- Email: [email protected]
Tu1409 Early ERCP Is Associated With Lower Mortality in Patients With Acute Cholangitis
Abstracts
Tu1407 Randomized Trial of Cholangioscopy-Guided Laser Lithotripsy vs. Conventional Endoscopic Therapy for Large Bile Duct Stones James L. Buxbaum*1, Christopher Ko1, Chung Yao Yu1, Preeth Jayaram1, Terrence Lee1, Suraj Patel1, Ara Sahakian1, Linda A. Hou1, Daniel S. Shue1, Loren Laine2 1 Medicine/Gastroenterology, University of Southern California, Los Angeles, CA; 2Gastroenterology, Yale University, New Haven, CT Background: Common bile duct (CBD) stones >1cm have a decreased incidence of successful endoscopic extraction and often require lithotripsy. While prior guidelines suggested mechanical lithotripsy for large CBD stones, current guidelines suggest cholangioscopy-guided lithotripsy as an adjunct with or without balloon dilation or mechanical lithotripsy. However, no randomized trials have assessed the utility of this practice. Methods: Patients with CBD stones >1cm in diameter were randomized in a 2:1 ratio with concealed allocation to cholangioscopy-guided holmium laser lithotripsy vs. conventional therapy only. Cholangioscopy was performed using a single-operator through-the-scope system. In order to simulate current practice and guideline recommendations, conventional therapies such as mechanical lithotripsy or balloon dilation were allowed in the laser lithotripsy group. Randomization was stratified by history of prior ERCP. The primary outcome was endoscopic clearance of bile duct stones. Additional outcomes were procedure time, fluoroscopy time, and number of procedures required for attempted or successful stone removal. Safety outcomes included complications of post-ERCP pancreatitis, cholangitis, and bleeding. Results: Characteristics of the 59 patients assigned to the two groups were similar (Table 1). Endoscopic clearance was achieved in 38/41 (92%) with cholangioscopy-guided laser lithotripsy and 12/18 (67%) by conventional therapy only (pZ0.018). The nine patients (3 laser, 6 conventional) in whom ERCP was unsuccessful underwent surgical common duct exploration with stone removal. Mean procedure time was 118 (+48.3) minutes for the cholangioscopy-guided laser lithotripsy group compared to 81.2 (+39.1) minutes for the conventional therapy group (pZ0.022). There was no significant difference in fluoroscopy time, number of procedures, or complications between the two treatment arms (Table 2). Complications included cholangitis (laser-1, conventional-1) and post-ERCP pancreatitis (laser-2, conventional-1). Cholangitis led to fatal sepsis in 1 patient in the conventional methods group. In the laser therapy group cholangioscopy-guided laser lithotripsy was used as the primary treatment modality in all patients; mechanical lithotripsy and/or papillary dilation was also used in 25 (61%) patients. In the conventional therapy group, balloon extraction alone was successful in 3 patients, while mechanical lithotripsy and/or papillary dilation was used in the remaining 15 (83%) patients. Conclusion: Cholangioscopy-guided laser lithotripsy increases the incidence of endoscopic clearance of large bile duct stones and decreases the need for surgery as compared to conventional therapy alone. However, it is associated with longer procedure times. ClinicalTrials.gov Identifier NCT0175997
Selected Characteristics of the Study Groups Conventional Only (N[18)
Cholangioscopy-Guided laser Therapy (N[41) N(%)
Female Gender Hispanic Ethnicity Multiple Stones Comorbidities
12 (67) 14 (78) 12 (67) 7 (50)
Age (Years)
42.6 (14.5)
Total Stone Volume (cm3) Total Bilirubin (mg/dL) Alkaline Phosphatase (mg/dL)
3.2 (4.4) 1.9 (2.4) 217 (109)
28 (68) 31 (76) 24 (59) 23 (56) Mean (Standard Deviation) 51.6 (13.4) Median (Interquartile Range) 3.3 (4.5) 1.5 (2.1) 184 (234)
Outcomes in the Study Groups Conventional Only (N[18)
Cholangioscopy-Guided Laser (N[41) N(%)
Endoscopic Stone Clearance Complications Procedure Time (Minutes) Number of ERCPs as part of Study Fluoroscopy Time (Minutes)
12 (67) 2 (11)
38 (92)* 3 (7) Mean (Standard Deviation) 81.2 (49.3) 118.8 (39.0)* Median (Interquartile Range) 2 (1) 2 (1) 11 (8.4) 9.1 (7.7)
Tu1408 A Comparison of Unilateral Versus Bilateral Endoscopic Biliary Stenting for Bismuth-Corlette II-IV Malignant Hilar Strictures Sile Cheng, Jianfeng yang, Xiaofeng Zhang* Hangzhou first people’ hospital, Hangzhou, China Background and Aims: Whether unilateral or bilateral endoscopic biliary stenting is superior to treat malignant hilar strictures is controversial. We compared the 2 procedures by evaluating drainage success and early complications in patients with Bismuth-Corlette II-IV malignant hilar strictures. Methods: We recruited 180 consecutive patients treated between June 2010 and June 2014; 163 were ultimately included in this study. Patients were randomly divided into the unilateral (A) or bilateral (B) endoscopic drainage groups after endoscopic retrograde cholangiopancreatography. All patients were followed for up to 1 month, and successful drainage and presence of early complications were evaluated. Results: Eighty patients underwent unilateral stenting (group A) while 83 received bilateral stents (group B). There were no significant differences in patient demographics between the 2 groups. Successful drainage was achieved in 53 patients (66.3%) of group A and 60 patients (72.3%) of group B with no significant difference between the groups (pZ0.497). Sub-analysis according to the Bismuth-Corlette stratification showed that both groups A and B achieved a similar drainage success rate. The most common complications appearing in both groups were acute cholangitis, which occurred in 23 patients (28.8%) of group A and 39 patients (47.0%) in group B; the difference was significant (pZ0.024). There were no significant differences in elevated amylase, acute pancreatitis, and bleeding and stent occlusion between the 2 groups. Conclusions: Unilateral biliary stent placement in patients with malignant biliary obstructions is as effective as bilateral stent placement, and can reduce rates of early complications, particularly acute cholangitis.
Tu1409 Early ERCP Is Associated With Lower Mortality in Patients With Acute Cholangitis Ming Tan*, Ove B. Schaffalitzky de Muckadell, Stig B. Laursen Department of Medical Gastroenterology S, Odense University Hospital, Odense, Funen, Denmark Introduction: Acute cholangitis (AC) is associated with high mortality of up to 10% and frequent complications including organ failure. Although previous studies have shown that early endoscopic retrograde cholangiopancreatography (ERCP) may be associated with better outcomes (e.g. lower incidence of organ failure and reduced length of hospital stay), no association has been found between timing of ERCP and mortality. Aims and methods: The aim of this study was to investigate if early ERCP in AC patients was associated with improved survival. All AC patients that underwent ERCP at the Department of Medical Gastroenterology, Odense University Hospital, Denmark, between March 2009 and September 2016 were identified using a prospective ERCP database. Clinical data were collected from medical records. Patients fulfilling both the Tokyo Guidelines 2013 criteria, and a detailed review of medical records for evidence of AC, were included. We hypothesized that ERCP within 24 hours from hospital admission was associated with lower 30-day mortality. We investigated the association between ERCP within 24 hours and 30-day mortality using logistic regression analysis with adjustment for confounding factors. Results: In total, 3797 patients underwent ERCP during the period of inclusion. Out of these, 163 patients fulfilled the criteria for diagnosis of AC. Forty-eight patients (29%) underwent ERCP within 24 hours from the time of hospitalization and 115 patients (71%) underwent later ERCP. Baseline characteristics of the study population are shown in Table 1. Patients undergoing ERCP within 24 hours were younger (pZ0.007; medians: 65 versus 73) and had a higher heart rate (pZ0.010; medians: 95 versus 90 beats/min), as compared to patients who underwent later ERCP. Overall 30-day mortality was 17%. Mortality was 8% among patients undergoing early ERCP, and 20% among patients undergoing ERCP later than 24 hours from time of hospital admission (pZ0.077). Performance of ERCP within 24 hours was associated with lower 30-day mortality (OR [95% CI]: 0.22 [0.05-0.98]; pZ0.046), when adjusting for: American Society of Anesthesiology physical classification (ASA) score (OR [95% CI]: 11.61 [4.04-33.33]; p<0.001), leukocytosis (white blood cell count >12 x 10E9/L; OR [95% CI]: 3.94 [1.25-12.43]; pZ0.019) and hyperbilirubinemia (Bilirubin >100 mmol/L; OR [95% CI]: 3.24 [1.07-9.84]; pZ0.038). Age was not associated with mortality (OR [95% CI]: 1.013 [0.98-1.05]; pZ0.51), when included in the regression model. Conclusion: Our results indicate that, when adjusting for prognostic factors, early ERCP is associated with lower 30-day mortality in patients with AC.
*p
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Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB613
Abstracts Table 1 – Baseline characteristics and outcome
Patient characteristics: Age, years, Median Male gender American Society of Anesthesiology physical classification (ASA) score, Mean Vital parameters: Body temperature, C, Median Systolic blood pressure, mmHg, Median Heart rate, /min., Median Laboratory values at hospital admission: White blood cell count, x 10E9/L, Median Bilirubin, mmol/L, Median Alkaline phosphatase, U/L, Median C-reactive protein, mg/L, Median Systemic inflammatory response syndrome (SIRS) Acute cholangitis presentation: Bacteremia Malignant obstruction etiology 30-day mortality
ERCP (n [ 48)
ERCP ≥24 hours group (n [ 115)
p-value
71
65
73
0.01
89 (55%) 2.7
25 (52%) 2.7
64 (56%) 2.8
0.68 0.53
37.6
38.1
37.5
0.05
126
122
127
0.50
92
95
90
0.01
13
12.95
13
0.77
74
78
72
0.70
419
368
439
0.93
96
100
94
0.39
100/150 (67%)
31/45 (69%)
69/105 (66%)
0.71
76/135 (56%) 70 (43%) 27 (17%)
22/38 (58%) 15 (31%) 4 (8%)
54/97 (56%) 55 (48%) 23 (20%)
0.82 0.06 0.08
All patients (n [ 163)
and biliary stricture (distal vs mid/proximal CBD). Median overall survival was significantly longer in patients with chemo/XRT (17 months), compared to untreated patient (5 months) and one treatment (10 months) based on log-rank test (P<0.001). Conclusion: Chemoradiotherapy has significantly lower risk of all-cause recurrent biliary obstruction following metal stent placement and improved overall survival. Future studies on adverse events are warranted to aid in the choice of covered or uncovered biliary stents.
Data are n (%) unless otherwise stated.
Tu1410 Does Chemoradiation Prevent Recurrent Biliary Obstruction Following Metal Biliary Stent Placement? Tomas DaVee*1, Matthew T. Glover2,1, Keshav Kukreja3,1, Graciela M. Nogueras-González4, Brian R. Weston1, William Ross1, Gottumukkala S. Raju1, Phillip Lum1, Jeffrey Lee1 1 Gastroenterology, The University of Texas - MD Anderson Cancer Center, Houston, TX; 2Internal Medicine, Baylor College of Medicine, Houston, TX; 3Internal Medicine, The University of Texas Health Science Center at Houston, Houston, TX; 4Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX Background: Covered and uncovered self-expandable metal biliary stents (CSEMS and USEMS, respectively) offer durable palliation of malignant biliary obstructions. Data regarding all-cause recurrent biliary obstruction (RBO; i.e. due to tumor growth, new strictures, migration, stones, food debris, etc.) are limited. The objective of this study was estimate the risk of all-cause RBO with metal biliary stents and chemoradiation. Methods: Adults with malignant biliary obstruction who underwent ERCP for initial metal biliary stent placement between 2001 and 2016 were retrospectively identified. Patients with preexisting plastic stents undergoing metal stent exchange were included. Patients with obstructions within 2 cm of the bifurcation and/or intrahepatic ducts, or with known liver metastasis were excluded. Recurrent biliary obstruction (RBO) was defined by worsening abnormal liver tests (i.e. serum bilirubin increase to greater than 3 mg/dL in the absence of other plausible etiology) with or without biliary dilation on imaging, and/or cholangitis (fever with jaundice or fever with elevated liver tests). Results: 1022 patients were included. Median age was 65, 56% were male, and pancreatic cancers were in 80%. CSEMS were placed in 18% and USEMS 82%. RBO was diagnosed in 24%, of which 61% (152/250) were due to tumor ingrowth/overgrowth. Chemo/XRT was given in 47%; with 30% receiving chemotherapy only and 1% radiation therapy only. Overall, there is a significant lower risk of all-cause RBO in patients with chemo/XRT 12% (28) compared to patients who received neither 26% (125) and compared to patients who received only one treatment modality 31% (97); P<0.001. Patients with chemo/XRT had lower risk of tumor ingrowth/overgrowth as a cause of RBO (7% [16] vs patients without 14% [66] vs patients who received only one treatment modality 23% [70]; P<0.001). The incidence of all-cause RBO was similar between CSEMS and USEMS (19% [35] vs 26% [215]; PZ0.077). In a multivariate model, the association between chemo/XRT and all-cause RBO remained significant (OR Z 0.38, 95% CI: 0.24-0.60) compared to untreated patients when controlling for age, gender, pancreatic cancer, stent type
AB614 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017
Tu1411 Photodynamic Therapy in Unresectable Cholangiocarcinoma: Long Term International Experience of 12 Years Michel Kahaleh*1, Anthony Y. Teoh6, Uzma Siddiqui5, Virendra Joshi4, Michael D. Saunders3, Monica Saumoy1, Monica Gaidhane1, Amy Tyberg1, Reem Z. Sharaiha1, David E. Loren2 1 Weill Cornell Medical Center, New York, NY; 2Gastroenterology, Thomas Jefferson University Hospital, Philedelphia, PA; 3Gastroenterology, Washington University, Seattle, WA; 4Gastroenterology, Ochsner Medical Center, New Orleans, LA; 5Gastroenterology, University of Chicago, Chicago, IL; 6Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong Background: Photodynamic therapy (PDT) with or without combination chemotherapy/radiation has been reported to improve survival in unresectable cholangiocarcinoma cases. We are reporting our long-term follow-up data from 7 US and International tertiary care centers for survival duration probability. Methods: Patients who underwent PDT for unresectable cholangiocarcinoma between 2004 and 2016 were included in a dedicated registry. Photofrin (porfirmer sodium) 2 mg/kg body weight was administered intravenously 48 hours prior to PDT. PDT was delivered through a cylindrical diffuser and photoactivation was performed at 630 nm with a light dose of 180 J/cm2, fluence of 0.250 W/cm2 and irradiation time of 750 seconds. Cholangioscopy guidance was used at the discretion of the endoscopist. Stents were placed after PDT to prevent cholangitis. PDT sessions were conducted every 3-4 months. Demographics, medical history, procedure specifics, adverse events and survival duration were collected. Results: 126 patients were included (57%M, mean age 66 years). 64 patients (51%) had Bismuth type IV, 50 (40%) had Bismuth type III, and 12 (10 %) had Bismuth type I and II. 13% patients had metastasis. 94% patients had stents placed prior to PDT. Mean number of PDT sessions was 2 (Range 1 – 9). Plastic stents post PDT were placed in 121 patients (96%). 62 patients (49%) received either or both chemotherapy and radiation. Total strictures treated was 232 (mean 2) with majority of them being in the hilum (88%). Adverse events included phototoxicity (22), cholangitis (42), cholecystitis (3), jaundice (6), pancreatitis (2), hemobilia (3), hepatic abscess (7), peritonitis (2), gallbladder perforation (1), and sepsis (1). 97/118 patients died from progression of disease; there were no procedure related deaths. Mean survival duration was 391.6 days (range 12- 2065). Cox proportional-hazards regression and Kaplan-Meier analysis was performed comparing the group of patients who received PDT and chemotherapy/radiation therapy vs. those who received PDT only. After controlling for Bismuth classification, stricture location, and cholangioscopy-directed treatment, there was no significant difference in the survival means of both groups (p value Z 0.8380). Conclusion: PDT has a measurable impact on survival in unresectable cholangiocarcinoma regardless of whether adjuvant chemotherapy or radiation is administered.
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Tu1407 Randomized Trial of Cholangioscopy-Guided Laser Lithotripsy vs. Conventional Endoscopic Therapy for Large Bile Duct Stones James L. Buxbaum*1, Christopher Ko1, Chung Yao Yu1, Preeth Jayaram1, Terrence Lee1, Suraj Patel1, Ara Sahakian1, Linda A. Hou1, Daniel S. Shue1, Loren Laine2 1 Medicine/Gastroenterology, University of Southern California, Los Angeles, CA; 2Gastroenterology, Yale University, New Haven, CT Background: Common bile duct (CBD) stones >1cm have a decreased incidence of successful endoscopic extraction and often require lithotripsy. While prior guidelines suggested mechanical lithotripsy for large CBD stones, current guidelines suggest cholangioscopy-guided lithotripsy as an adjunct with or without balloon dilation or mechanical lithotripsy. However, no randomized trials have assessed the utility of this practice. Methods: Patients with CBD stones >1cm in diameter were randomized in a 2:1 ratio with concealed allocation to cholangioscopy-guided holmium laser lithotripsy vs. conventional therapy only. Cholangioscopy was performed using a single-operator through-the-scope system. In order to simulate current practice and guideline recommendations, conventional therapies such as mechanical lithotripsy or balloon dilation were allowed in the laser lithotripsy group. Randomization was stratified by history of prior ERCP. The primary outcome was endoscopic clearance of bile duct stones. Additional outcomes were procedure time, fluoroscopy time, and number of procedures required for attempted or successful stone removal. Safety outcomes included complications of post-ERCP pancreatitis, cholangitis, and bleeding. Results: Characteristics of the 59 patients assigned to the two groups were similar (Table 1). Endoscopic clearance was achieved in 38/41 (92%) with cholangioscopy-guided laser lithotripsy and 12/18 (67%) by conventional therapy only (pZ0.018). The nine patients (3 laser, 6 conventional) in whom ERCP was unsuccessful underwent surgical common duct exploration with stone removal. Mean procedure time was 118 (+48.3) minutes for the cholangioscopy-guided laser lithotripsy group compared to 81.2 (+39.1) minutes for the conventional therapy group (pZ0.022). There was no significant difference in fluoroscopy time, number of procedures, or complications between the two treatment arms (Table 2). Complications included cholangitis (laser-1, conventional-1) and post-ERCP pancreatitis (laser-2, conventional-1). Cholangitis led to fatal sepsis in 1 patient in the conventional methods group. In the laser therapy group cholangioscopy-guided laser lithotripsy was used as the primary treatment modality in all patients; mechanical lithotripsy and/or papillary dilation was also used in 25 (61%) patients. In the conventional therapy group, balloon extraction alone was successful in 3 patients, while mechanical lithotripsy and/or papillary dilation was used in the remaining 15 (83%) patients. Conclusion: Cholangioscopy-guided laser lithotripsy increases the incidence of endoscopic clearance of large bile duct stones and decreases the need for surgery as compared to conventional therapy alone. However, it is associated with longer procedure times. ClinicalTrials.gov Identifier NCT0175997
Selected Characteristics of the Study Groups Conventional Only (N[18)
Cholangioscopy-Guided laser Therapy (N[41) N(%)
Female Gender Hispanic Ethnicity Multiple Stones Comorbidities
12 (67) 14 (78) 12 (67) 7 (50)
Age (Years)
42.6 (14.5)
Total Stone Volume (cm3) Total Bilirubin (mg/dL) Alkaline Phosphatase (mg/dL)
3.2 (4.4) 1.9 (2.4) 217 (109)
28 (68) 31 (76) 24 (59) 23 (56) Mean (Standard Deviation) 51.6 (13.4) Median (Interquartile Range) 3.3 (4.5) 1.5 (2.1) 184 (234)
Outcomes in the Study Groups Conventional Only (N[18)
Cholangioscopy-Guided Laser (N[41) N(%)
Endoscopic Stone Clearance Complications Procedure Time (Minutes) Number of ERCPs as part of Study Fluoroscopy Time (Minutes)
12 (67) 2 (11)
38 (92)* 3 (7) Mean (Standard Deviation) 81.2 (49.3) 118.8 (39.0)* Median (Interquartile Range) 2 (1) 2 (1) 11 (8.4) 9.1 (7.7)
Tu1408 A Comparison of Unilateral Versus Bilateral Endoscopic Biliary Stenting for Bismuth-Corlette II-IV Malignant Hilar Strictures Sile Cheng, Jianfeng yang, Xiaofeng Zhang* Hangzhou first people’ hospital, Hangzhou, China Background and Aims: Whether unilateral or bilateral endoscopic biliary stenting is superior to treat malignant hilar strictures is controversial. We compared the 2 procedures by evaluating drainage success and early complications in patients with Bismuth-Corlette II-IV malignant hilar strictures. Methods: We recruited 180 consecutive patients treated between June 2010 and June 2014; 163 were ultimately included in this study. Patients were randomly divided into the unilateral (A) or bilateral (B) endoscopic drainage groups after endoscopic retrograde cholangiopancreatography. All patients were followed for up to 1 month, and successful drainage and presence of early complications were evaluated. Results: Eighty patients underwent unilateral stenting (group A) while 83 received bilateral stents (group B). There were no significant differences in patient demographics between the 2 groups. Successful drainage was achieved in 53 patients (66.3%) of group A and 60 patients (72.3%) of group B with no significant difference between the groups (pZ0.497). Sub-analysis according to the Bismuth-Corlette stratification showed that both groups A and B achieved a similar drainage success rate. The most common complications appearing in both groups were acute cholangitis, which occurred in 23 patients (28.8%) of group A and 39 patients (47.0%) in group B; the difference was significant (pZ0.024). There were no significant differences in elevated amylase, acute pancreatitis, and bleeding and stent occlusion between the 2 groups. Conclusions: Unilateral biliary stent placement in patients with malignant biliary obstructions is as effective as bilateral stent placement, and can reduce rates of early complications, particularly acute cholangitis.
Tu1409 Early ERCP Is Associated With Lower Mortality in Patients With Acute Cholangitis Ming Tan*, Ove B. Schaffalitzky de Muckadell, Stig B. Laursen Department of Medical Gastroenterology S, Odense University Hospital, Odense, Funen, Denmark Introduction: Acute cholangitis (AC) is associated with high mortality of up to 10% and frequent complications including organ failure. Although previous studies have shown that early endoscopic retrograde cholangiopancreatography (ERCP) may be associated with better outcomes (e.g. lower incidence of organ failure and reduced length of hospital stay), no association has been found between timing of ERCP and mortality. Aims and methods: The aim of this study was to investigate if early ERCP in AC patients was associated with improved survival. All AC patients that underwent ERCP at the Department of Medical Gastroenterology, Odense University Hospital, Denmark, between March 2009 and September 2016 were identified using a prospective ERCP database. Clinical data were collected from medical records. Patients fulfilling both the Tokyo Guidelines 2013 criteria, and a detailed review of medical records for evidence of AC, were included. We hypothesized that ERCP within 24 hours from hospital admission was associated with lower 30-day mortality. We investigated the association between ERCP within 24 hours and 30-day mortality using logistic regression analysis with adjustment for confounding factors. Results: In total, 3797 patients underwent ERCP during the period of inclusion. Out of these, 163 patients fulfilled the criteria for diagnosis of AC. Forty-eight patients (29%) underwent ERCP within 24 hours from the time of hospitalization and 115 patients (71%) underwent later ERCP. Baseline characteristics of the study population are shown in Table 1. Patients undergoing ERCP within 24 hours were younger (pZ0.007; medians: 65 versus 73) and had a higher heart rate (pZ0.010; medians: 95 versus 90 beats/min), as compared to patients who underwent later ERCP. Overall 30-day mortality was 17%. Mortality was 8% among patients undergoing early ERCP, and 20% among patients undergoing ERCP later than 24 hours from time of hospital admission (pZ0.077). Performance of ERCP within 24 hours was associated with lower 30-day mortality (OR [95% CI]: 0.22 [0.05-0.98]; pZ0.046), when adjusting for: American Society of Anesthesiology physical classification (ASA) score (OR [95% CI]: 11.61 [4.04-33.33]; p<0.001), leukocytosis (white blood cell count >12 x 10E9/L; OR [95% CI]: 3.94 [1.25-12.43]; pZ0.019) and hyperbilirubinemia (Bilirubin >100 mmol/L; OR [95% CI]: 3.24 [1.07-9.84]; pZ0.038). Age was not associated with mortality (OR [95% CI]: 1.013 [0.98-1.05]; pZ0.51), when included in the regression model. Conclusion: Our results indicate that, when adjusting for prognostic factors, early ERCP is associated with lower 30-day mortality in patients with AC.
*p
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Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB613
Abstracts Table 1 – Baseline characteristics and outcome
Patient characteristics: Age, years, Median Male gender American Society of Anesthesiology physical classification (ASA) score, Mean Vital parameters: Body temperature, C, Median Systolic blood pressure, mmHg, Median Heart rate, /min., Median Laboratory values at hospital admission: White blood cell count, x 10E9/L, Median Bilirubin, mmol/L, Median Alkaline phosphatase, U/L, Median C-reactive protein, mg/L, Median Systemic inflammatory response syndrome (SIRS) Acute cholangitis presentation: Bacteremia Malignant obstruction etiology 30-day mortality
ERCP (n [ 48)
ERCP ≥24 hours group (n [ 115)
p-value
71
65
73
0.01
89 (55%) 2.7
25 (52%) 2.7
64 (56%) 2.8
0.68 0.53
37.6
38.1
37.5
0.05
126
122
127
0.50
92
95
90
0.01
13
12.95
13
0.77
74
78
72
0.70
419
368
439
0.93
96
100
94
0.39
100/150 (67%)
31/45 (69%)
69/105 (66%)
0.71
76/135 (56%) 70 (43%) 27 (17%)
22/38 (58%) 15 (31%) 4 (8%)
54/97 (56%) 55 (48%) 23 (20%)
0.82 0.06 0.08
All patients (n [ 163)
and biliary stricture (distal vs mid/proximal CBD). Median overall survival was significantly longer in patients with chemo/XRT (17 months), compared to untreated patient (5 months) and one treatment (10 months) based on log-rank test (P<0.001). Conclusion: Chemoradiotherapy has significantly lower risk of all-cause recurrent biliary obstruction following metal stent placement and improved overall survival. Future studies on adverse events are warranted to aid in the choice of covered or uncovered biliary stents.
Data are n (%) unless otherwise stated.
Tu1410 Does Chemoradiation Prevent Recurrent Biliary Obstruction Following Metal Biliary Stent Placement? Tomas DaVee*1, Matthew T. Glover2,1, Keshav Kukreja3,1, Graciela M. Nogueras-González4, Brian R. Weston1, William Ross1, Gottumukkala S. Raju1, Phillip Lum1, Jeffrey Lee1 1 Gastroenterology, The University of Texas - MD Anderson Cancer Center, Houston, TX; 2Internal Medicine, Baylor College of Medicine, Houston, TX; 3Internal Medicine, The University of Texas Health Science Center at Houston, Houston, TX; 4Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX Background: Covered and uncovered self-expandable metal biliary stents (CSEMS and USEMS, respectively) offer durable palliation of malignant biliary obstructions. Data regarding all-cause recurrent biliary obstruction (RBO; i.e. due to tumor growth, new strictures, migration, stones, food debris, etc.) are limited. The objective of this study was estimate the risk of all-cause RBO with metal biliary stents and chemoradiation. Methods: Adults with malignant biliary obstruction who underwent ERCP for initial metal biliary stent placement between 2001 and 2016 were retrospectively identified. Patients with preexisting plastic stents undergoing metal stent exchange were included. Patients with obstructions within 2 cm of the bifurcation and/or intrahepatic ducts, or with known liver metastasis were excluded. Recurrent biliary obstruction (RBO) was defined by worsening abnormal liver tests (i.e. serum bilirubin increase to greater than 3 mg/dL in the absence of other plausible etiology) with or without biliary dilation on imaging, and/or cholangitis (fever with jaundice or fever with elevated liver tests). Results: 1022 patients were included. Median age was 65, 56% were male, and pancreatic cancers were in 80%. CSEMS were placed in 18% and USEMS 82%. RBO was diagnosed in 24%, of which 61% (152/250) were due to tumor ingrowth/overgrowth. Chemo/XRT was given in 47%; with 30% receiving chemotherapy only and 1% radiation therapy only. Overall, there is a significant lower risk of all-cause RBO in patients with chemo/XRT 12% (28) compared to patients who received neither 26% (125) and compared to patients who received only one treatment modality 31% (97); P<0.001. Patients with chemo/XRT had lower risk of tumor ingrowth/overgrowth as a cause of RBO (7% [16] vs patients without 14% [66] vs patients who received only one treatment modality 23% [70]; P<0.001). The incidence of all-cause RBO was similar between CSEMS and USEMS (19% [35] vs 26% [215]; PZ0.077). In a multivariate model, the association between chemo/XRT and all-cause RBO remained significant (OR Z 0.38, 95% CI: 0.24-0.60) compared to untreated patients when controlling for age, gender, pancreatic cancer, stent type
AB614 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017
Tu1411 Photodynamic Therapy in Unresectable Cholangiocarcinoma: Long Term International Experience of 12 Years Michel Kahaleh*1, Anthony Y. Teoh6, Uzma Siddiqui5, Virendra Joshi4, Michael D. Saunders3, Monica Saumoy1, Monica Gaidhane1, Amy Tyberg1, Reem Z. Sharaiha1, David E. Loren2 1 Weill Cornell Medical Center, New York, NY; 2Gastroenterology, Thomas Jefferson University Hospital, Philedelphia, PA; 3Gastroenterology, Washington University, Seattle, WA; 4Gastroenterology, Ochsner Medical Center, New Orleans, LA; 5Gastroenterology, University of Chicago, Chicago, IL; 6Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong Background: Photodynamic therapy (PDT) with or without combination chemotherapy/radiation has been reported to improve survival in unresectable cholangiocarcinoma cases. We are reporting our long-term follow-up data from 7 US and International tertiary care centers for survival duration probability. Methods: Patients who underwent PDT for unresectable cholangiocarcinoma between 2004 and 2016 were included in a dedicated registry. Photofrin (porfirmer sodium) 2 mg/kg body weight was administered intravenously 48 hours prior to PDT. PDT was delivered through a cylindrical diffuser and photoactivation was performed at 630 nm with a light dose of 180 J/cm2, fluence of 0.250 W/cm2 and irradiation time of 750 seconds. Cholangioscopy guidance was used at the discretion of the endoscopist. Stents were placed after PDT to prevent cholangitis. PDT sessions were conducted every 3-4 months. Demographics, medical history, procedure specifics, adverse events and survival duration were collected. Results: 126 patients were included (57%M, mean age 66 years). 64 patients (51%) had Bismuth type IV, 50 (40%) had Bismuth type III, and 12 (10 %) had Bismuth type I and II. 13% patients had metastasis. 94% patients had stents placed prior to PDT. Mean number of PDT sessions was 2 (Range 1 – 9). Plastic stents post PDT were placed in 121 patients (96%). 62 patients (49%) received either or both chemotherapy and radiation. Total strictures treated was 232 (mean 2) with majority of them being in the hilum (88%). Adverse events included phototoxicity (22), cholangitis (42), cholecystitis (3), jaundice (6), pancreatitis (2), hemobilia (3), hepatic abscess (7), peritonitis (2), gallbladder perforation (1), and sepsis (1). 97/118 patients died from progression of disease; there were no procedure related deaths. Mean survival duration was 391.6 days (range 12- 2065). Cox proportional-hazards regression and Kaplan-Meier analysis was performed comparing the group of patients who received PDT and chemotherapy/radiation therapy vs. those who received PDT only. After controlling for Bismuth classification, stricture location, and cholangioscopy-directed treatment, there was no significant difference in the survival means of both groups (p value Z 0.8380). Conclusion: PDT has a measurable impact on survival in unresectable cholangiocarcinoma regardless of whether adjuvant chemotherapy or radiation is administered.
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