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Mo1380 Early ERCP Placement of Short Self-Expanding Metal Biliary Stents (SSEMS) in Locally-Advanced Pancreatic Cancer With Biliary Obstruction Improves Success and Outcomes of Neoadjuvant Therapy
Abstracts
clinical difference statistically, newly developed uncovered double bare metallic stent have trend toward longer patency duration compared to conventional uncovered metallic stent. More sample size and follow-up period are required in order to verify these results.
Mo1380 Early ERCP Placement of Short Self-Expanding Metal Biliary Stents (SSEMS) in Locally-Advanced Pancreatic Cancer With Biliary Obstruction Improves Success and Outcomes of Neoadjuvant Therapy Suraj Gupta1, John Walker1, Hani Jarawan1, Lewis B. Richards1, David Klibansky1, Douglas A. Howell*1, Justin Wilkes2, Gina Z. Blaszyk1, Lisa A. Rutstein2 1 Pancreaticobiliary Center, Maine Medical Center, Portland, ME; 2 Surgery, Maine Medical Center, Portland, ME Background: Neoadjuvant therapy (NeoRx) has been increasingly reported for preoperative treatment of pancreatic adenocarcinoma (PANCA). In the subgroup of jaundiced patients (pts) treated with plastic biliary stents, occlusions during NeoRx have led to small series using short self-expanding metal stents (SSEMS) to facilitate NeoRx. We report a large single-center experience using non-foreshortening uncoated SSEMS. Methods: In our center, all pts with biopsy-proven PANCA causing obstructive jaundice regardless of stage undergo ERCP with SSEMS placement or prompt SSEMS replacement of plastic stents. Up-front surgery is recommended for early PANCA (Stage 1a) and palliative chemotherapy for late stages (III & IV). NeoRx of 8 wks of Gemcitabine with 2 wks of XRT is offered to stented pts with locallyadvanced or borderline resectable tumors. Pts are followed for evidence of stent dysfunction, impact on completion of NeoRx, progression of disease, and interference with surgery. All data points are entered into an IRB-approved database. Patients: 89 consecutive stented pts (age 36-87, median 68) accepted NeoRx. Stages were IBZ29, IIAZ38, IIBZ22. After 8 wks of NeoRx and a 4 wk rest, restaging was followed by surgery, if appropriate. Results: 88/89 underwent successful ERCP with 10x40 or 10x60 SSEMS placement without complication. One had post-EUS hemobilia with transient SSEMS occlusion, which cleared before NeoRx began. During 8 wks of chemoRx, 4/89 (4.5%) developed stent dysfunction (recurrent jaundice 3, cholangitis 1). Only 1 missed any chemoRx (less than 5% of total doses). During the rest period 7/89 (7.9%) developed occlusion (jaundice 4, cholangitis 3) treated with ERCP. In addition, one case had stone-related cholecystitis and one had tumor bleeding requiring embolization. The role of the SSEMS was unclear in these two cases. 7/89 (7.9%) did not complete NeoRx (comorbidity 3, toxicity 2, dropout 2). At restaging, 22/82 (26.8%) revealed metastatic disease (nZ19) and progression with vascular encasement (nZ3). 60 cases underwent attempted Whipple resection and 12/60 (20%) proved to be unresectable due to mets or vascular encasement. Resections were successfully performed in 48/60 (80%) of restaged cases or 48/89 (53.9%) of the total study group. Resections were R0Z44, R1Z4, R2Z0. No interference with the line of resection or other surgical complications due to the presence of the SSEMS was recorded. Conclusion: In this large series, early ERCP placement of non-foreshortening uncoated SSEMS permitted NeoRx in all cases without interfering with treatment protocol or surgery. This approach allows pts with occult stage IV or biologically-aggressive cancers to avoid surgery. Reliable SSEMS placement below the line of resection, absence of migration, and avoidance of other early complications appear to be advantages of this approach.
Mo1381 Survival Outcomes and Treatment Failure After Metal Biliary Stent and Open Surgical Biliary Bypass Among Patients With Advanced Pancreatic Adenocarcinoma Receiving Chemotherapy Alessandra Storino*1, Rohan A. Maydeo2, Ammara A. Watkins1, Manuel Castillo-Angeles1, William E. Gooding3, Tara S. Kent1, Mandeep Sawhney2, A. James Moser1 1 Institute of Hepatobiliary & Pancreatic Surgery, Beth Israel Deaconess Medical Center, Boston, MA; 2Advanced Endoscopy and Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA; 3 Biostatistics Department, University of Pittsburgh Cancer Institute, Pittsburgh, PA Background: Recent modeling data indicate that rapid initiation of chemotherapy may improve survival among patients diagnosed with advanced pancreatic ductal adenocarcinoma (PDA). Biliary obstruction, and associated treatment-complications, may delay treatment and diminish survival. We hypothesized that self-expanding metal biliary stents (SEMS) permit earlier initiation of chemotherapy by comparison to open surgical biliary bypass (OSBB) with equivalent patency. Objective: Dual primary endpoints included overall survival and cumulative incidence of treatment failure for biliary obstruction. Methods: Retrospective analysis of 127 subjects with PDA and biliary obstruction diagnosed between 2003-2014. 65 subjects (OSBB) underwent surgical staging and OSBB for unresectable cancer or radiographicallyoccult metastases. 62 subjects received SEMS for locally-advanced disease or radio-
AB400 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
graphically-occult metastases identified during surgical staging. Subjects with radiographically-detectable metastases were excluded. Results: The OSBB and SEMS cohorts did not differ with respect to age, gender, Charlson comorbidity Index, tumor size, or preoperative Ca19-9 (pO0.05). Although NCCN classification demonstrated a higher initial proportion of resectable/borderline lesions in the OSBB (83%) vs. SEMS (45%) groups, the proportion of locally-advanced and occult metastatic PDA in the two cohorts was similar after surgical staging (pZ0.37). Median time to initiation of chemotherapy was earlier in the SEMS (median 12 days, IQR 5-36) than OSBB group (47, IQR 32-63; (pZ0.0033) but had no impact on median overall survival (11 months in both cohorts, pZ0.81). Allocation to stent or surgery was not associated with overall survival (HR: 1.09, 95% CI: .62 - 1.95, pZ.7604). Conversely, median time to treatment failure was 15 months in the SEMS cohort and 29 months after OSBB (pZ0.018, Figure 1) and was significant after adjusting for the cumulative risk of death (pZ0.0055). 24% of subjects required re-intervention after SEMS compared to 8% after OSBB (pZ0.014). The median Comprehensive Complication Index was 0 (0-26.2) after SEMS and 8.7 (0-28.5) after OSBB and (pZ0.1198), corresponding to longer median total hospital stay from intervention to death/loss to follow up after OSBB (median 8 days, IQR 7-11) compared to SEMS (median 1 day, IQR 0-5; p ! .0001). Conclusion: SEMS was associated with faster initiation of chemotherapy and reduced total hospitalization but had no beneficial impact on survival compared to OSBB. OSBB demonstrated longer hospitalization but superior patency that may become clinically-relevant with improving chemotherapy. We conclude that enhanced postoperative recovery after minimally-invasive surgery warrants a prospective randomized clinical trial between SEMS and biliary bypass with the dual endpoints of survival and incidence of treatment failure.
Figure 1. Cumulative Incidence of Treatment Failure
Mo1382 Safety and Efficacy of New Covered Stent With Flared Portion (Flared-Comvi) in Patients With Malignant Gastric Outlet Obstruction Naminatsu Takahara*, Hiroyuki Isayama, Yousuke Nakai, Tsuyoshi Hamada, Dai Mohri, Hirofumi Kogure, Saburo Matsubara, Natsuyo Yamamoto, Minoru Tada, Kazuhiko Koike Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan Background & Aim: Endoscopic placement of self-expandable metal stents (SEMS) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although several reports showed the safety and efficacy of covered and uncovered SEMSs for GOO, both of them have inherent advantages and disadvantages. Generally, covered SEMS can prevent tumor ingrowth which is main cause of occlusion of uncovered SEMS, but have a higher chance to migrate. Frequent migration of covered SEMS may offset its main advantage in preventing tumor ingrowth. Therefore, we developed a new covered SEMS with additional uncovered flare at oral end, Flared-ComVi, to prevent both tumor ingrowth and stent migration. Patients & Methods: Between March and November 2014, 19 patients with symptomatic malignant GOO were managed with Flared-ComVi stents. The primary endpoint was improvement of GOO scoring system (GOOSS) score. Secondary endpoints were technical and clinical success rate, patency, and complications. Results: The study participants consisted of 11 males (58%) with a median age of 68 years. The etiologies of GOO were pancreatic cancer in 7 (37%), gastric cancer in 7(37%), other in 5(26%).The median GOOSS score significantly improved after stenting from 0 to 3 (P ! 0.01). Technical success was achieved in all cases, and clinical success rates were 92%. The median eating period and survival time were 3.1 and 4.6 months,
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clinical difference statistically, newly developed uncovered double bare metallic stent have trend toward longer patency duration compared to conventional uncovered metallic stent. More sample size and follow-up period are required in order to verify these results.
Mo1380 Early ERCP Placement of Short Self-Expanding Metal Biliary Stents (SSEMS) in Locally-Advanced Pancreatic Cancer With Biliary Obstruction Improves Success and Outcomes of Neoadjuvant Therapy Suraj Gupta1, John Walker1, Hani Jarawan1, Lewis B. Richards1, David Klibansky1, Douglas A. Howell*1, Justin Wilkes2, Gina Z. Blaszyk1, Lisa A. Rutstein2 1 Pancreaticobiliary Center, Maine Medical Center, Portland, ME; 2 Surgery, Maine Medical Center, Portland, ME Background: Neoadjuvant therapy (NeoRx) has been increasingly reported for preoperative treatment of pancreatic adenocarcinoma (PANCA). In the subgroup of jaundiced patients (pts) treated with plastic biliary stents, occlusions during NeoRx have led to small series using short self-expanding metal stents (SSEMS) to facilitate NeoRx. We report a large single-center experience using non-foreshortening uncoated SSEMS. Methods: In our center, all pts with biopsy-proven PANCA causing obstructive jaundice regardless of stage undergo ERCP with SSEMS placement or prompt SSEMS replacement of plastic stents. Up-front surgery is recommended for early PANCA (Stage 1a) and palliative chemotherapy for late stages (III & IV). NeoRx of 8 wks of Gemcitabine with 2 wks of XRT is offered to stented pts with locallyadvanced or borderline resectable tumors. Pts are followed for evidence of stent dysfunction, impact on completion of NeoRx, progression of disease, and interference with surgery. All data points are entered into an IRB-approved database. Patients: 89 consecutive stented pts (age 36-87, median 68) accepted NeoRx. Stages were IBZ29, IIAZ38, IIBZ22. After 8 wks of NeoRx and a 4 wk rest, restaging was followed by surgery, if appropriate. Results: 88/89 underwent successful ERCP with 10x40 or 10x60 SSEMS placement without complication. One had post-EUS hemobilia with transient SSEMS occlusion, which cleared before NeoRx began. During 8 wks of chemoRx, 4/89 (4.5%) developed stent dysfunction (recurrent jaundice 3, cholangitis 1). Only 1 missed any chemoRx (less than 5% of total doses). During the rest period 7/89 (7.9%) developed occlusion (jaundice 4, cholangitis 3) treated with ERCP. In addition, one case had stone-related cholecystitis and one had tumor bleeding requiring embolization. The role of the SSEMS was unclear in these two cases. 7/89 (7.9%) did not complete NeoRx (comorbidity 3, toxicity 2, dropout 2). At restaging, 22/82 (26.8%) revealed metastatic disease (nZ19) and progression with vascular encasement (nZ3). 60 cases underwent attempted Whipple resection and 12/60 (20%) proved to be unresectable due to mets or vascular encasement. Resections were successfully performed in 48/60 (80%) of restaged cases or 48/89 (53.9%) of the total study group. Resections were R0Z44, R1Z4, R2Z0. No interference with the line of resection or other surgical complications due to the presence of the SSEMS was recorded. Conclusion: In this large series, early ERCP placement of non-foreshortening uncoated SSEMS permitted NeoRx in all cases without interfering with treatment protocol or surgery. This approach allows pts with occult stage IV or biologically-aggressive cancers to avoid surgery. Reliable SSEMS placement below the line of resection, absence of migration, and avoidance of other early complications appear to be advantages of this approach.
Mo1381 Survival Outcomes and Treatment Failure After Metal Biliary Stent and Open Surgical Biliary Bypass Among Patients With Advanced Pancreatic Adenocarcinoma Receiving Chemotherapy Alessandra Storino*1, Rohan A. Maydeo2, Ammara A. Watkins1, Manuel Castillo-Angeles1, William E. Gooding3, Tara S. Kent1, Mandeep Sawhney2, A. James Moser1 1 Institute of Hepatobiliary & Pancreatic Surgery, Beth Israel Deaconess Medical Center, Boston, MA; 2Advanced Endoscopy and Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA; 3 Biostatistics Department, University of Pittsburgh Cancer Institute, Pittsburgh, PA Background: Recent modeling data indicate that rapid initiation of chemotherapy may improve survival among patients diagnosed with advanced pancreatic ductal adenocarcinoma (PDA). Biliary obstruction, and associated treatment-complications, may delay treatment and diminish survival. We hypothesized that self-expanding metal biliary stents (SEMS) permit earlier initiation of chemotherapy by comparison to open surgical biliary bypass (OSBB) with equivalent patency. Objective: Dual primary endpoints included overall survival and cumulative incidence of treatment failure for biliary obstruction. Methods: Retrospective analysis of 127 subjects with PDA and biliary obstruction diagnosed between 2003-2014. 65 subjects (OSBB) underwent surgical staging and OSBB for unresectable cancer or radiographicallyoccult metastases. 62 subjects received SEMS for locally-advanced disease or radio-
AB400 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
graphically-occult metastases identified during surgical staging. Subjects with radiographically-detectable metastases were excluded. Results: The OSBB and SEMS cohorts did not differ with respect to age, gender, Charlson comorbidity Index, tumor size, or preoperative Ca19-9 (pO0.05). Although NCCN classification demonstrated a higher initial proportion of resectable/borderline lesions in the OSBB (83%) vs. SEMS (45%) groups, the proportion of locally-advanced and occult metastatic PDA in the two cohorts was similar after surgical staging (pZ0.37). Median time to initiation of chemotherapy was earlier in the SEMS (median 12 days, IQR 5-36) than OSBB group (47, IQR 32-63; (pZ0.0033) but had no impact on median overall survival (11 months in both cohorts, pZ0.81). Allocation to stent or surgery was not associated with overall survival (HR: 1.09, 95% CI: .62 - 1.95, pZ.7604). Conversely, median time to treatment failure was 15 months in the SEMS cohort and 29 months after OSBB (pZ0.018, Figure 1) and was significant after adjusting for the cumulative risk of death (pZ0.0055). 24% of subjects required re-intervention after SEMS compared to 8% after OSBB (pZ0.014). The median Comprehensive Complication Index was 0 (0-26.2) after SEMS and 8.7 (0-28.5) after OSBB and (pZ0.1198), corresponding to longer median total hospital stay from intervention to death/loss to follow up after OSBB (median 8 days, IQR 7-11) compared to SEMS (median 1 day, IQR 0-5; p ! .0001). Conclusion: SEMS was associated with faster initiation of chemotherapy and reduced total hospitalization but had no beneficial impact on survival compared to OSBB. OSBB demonstrated longer hospitalization but superior patency that may become clinically-relevant with improving chemotherapy. We conclude that enhanced postoperative recovery after minimally-invasive surgery warrants a prospective randomized clinical trial between SEMS and biliary bypass with the dual endpoints of survival and incidence of treatment failure.
Figure 1. Cumulative Incidence of Treatment Failure
Mo1382 Safety and Efficacy of New Covered Stent With Flared Portion (Flared-Comvi) in Patients With Malignant Gastric Outlet Obstruction Naminatsu Takahara*, Hiroyuki Isayama, Yousuke Nakai, Tsuyoshi Hamada, Dai Mohri, Hirofumi Kogure, Saburo Matsubara, Natsuyo Yamamoto, Minoru Tada, Kazuhiko Koike Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan Background & Aim: Endoscopic placement of self-expandable metal stents (SEMS) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although several reports showed the safety and efficacy of covered and uncovered SEMSs for GOO, both of them have inherent advantages and disadvantages. Generally, covered SEMS can prevent tumor ingrowth which is main cause of occlusion of uncovered SEMS, but have a higher chance to migrate. Frequent migration of covered SEMS may offset its main advantage in preventing tumor ingrowth. Therefore, we developed a new covered SEMS with additional uncovered flare at oral end, Flared-ComVi, to prevent both tumor ingrowth and stent migration. Patients & Methods: Between March and November 2014, 19 patients with symptomatic malignant GOO were managed with Flared-ComVi stents. The primary endpoint was improvement of GOO scoring system (GOOSS) score. Secondary endpoints were technical and clinical success rate, patency, and complications. Results: The study participants consisted of 11 males (58%) with a median age of 68 years. The etiologies of GOO were pancreatic cancer in 7 (37%), gastric cancer in 7(37%), other in 5(26%).The median GOOSS score significantly improved after stenting from 0 to 3 (P ! 0.01). Technical success was achieved in all cases, and clinical success rates were 92%. The median eating period and survival time were 3.1 and 4.6 months,
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