequential TTS balloon dilators to a maximum of 12 mm. Finally, three plastic double pigtail stents were placed to keep the tract open. Following the procedure, the patient did well. She underwent two further dilations to a maximum of 18 mm. This adequately opened the anastomosis to allow takedown of her loop ileostomy 5 months later. Clinical Implications: This case highlights an alternative technique for establishing bowel continuity in patients with significant strictures. It was a safe and effective procedure that used standard endoscopic equipment that should be available in any endoscopy unit. The benefit of reestablishing a patent ileorectal anastomosis was that it ultimately allowed the patient to undergo her desired ileostomy takedown.
882 Rendezvous Endoscopic Access and Closure of Large Enterocutaneous Fistula Using Polyglactin Mesh and an Over-the-Scope Clip Shounak Majumder*, Victoria Gomez, Navtej Buttar, Nayantara Coelho Prabhu, Louis M. Wong Kee Song Mayo Clinic, Rochester, MN Background/Case: The management of post-op enterocutaneous (EC) fistulas is challenging. Treatment options are limited and the majority of patients with high
AB176 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
output drainage require repeat surgery, which is associated with significant morbidity and mortality. An 84-year-old woman with complex Crohn’s colitis, statuspost proctocolectomy with end ileostomy, had a post-op course complicated by surgical wound infection and a high output EC fistula interfering with stoma care and resulting in dehydration. She was deemed a poor surgical candidate and was referred for an attempt at endoscopic closure. Endoscopic Methods: A contrast study through the ileostomy showed a tortuous, angulated small bowel pathway to the fistula, and located about 80 cm proximal to the ileostomy. An attempt at reaching the fistula using an upper endoscope and a pediatric colonoscope through the ileostomy was unsuccessful. A rendezvous endoscopic procedure was thus performed in an attempt to access and close the fistula. An upper endoscope, inserted through the ileostomy, was advanced as far as possible toward the fistula. A smallcaliber pediatric endoscope, inserted through the EC fistula, was advanced toward the ileostomy until both endoscopes were in a rendezvous position. Next, a guidewire was passed from the upper endoscope into the pediatric endoscope to exit the fistula site. Both endoscopes were withdrawn, leaving the guidewire in place. Over the guidewire, the upper endoscope fitted with an over-the-scope clip (OTSC) was inserted through the ileostomy and advanced to the fistula site. By keeping the guidewire taut at both ends, the OTSC-loaded endoscope was advanced successfully to the fistula site. Once in position, the guidewire was removed. The rim of the fistula was de-epithelialized using APC. A 2 x 2 in2 folded polyglactin mesh was placed in the fistula tract from the skin side. The mesh-embedded fistula was then closed by deploying the OTSC. Following clip deployment, endoscopic methylene blue instillation showed no visible leakage of the dye externally, consistent with satisfactory fistula closure. At 2-week follow-up, very minimal fistula output was observed. At last follow-up 6 months post-procedure, the fistula site had healed without repeated intervention. Clinical Implications: The rendezvous endoscopic approach may be a potential option for accessing large EC fistulas that are otherwise not reachable by standard endoscopic means, and to enable multimodal therapy, such as fistula tract ablation, mesh placement and clip closure, particularly in patients with comorbidities or an inhospitable abdomen that preclude surgical intervention.
883 Efficacy of Magnetic Marking Clip Method for Pre-Operative Localization of Gastrointestinal Tumor Seung Han Kim*, Bora Keum, in Kyung Yoo, Jae Min Lee, Seung-Joo Nam, Hyuk Soon Choi, Eun Sun Kim, Yoon Tae Jeen, Hongsik Lee, Hoon Jai Chun, Chang Duck Kim, Ja Seol Koo Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (the Republic of) Background/Case: As laparoscopic surgery has been mainly used to resect gastrointestinal (GI) tumors, the importance of tumor localization has been addressed. Without exact tumor localization, resection of unnecessary excess tissue may be happened or surgeons could not secure enough resection margin. Until now, various methods were suggested for the localization of GI tumor in laparoscopic surgery; however there have been several limitations in these methods. This study aimed to assess efficacy and feasibility of a novel method in tumor localization. We enrolled 13 patients with gastric submucosal tumor and 12 patients with early colorectal cancer. Endoscopic Methods: We devised magnetic marking clip (MMC) that was silicon coated 10mm sized ring magnet fixed to endoclip using 3-0 nylon. MMC was applied on the center of lesion during preoperative endoscopy. During surgery, magnetic body which was hanged with long thread which was inserted through laparoscopic trocar, was used tofind tumor lesion which marked by MMC. We analyzed tumor etection rate, detection time, proximal & distal margin from lesion and procedure associated complication. Results: In 13 patients, tumors were located in the stomach and 12 patients in colon. Tumor size ranged from 12 to 18 mm in stomach and 10 to 18 mm in colon. MMC were successfully detected in 25 of 25 patients (100%) in laparoscopic surgery. The time required for detection ranged from 10 to 35 sec in stomach and 20 to 85 sec in colon. The resected margin from lesion ranged from 5 to 30 mm in stomach and 40 to 50mm in colon. None of our patients experienced complications associated with MMC procedure. Clinical implication: MMC method was simple and convenient in tumor localization, and showed excellent outcomes for accuracy of tumor localization and detection rate. Also, there were no procedure associated complications. MMC method could help surgeons to easily localize tumor lesion during laparoscopic surgery.
884 Needle Knife Stricturoplasty of a Benign Colorectal Anastomotic Stricture A. Aziz Aadam*, Shakthi D. Kumar, Jennafer Ottenheimer, Peter J. Sargon Division of Gastroenterology, Rush University Medical Center, Chicago, IL This is a 56 Y male with history of colon cancer. He underwent a sigmoidectomy in 2011 with a loop colostomy. Surgery was complicated by an
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