- Email: [email protected]
The feasibility and effectiveness of EUS-guided pancreatic duct drainage
S16
Abstracts / Pancreatology 16 (2016) S1eS192
Results: Patients presented with pseudocyst (n¼8), pancreatic ascites (n¼3) and pleural effusion (n¼3), resulted from acute/chronic pancreatitis (alcoholic; 10, idiopathic; 4). Mean diameter of pseudocyst was 61mm. ERP demonstrated the site of leakage in all patients (head/body/tail; 6/3/5). ENPD/EPS was placed across the disruption in 8 of the 14 patients (57%). Technical and clinical success rate was 100% (14/14) and 93% (13/14), respectively. The median duration of stent placement was 80 (27-134) days. One patient developed proximal stent migration into the pancreatic duct. During median follow up of 12 months, recurrence of pancreatic pseudocyst and pancreatic ascites was observed in each 1 patient (2/13, 15.4%). Conclusions: Endoscopic transpapillary drainage is a technically feasible, safe, and effective treatment modality for patients with pancreatic duct disruption.
performed for the second intervention. In PF, other than conventional procedures were needed. Results: ERCP was succeeded in 6 patients with ARP. Five patients with ARP needed EUS-guided rendezvous method. In 3 patients among 5 patients with PF, the anastomosis was occluded, and EUS-guided or percutaneus pancreatojejunostomy was performed. In 2 patients with PF suffering within 3 months, PF was treated by placing a percutaneus catheter through the ruptured anastomosis. All symptomatic SPAs were cured. Complications were limited to mild pancreatitis. Conclusions: ERCP is the first for treatment of SPA. Identification of the anastomosis is responsible for accomplishment of ERCP. For the second intervention in patients with failed ERCP, EUS-guided rendezvous method is feasible for ARP. In patients with PF, the anastomosis usually occluded, and making another pancreatojejunostomy is needed by comprehensive endoscopic procedures with percutaneus methods.
S1-3. Clinical features of acute obstructive suppurative pancreatic ductitis: A retrospective review of 20 cases
S1-5.
Hiromu Kondo 1, Itaru Naitoh 1, Kazuki Hayashi 1, Tesshin Ban 1, Katsuyuki Miyabe 1, Yuji Nishi 1, Michihiro Yoshida 1, Shuichiro Umemura 1, Yasuki Hori 1, Makoto Natsume 1, Akihisa Kato 1, Hirotaka Ohara 2, Takashi Joh 1
Short-type single-balloon enteroscopy-assisted ERCP in patients with pancreaticojejunal anastomotic stricture following pancreaticoduodenectomy
1 Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Japan 2 Department of Community-based Medical Education, Nagoya City University Graduate School of Medical Sciences, Japan
Kazumasa Nagai, Kei Lane, Akio Katanuma, Kuniyuki Takahashi, Toshifumi Kin, Satoshi Ikarashi, Itsuki Sano, Hajime Yamazaki, Koh Kitagawa, Kensuke Yokoyama, Hideaki Koga, Hiroyuki Maguchi
Background and aims: The clinical features of acute obstructive suppurative pancreatic ductitis (AOSPD) have not been elucidated. We aimed to clarify the clinical features of AOSPD. Methods: We retrospectively reviewed the clinical features of 20 patients with AOSPD at two tertiary referral centers between 1993 and 2012. We compared 17 AOSPD patients with chronic pancreatitis (CP) and 42 patients with acute-on-CP in terms of clinical characteristics, presentation, and laboratory and imaging findings. Results: The etiology of AOSPD involved CP in 17 (85%) patients. Endoscopic pancreatic drainage was effective in 19 (95%) patients. Body temperature was significantly higher in AOSPD with CP than acute-on-CP patients (median: 38.2 vs. 36.9 C; p <0.001). Serum amylase at onset was significantly lower (median: 133 vs. 364.5 U/L; p¼0.009), and C-reactive protein was significantly higher (median: 9.42 vs. 1.06 mg/dL; p <0.001) in AOSPD with CP patients. Enlargement of the pancreatic parenchyma (18% vs. 93%; p <0.001) and stranding of the surrounding fat (12% vs. 93%; p <0.001) on computed tomography were observed less frequently in patients with AOSPD with CP patients. The diameter of the main pancreatic duct was significantly greater in AOSPD with CP than acute-on-CP patients (median: 7 vs. 5 mm; p¼0.006). Conclusions: The major etiology of AOSPD involved CP, and endoscopic pancreatic drainage was effective. The clinical features differ between AOSPD with CP and acute-on-CP.
S1-4. Experiments and strategy for treatment of stenotic pancreatodigestive anastomosis after pancreatoduodenectomy
Center for Gastroenterology, Teine Keijinkai Hospital, Japan Objective: This study evaluated the usefulness of short-type singleballoon enteroscopy (short-SBE) -assisted ERCP for the treatment of patients with pancreaticojejunal (PJ) anastomotic stricture following pancreaticoduodenectomy (PD). Patients and methods: A total of 14 patients [4 men, 10 women; median age 57 years (range 28-86 years)] with PJ anastomotic stricture following PD underwent short-SBE-assisted ERCP (SBE-ERCP) between July 2011 and January 2016. The procedures were performed using a prototype short-type single-balloon enteroscope with a 3.2 mm working channel, a 9.2 mm diameter, and a 152 cm working length. Technical success was defined as completion of pancreatography and anastomotic dilation. Clinical success was described as improvements of symptoms, laboratory data, and image findings. Procedure time was indicated as the time from scope insertion to scope withdrawal. Results: Short-SBE enabled the afferent blind ends in all of the patients to be reached. Technical success was achieved in 5 of the 14 patients (36%) on the first attempt. Of the 9 remaining patients, SBE-ERCP was reattempted in 3 patients, of whom technical success was obtained in 2 patients. Therefore, the overall technical success rate of SBE-ERCP was 50% (7/ 14). Clinical success was achieved in all of the 7 patients with technical success. The median procedural time for the 7 successful cases was 49 minutes (range, 23-96 minutes). There were no post-procedural adverse events. For all the other 7 patients who failed the procedure, their PJ anastomosis had not been identified. These patients were managed by surgery (n¼2), endoscopic ultrasound-guided rendezvous (n¼1), and conservative therapy (n¼4) . Conclusions: SBE-ERCP was an effective, less invasive, and safe treatment for patients with PJ anastomotic stricture following PD and in whom pancreatic duct cannulation was successful. Further improvements to accurately identify the PJ anastomosis are needed to enhance technical success.
Masataka Kikuyama Gastroenterolgy, Shizuoka Genearal Hospital, Japan Background: Stricture of pancreatodigestive anastomosis (SPA) is experienced after pancreatoduodenectomy (PD). SPA induces acute recurrent pancreatitis (ARP), and is associated with pancreatic fistula (PF). Drainage of the pancreatic duct contributes to relief of these complications. Methods: Sixteen patients with symptomatic SPA (ARP/PF¼11/5) were treated. ERCP is the first to be selected to place a stent across the strictured anastomosis. If ERCP was failed, EUS-guided rendezvous method was
S1-6. The feasibility and effectiveness of EUS-guided pancreatic duct drainage Hironari Kato, Sho Mizukawa, Shuntaro Yabe, Hiroyuki Seki, Daisuke Uchida, Yutaka Akimoto, Takeshi Tomoda, Kazuyuki Matsumoto, Naoki Yamamoto, Shigeru Horiguchi, Koichiro Tsutsumi, Hiroyuki Okada Okayama University Hospital, Japan
Abstracts / Pancreatology 16 (2016) S1eS192
Aim: We analyzed the results of EUS-guided pancreatic duct drainage (EUS-PD) in our institution. Method: Twelve patients (10 males, mean age 65 years) undergoing EUS-PD were retrospectively analyzed. Evaluation items were patient characteristics, technical success, clinical success, and complications. Results: The reasons for EUS-PD were chronic pancreatitis (n¼4), postoperative complication (n¼3), and obstructive pancreatitis due to unresectable malignant tumor (n¼5). Of 12 patients, 10 failed ERCP, and remaining two failed double-balloon ERCP before EUS-PD. Ten of 12 patients (83%) achieved successful deployment of plastic stents. Remaining two patients who had pancreatic fluid collection after pancreaticojejunostomy failed Rendezvous methods by EUS-PD route. However, these two patients did not receive stent deployment, because they had received percutaneous drainage for fluid collection before EUS-PD. All 10 patients with successful stent deployment achieved clinical resolution. Complications occurred in five patients (42%). Bleeding occurred in two patients requiring IVR. Stent migration occurred in remaining three patients. All five patients with malignant obstructive pancreatitis achieved both technical and clinical success, and no stent dysfunction occurred during follow-up period (median 147 days (range: 18-414)). Conclusion: EUS-PD is feasible and effective especially in patients with malignant obstructive pancreatitis as a palliative therapy.
S1-7. Predictors of pain response in patients undergoing EUS-guided neurolysis for abdominal pain caused by pancreatic cancer Kosuke Minaga, Masayuki Kitano, Masatoshi Kudo Department of Gastroenterology and Hepatology, Kinki University, Japan Background and objectives: Interventional endoscopic ultrasound (EUS) -guided procedures such as EUS-guided celiac ganglia neurolysis (EUS-CGN) and EUS-guided broad plexus neurolysis (EUS-BPN) were developed to treat abdominal cancer-associated pain; however, these procedures are not always effective. The aim of the present study was to ascertain predictors of pain response in EUS-guided neurolysis for pancreatic cancer-associated pain. Patients and methods: This was a retrospective analysis of prospectively collected data of 112 consecutive patients who underwent EUS-BPN in our institution. EUS-CGN was added in cases of visible celiac ganglia. The neurolytic spread area was divided into six areas and evaluated by postprocedural computed tomography scanning. Pain intensity was assessed using a visual analog scale (VAS), and a decrease in VAS scores by 3 points after neurolysis was considered a good pain response. Univariable and multivariable logistic regression analyses were performed to explore predictors of pain response at 1 and 4 weeks and complications. Results: A good pain response was obtained in 77.7% and 67.9% of patients at 1 and 4 weeks, respectively. In the multivariable analysis of these patients, the combination method (EUS-BPN plus CGN) was a significant positive predictive factor at 1 week (odds ratio¼3.69, P¼0.017) and 4 weeks (odds ratio¼6.37, P¼0.043). The numbers of neurolytic/contrast spread areas (mean±SD) were 4.98±1.08 and 4.15±1.12 in patients treated with the combination method and single method, respectively (P <0.001). There was no significant predictor of complications. Conclusions: EUS-BPN in combination with EUS-CGN was a predictor of a good pain response in EUS-guided neurolysis for pancreatic cancerrelated pain. The larger number of neurolytic/contrast spread areas may lead to better outcomes in patients receiving combination treatment.
S1-8. Phase 1 dose-escalation clinical trial of EUS-guided injection of HF10 for unresectable locally advanced pancreatic cancer Yoshiki Hirooka 1, Hiroki Kawashima 2, Eizaburo Ohno 2, Hideki Kasuya 3, Maki Tanaka 4, Hidemi Goto 2
S17
1
Department of Endoscopy, Nagoya University Hospital, Japan Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Japan 3 Department of Surgery 2, Nagoya University Graduate School of Medicine, Japan 4 Gene Medicine Business Unit, Takara Bio Inc., Japan 2
Background/aim: HF10 is a spontaneous mutant of herpes simplex virus Type 1 (HSV-1) that replicates within tumors and destroys cancer cells without damaging normal organs. We conducted the phase 1 doseescalation trial of HF10 direct injection into unresectable locally advanced pancreatic cancer under EUS-guidance in combination with Erlotinib and Gemcitabine administration. Patients and methods: This study was a single arm, open-label Phase 1 trial. All patients were diagnosed as pancreatic cancer histopathologically and as unresectable. Following 1 course of Chemotherapy, those judged tolerable for next course were final candidates. The number of HF-10 injection was to be 4 times in total (once every two weeks) and this therapy continued till the appearance of DLT. Three Cohorts, total 9 subjects were planned to enroll in this trial [Cohort 1 (1106 pfu/day4 times): 3 subjects, Cohort 2 (3106 pfu/ day4times): 3 subjects, Cohort 3 (1107 pfu/day4times) 3 subjects]. This study was registered in UMIN-CTR (UMIN000010150) and was approved by the Ethical Committee in our institute. Result: Of 12 patients, 10 subjects including 1 dropout subject received this therapy. Six of 10 subjects showed myelosuppression (Grade III) caused by chemotherapy. Two of 10 subjects developed serious adverse events (AEs), and these were judged as AEs unrelated to HF10. Regarding tumor suppression effect, overall responses were 3 PRs, 4 SDs, and 2 PDs out of 9 subjects who completed the treatment. Target lesion responses were 3 PRs, 6 SDs out of 9 subjects. Effective response of target lesion (PR + SD) was 100%. Two subjects from Cohort 1 and 2 showed down staging and reevaluated to resectable cancer, then received surgical CR finally. Conclusion: HF10 direct injection therapy for unresectable locally advanced pancreatic cancer under EUS-guidance in combination with Erlotinib and Gemcitabine administration was safe and effective.
S2-KL. Lesson from chemoradiotherapy followed by surgery for borderline and locally advanced pancreatic cancer (BRPC and LAPC) Sun-Whe Kim Department of Surgery, Seoul National University Hospital, South Korea Proportion of BRPC and LAPC was over 30% (BRPC: 7.4%; LAPC: 23.4%) of total pancreatic cancer cases (N¼1,716) who visited SNUH during recent 8 years. Among the BRPC 126 cases, surgery was performed in 68 cases (53.9%) either as upfront surgery (35.7%) or after chemo-radiotherapy (18.2%). All the surgical cases including cases that were initially defined BRPC or LAPC during the last 6 years were reviewed. Some of the BRPC cases were enrolled in the multicenter RCT study to compare upfront surgery and neo-adjuvant therapy followed by surgery. The RCT was hold because the interim analysis demonstrated that upfront surgery has shown definitively worse outcome. Forty two patients underwent adjuvant therapy (gemcitabine or FORFIRINOX based) before surgery (BRPC: N¼29, LAPC: N¼13). Tumor response to preoperative treatment was stable disease (SD) in most cases and partial remission was observed in 25%. Resection was performed in 35 cases (76.1% of surgery cases). R0 rate was 77% (27/35). Postoperative morbidity was not so different from resectable cases, but pancreatic fistula rate was lower. Preoperative therapy tends to decrease number of retrieved lymph node and positive lymph node. Although margin positivity is higher, survival rate was comparable to resectable cases, once curative surgery was performed. Although FORFIRINOX group showed better tumor response before surgery, survival outcome did not reach statistically significant difference. Even though only a limited number of patients would undergo resection, CRT should be tried first for LAPC and BRPC. Because CT interpretation has limited reliability, BRPC after CRT including cases down-staged from LAPC should be explored by surgery. Perivascular findings on CT seem to be not always consistent with
Abstracts / Pancreatology 16 (2016) S1eS192
Results: Patients presented with pseudocyst (n¼8), pancreatic ascites (n¼3) and pleural effusion (n¼3), resulted from acute/chronic pancreatitis (alcoholic; 10, idiopathic; 4). Mean diameter of pseudocyst was 61mm. ERP demonstrated the site of leakage in all patients (head/body/tail; 6/3/5). ENPD/EPS was placed across the disruption in 8 of the 14 patients (57%). Technical and clinical success rate was 100% (14/14) and 93% (13/14), respectively. The median duration of stent placement was 80 (27-134) days. One patient developed proximal stent migration into the pancreatic duct. During median follow up of 12 months, recurrence of pancreatic pseudocyst and pancreatic ascites was observed in each 1 patient (2/13, 15.4%). Conclusions: Endoscopic transpapillary drainage is a technically feasible, safe, and effective treatment modality for patients with pancreatic duct disruption.
performed for the second intervention. In PF, other than conventional procedures were needed. Results: ERCP was succeeded in 6 patients with ARP. Five patients with ARP needed EUS-guided rendezvous method. In 3 patients among 5 patients with PF, the anastomosis was occluded, and EUS-guided or percutaneus pancreatojejunostomy was performed. In 2 patients with PF suffering within 3 months, PF was treated by placing a percutaneus catheter through the ruptured anastomosis. All symptomatic SPAs were cured. Complications were limited to mild pancreatitis. Conclusions: ERCP is the first for treatment of SPA. Identification of the anastomosis is responsible for accomplishment of ERCP. For the second intervention in patients with failed ERCP, EUS-guided rendezvous method is feasible for ARP. In patients with PF, the anastomosis usually occluded, and making another pancreatojejunostomy is needed by comprehensive endoscopic procedures with percutaneus methods.
S1-3. Clinical features of acute obstructive suppurative pancreatic ductitis: A retrospective review of 20 cases
S1-5.
Hiromu Kondo 1, Itaru Naitoh 1, Kazuki Hayashi 1, Tesshin Ban 1, Katsuyuki Miyabe 1, Yuji Nishi 1, Michihiro Yoshida 1, Shuichiro Umemura 1, Yasuki Hori 1, Makoto Natsume 1, Akihisa Kato 1, Hirotaka Ohara 2, Takashi Joh 1
Short-type single-balloon enteroscopy-assisted ERCP in patients with pancreaticojejunal anastomotic stricture following pancreaticoduodenectomy
1 Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Japan 2 Department of Community-based Medical Education, Nagoya City University Graduate School of Medical Sciences, Japan
Kazumasa Nagai, Kei Lane, Akio Katanuma, Kuniyuki Takahashi, Toshifumi Kin, Satoshi Ikarashi, Itsuki Sano, Hajime Yamazaki, Koh Kitagawa, Kensuke Yokoyama, Hideaki Koga, Hiroyuki Maguchi
Background and aims: The clinical features of acute obstructive suppurative pancreatic ductitis (AOSPD) have not been elucidated. We aimed to clarify the clinical features of AOSPD. Methods: We retrospectively reviewed the clinical features of 20 patients with AOSPD at two tertiary referral centers between 1993 and 2012. We compared 17 AOSPD patients with chronic pancreatitis (CP) and 42 patients with acute-on-CP in terms of clinical characteristics, presentation, and laboratory and imaging findings. Results: The etiology of AOSPD involved CP in 17 (85%) patients. Endoscopic pancreatic drainage was effective in 19 (95%) patients. Body temperature was significantly higher in AOSPD with CP than acute-on-CP patients (median: 38.2 vs. 36.9 C; p <0.001). Serum amylase at onset was significantly lower (median: 133 vs. 364.5 U/L; p¼0.009), and C-reactive protein was significantly higher (median: 9.42 vs. 1.06 mg/dL; p <0.001) in AOSPD with CP patients. Enlargement of the pancreatic parenchyma (18% vs. 93%; p <0.001) and stranding of the surrounding fat (12% vs. 93%; p <0.001) on computed tomography were observed less frequently in patients with AOSPD with CP patients. The diameter of the main pancreatic duct was significantly greater in AOSPD with CP than acute-on-CP patients (median: 7 vs. 5 mm; p¼0.006). Conclusions: The major etiology of AOSPD involved CP, and endoscopic pancreatic drainage was effective. The clinical features differ between AOSPD with CP and acute-on-CP.
S1-4. Experiments and strategy for treatment of stenotic pancreatodigestive anastomosis after pancreatoduodenectomy
Center for Gastroenterology, Teine Keijinkai Hospital, Japan Objective: This study evaluated the usefulness of short-type singleballoon enteroscopy (short-SBE) -assisted ERCP for the treatment of patients with pancreaticojejunal (PJ) anastomotic stricture following pancreaticoduodenectomy (PD). Patients and methods: A total of 14 patients [4 men, 10 women; median age 57 years (range 28-86 years)] with PJ anastomotic stricture following PD underwent short-SBE-assisted ERCP (SBE-ERCP) between July 2011 and January 2016. The procedures were performed using a prototype short-type single-balloon enteroscope with a 3.2 mm working channel, a 9.2 mm diameter, and a 152 cm working length. Technical success was defined as completion of pancreatography and anastomotic dilation. Clinical success was described as improvements of symptoms, laboratory data, and image findings. Procedure time was indicated as the time from scope insertion to scope withdrawal. Results: Short-SBE enabled the afferent blind ends in all of the patients to be reached. Technical success was achieved in 5 of the 14 patients (36%) on the first attempt. Of the 9 remaining patients, SBE-ERCP was reattempted in 3 patients, of whom technical success was obtained in 2 patients. Therefore, the overall technical success rate of SBE-ERCP was 50% (7/ 14). Clinical success was achieved in all of the 7 patients with technical success. The median procedural time for the 7 successful cases was 49 minutes (range, 23-96 minutes). There were no post-procedural adverse events. For all the other 7 patients who failed the procedure, their PJ anastomosis had not been identified. These patients were managed by surgery (n¼2), endoscopic ultrasound-guided rendezvous (n¼1), and conservative therapy (n¼4) . Conclusions: SBE-ERCP was an effective, less invasive, and safe treatment for patients with PJ anastomotic stricture following PD and in whom pancreatic duct cannulation was successful. Further improvements to accurately identify the PJ anastomosis are needed to enhance technical success.
Masataka Kikuyama Gastroenterolgy, Shizuoka Genearal Hospital, Japan Background: Stricture of pancreatodigestive anastomosis (SPA) is experienced after pancreatoduodenectomy (PD). SPA induces acute recurrent pancreatitis (ARP), and is associated with pancreatic fistula (PF). Drainage of the pancreatic duct contributes to relief of these complications. Methods: Sixteen patients with symptomatic SPA (ARP/PF¼11/5) were treated. ERCP is the first to be selected to place a stent across the strictured anastomosis. If ERCP was failed, EUS-guided rendezvous method was
S1-6. The feasibility and effectiveness of EUS-guided pancreatic duct drainage Hironari Kato, Sho Mizukawa, Shuntaro Yabe, Hiroyuki Seki, Daisuke Uchida, Yutaka Akimoto, Takeshi Tomoda, Kazuyuki Matsumoto, Naoki Yamamoto, Shigeru Horiguchi, Koichiro Tsutsumi, Hiroyuki Okada Okayama University Hospital, Japan
Abstracts / Pancreatology 16 (2016) S1eS192
Aim: We analyzed the results of EUS-guided pancreatic duct drainage (EUS-PD) in our institution. Method: Twelve patients (10 males, mean age 65 years) undergoing EUS-PD were retrospectively analyzed. Evaluation items were patient characteristics, technical success, clinical success, and complications. Results: The reasons for EUS-PD were chronic pancreatitis (n¼4), postoperative complication (n¼3), and obstructive pancreatitis due to unresectable malignant tumor (n¼5). Of 12 patients, 10 failed ERCP, and remaining two failed double-balloon ERCP before EUS-PD. Ten of 12 patients (83%) achieved successful deployment of plastic stents. Remaining two patients who had pancreatic fluid collection after pancreaticojejunostomy failed Rendezvous methods by EUS-PD route. However, these two patients did not receive stent deployment, because they had received percutaneous drainage for fluid collection before EUS-PD. All 10 patients with successful stent deployment achieved clinical resolution. Complications occurred in five patients (42%). Bleeding occurred in two patients requiring IVR. Stent migration occurred in remaining three patients. All five patients with malignant obstructive pancreatitis achieved both technical and clinical success, and no stent dysfunction occurred during follow-up period (median 147 days (range: 18-414)). Conclusion: EUS-PD is feasible and effective especially in patients with malignant obstructive pancreatitis as a palliative therapy.
S1-7. Predictors of pain response in patients undergoing EUS-guided neurolysis for abdominal pain caused by pancreatic cancer Kosuke Minaga, Masayuki Kitano, Masatoshi Kudo Department of Gastroenterology and Hepatology, Kinki University, Japan Background and objectives: Interventional endoscopic ultrasound (EUS) -guided procedures such as EUS-guided celiac ganglia neurolysis (EUS-CGN) and EUS-guided broad plexus neurolysis (EUS-BPN) were developed to treat abdominal cancer-associated pain; however, these procedures are not always effective. The aim of the present study was to ascertain predictors of pain response in EUS-guided neurolysis for pancreatic cancer-associated pain. Patients and methods: This was a retrospective analysis of prospectively collected data of 112 consecutive patients who underwent EUS-BPN in our institution. EUS-CGN was added in cases of visible celiac ganglia. The neurolytic spread area was divided into six areas and evaluated by postprocedural computed tomography scanning. Pain intensity was assessed using a visual analog scale (VAS), and a decrease in VAS scores by 3 points after neurolysis was considered a good pain response. Univariable and multivariable logistic regression analyses were performed to explore predictors of pain response at 1 and 4 weeks and complications. Results: A good pain response was obtained in 77.7% and 67.9% of patients at 1 and 4 weeks, respectively. In the multivariable analysis of these patients, the combination method (EUS-BPN plus CGN) was a significant positive predictive factor at 1 week (odds ratio¼3.69, P¼0.017) and 4 weeks (odds ratio¼6.37, P¼0.043). The numbers of neurolytic/contrast spread areas (mean±SD) were 4.98±1.08 and 4.15±1.12 in patients treated with the combination method and single method, respectively (P <0.001). There was no significant predictor of complications. Conclusions: EUS-BPN in combination with EUS-CGN was a predictor of a good pain response in EUS-guided neurolysis for pancreatic cancerrelated pain. The larger number of neurolytic/contrast spread areas may lead to better outcomes in patients receiving combination treatment.
S1-8. Phase 1 dose-escalation clinical trial of EUS-guided injection of HF10 for unresectable locally advanced pancreatic cancer Yoshiki Hirooka 1, Hiroki Kawashima 2, Eizaburo Ohno 2, Hideki Kasuya 3, Maki Tanaka 4, Hidemi Goto 2
S17
1
Department of Endoscopy, Nagoya University Hospital, Japan Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Japan 3 Department of Surgery 2, Nagoya University Graduate School of Medicine, Japan 4 Gene Medicine Business Unit, Takara Bio Inc., Japan 2
Background/aim: HF10 is a spontaneous mutant of herpes simplex virus Type 1 (HSV-1) that replicates within tumors and destroys cancer cells without damaging normal organs. We conducted the phase 1 doseescalation trial of HF10 direct injection into unresectable locally advanced pancreatic cancer under EUS-guidance in combination with Erlotinib and Gemcitabine administration. Patients and methods: This study was a single arm, open-label Phase 1 trial. All patients were diagnosed as pancreatic cancer histopathologically and as unresectable. Following 1 course of Chemotherapy, those judged tolerable for next course were final candidates. The number of HF-10 injection was to be 4 times in total (once every two weeks) and this therapy continued till the appearance of DLT. Three Cohorts, total 9 subjects were planned to enroll in this trial [Cohort 1 (1106 pfu/day4 times): 3 subjects, Cohort 2 (3106 pfu/ day4times): 3 subjects, Cohort 3 (1107 pfu/day4times) 3 subjects]. This study was registered in UMIN-CTR (UMIN000010150) and was approved by the Ethical Committee in our institute. Result: Of 12 patients, 10 subjects including 1 dropout subject received this therapy. Six of 10 subjects showed myelosuppression (Grade III) caused by chemotherapy. Two of 10 subjects developed serious adverse events (AEs), and these were judged as AEs unrelated to HF10. Regarding tumor suppression effect, overall responses were 3 PRs, 4 SDs, and 2 PDs out of 9 subjects who completed the treatment. Target lesion responses were 3 PRs, 6 SDs out of 9 subjects. Effective response of target lesion (PR + SD) was 100%. Two subjects from Cohort 1 and 2 showed down staging and reevaluated to resectable cancer, then received surgical CR finally. Conclusion: HF10 direct injection therapy for unresectable locally advanced pancreatic cancer under EUS-guidance in combination with Erlotinib and Gemcitabine administration was safe and effective.
S2-KL. Lesson from chemoradiotherapy followed by surgery for borderline and locally advanced pancreatic cancer (BRPC and LAPC) Sun-Whe Kim Department of Surgery, Seoul National University Hospital, South Korea Proportion of BRPC and LAPC was over 30% (BRPC: 7.4%; LAPC: 23.4%) of total pancreatic cancer cases (N¼1,716) who visited SNUH during recent 8 years. Among the BRPC 126 cases, surgery was performed in 68 cases (53.9%) either as upfront surgery (35.7%) or after chemo-radiotherapy (18.2%). All the surgical cases including cases that were initially defined BRPC or LAPC during the last 6 years were reviewed. Some of the BRPC cases were enrolled in the multicenter RCT study to compare upfront surgery and neo-adjuvant therapy followed by surgery. The RCT was hold because the interim analysis demonstrated that upfront surgery has shown definitively worse outcome. Forty two patients underwent adjuvant therapy (gemcitabine or FORFIRINOX based) before surgery (BRPC: N¼29, LAPC: N¼13). Tumor response to preoperative treatment was stable disease (SD) in most cases and partial remission was observed in 25%. Resection was performed in 35 cases (76.1% of surgery cases). R0 rate was 77% (27/35). Postoperative morbidity was not so different from resectable cases, but pancreatic fistula rate was lower. Preoperative therapy tends to decrease number of retrieved lymph node and positive lymph node. Although margin positivity is higher, survival rate was comparable to resectable cases, once curative surgery was performed. Although FORFIRINOX group showed better tumor response before surgery, survival outcome did not reach statistically significant difference. Even though only a limited number of patients would undergo resection, CRT should be tried first for LAPC and BRPC. Because CT interpretation has limited reliability, BRPC after CRT including cases down-staged from LAPC should be explored by surgery. Perivascular findings on CT seem to be not always consistent with