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Adding Balloon Sphincteroplasty to Sphincterotomy in Endoscopic Removal of Large Bile Duct Stones - A Randomized Controlled Trial
Abstracts
613 Adding Balloon Sphincteroplasty to Sphincterotomy in Endoscopic Removal of Large Bile Duct Stones - A Randomized Controlled Trial Frances K. Cheung, Bing Hu, Ya MIN Pan, Yu BAO Zhou, Philip W. Chiu, Enders K. NG, Justin Wu, Francis K L. Chan, Joseph J. Sung, James Y. Lau Background: in patients with large bile duct stones, we hypothesize that the added use of balloon sphincteroplasty after endoscopic sphincterotomy may facilitate stone removal without increasing procedure related complications. Methods: Patients with suspected bile duct stones provided consent to trial participation prior to endoscopy. Those with bile duct stones in O13mm bile duct on cholangiogram were randomized to undergo sphincterotomy (ES) or sphincterotomy plus balloon dilatation (ES-BD) using CRE balloon up to 15mm (Boston Scientific) Patients with previous sphincterotomy who required extension to sphincterotomy were also included. Stones were retrieved using Dormia baskets, balloons or mechanical lithotripsy or their combinations. We excluded patients who required pre-cut sphincterotomy for access and those with cirrhosis or coagulopathy. Our primary outcome measure was the rate of complete bile duct clearance during first endoscopy. Secondary outcome measures included time for stone clearance, the use of mechanical lithotripsy and procedure related complications. Results: 86 patients were recruited from April 2005 to October 2008. Two patients were excluded due to violation of protocol (1 using precut as access and one received wrong assigned treatment). There were 42 patients in ES and 42 patients in ESBD group. Their ages, ASA grade, indication for ERCP, use of NSAID or aspirin, presence of peri-ampullary diverticulum were similar. The mean bile duct size was comparable (ES 16.5þ/-6.3 mm, ESBD 15.8þ/-4.5 mm). The mean stone size was similar (ES 10.9 þ/- 5.2 mm, ESBD 12.6 þ/- 4.7 mm; pZ0.12). The rate of stone clearance rate for ES and ESBD were 92% and 88% respectively (pZ0.71). The stone clearance time was 25 þ/- 13 mins and 28 þ/- 13 mins for ES and ESBD respectively (pZ0.28). Mechanical lithotripsy was required in 36% in ES group and 26% in ESBD group (pZ0.35). Complication rate was similar. 4 patients in ES group and 3 in ESBD group suffered from complications (1 mild pancreatitis, 2 severe sepsis, and 1 moderate sepsis in ES group; 1 hemorrhage of moderate severity, 1 mild pancreatitis and 1 mild sepsis in ESBD group). There was no mortality. Conclusion: Endoscopic balloon dilatation after sphincterotomy offer similar efficacy of stone retrieval and similar complication rate when compared with sphincterotomy alone in patients with dilated bile duct and large bile duct stones.
614 Intraductal Ultrasonography Can Discriminate Between Sclerosing Cholangitis Associated with Autoimmune Pancreatitis and Primary Sclerosing Cholangitis Kensuke Kubota, Shingo Kato, Noritoshi Kobayashi, Atsushi Nakajima Background: Intraductal ultrasonography (IDUS) produces high quality cross sectional images that are useful for the characterization of biliary structures affected with sclerosing cholangitis, however, the differentiation between sclerosing cholangitis associated with autoimmune pancreatitis (SC-AIP) and primary sclerosing cholangitis (PSC) has been challenging. No report has appeared to clarify the clinical significance of IDUS findings when making therapeutic decisions such as corticosteroid therapy in SC-AIP patients. Aim: To evaluate the characteristic IDUS features, which could potentially discriminate PSC patients from patients with SC-AIP. Methods: Nine AIP patients and 8 patients with PSC who had undergone IDUS followed by ERCP between April 2004 and November 2008 were identified from our database. IDUS was performed with a 20 MHz over the guidewire probe (UM-G20-29R: Olympus, Tokyo, Japan).IDUS images taken from hilar part of the bile duct and duodenal papilla in AIP and PSC patients were studied. We reviewed the following IDUS features of the bile duct as being potentially related to the differentiation of PSC cases from those with SC-AIP, such as the presence of symmetric thickness, wall thickness, the presence of a heterogenous internal echo and the presence of lateral mucosal lesions continuous to the hilar. Results: The outcomes of IDUS (SC-AIP vs PSC) were as follows: the presence of symmetrical thickness, 89% (8/9) vs: 25% (2/8); wall thickness (mm), 3.0 1.0 vs 2.1 0.7; the presence of a heterogeneous internal echo, 66.7% (6/9) vs 22.2% (2/9); and the presence of lateral mucosal lesions continuous to the hilar, 55.6% (5/9) vs 11.1% (1/9). Symmetrical thickness of the bile duct, a heterogeneous internal echo and the presence of lateral mucosal lesions continuous to the hilar were significantly more detected in cases of SC-PSC than PSC (p!0.05). The wall thickness tended to be prominent in SC-AIP cases than that of the PSC cases. No complication associated with IDUS occurred during or after the procedures. Conclusions: Our results suggest that IDUS findings such as symmetric thickness, wall thickness, the presence of a heterogenous internal echo and lateral mucosal lesions continuous to the hilar enhanced the differential diagnosis between SC-AIP and PSC. These findings support the routine use of endoscopic cholangiographic images in all patients with indeterminate sclerosing cholangitis.
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615 Video Cholangiopancreatoscopy (CP) with Narrow Band Imaging (NBI): Spectrum of Mucosal and Vascular Patterns in Patients with Pancreaticobiliary (PB) Pathology Raj J. Shah, Yang K. Chen Background: Clinical experience w/ CP-NBI is limited and there is no standard terminology for CP findings. The goals of the study are: 1) to determine if new CP equipped w/ NBI and improved optical resolution enhances CP findings and diagnosis (DX); 2) to provide descriptive terminology of CP-NBI findings across a full spectrum of PB diseases. Methods: Ongoing prospective study of pts undergoing CPNBI w/ Olympus CHF-Y0002 (3.4mm OD, 1.2mm channel, 70 up/down deflection, 90 FOV) and prototype duodenoscope. CP videos were reviewed by 2 MDs (RS, YC; 17 yr cumulative CP experience) to reach consensus on interpretation of white light (WL)/NBI findings for vessels, mucosa, and benign (BEN) or malignant (MAL) DX. CP findings: 1) discrete lesions - ulceration (ULC), polypoid/vegetative mass (MASS), infiltrative stricture (INFL), nodules (NDL), low (LPP) or finger-like papillary projections (FPP); 2) other mucosal findings e.g. atrophy (ATR), pseudodiverticulae (TIC) and 3) WL and NBI vascular patterns [none, minimal, or prominent; fine reticular capillary pattern (FRP) or tortuous/dilated ‘‘tumor’’ vessels (TDV)]. Results: 20 pts (mean 59yr, 14M) were enrolled from 9/08 to 11/08; 1pt was excluded from analysis for failure to traverse stricture with CP. Indications: indeterminate biliary stricture (NZ6), PSC dominant stricture (NZ6), suspected choledochal cyst (CC) (NZ4) or IPMN (NZ2), and extent of cholangioCA (CCA) (NZ1). Pts had mean of 2.5 (0-12) prior tissue sampling events. 7 (37%) had MAL DX based on CP visualization or tissue sampling; 5/7 (71%) had TDV. NBI enhanced imaging of TDV in 2 pts and detected TDV missed by WL in 1 pt; 2/7 pts with no TDV had MASS (NZ1), and INFL and FPP (NZ1). Mucosal characteristics in pts with MAL: INFL (NZ5), ULC (NZ3), FPP (NZ2), MASS (NZ1), LPP (NZ1), and NDL (NZ1). The following features seen in MAL are also seen in BEN: ULC (NZ3), LPP (NZ3, all w/ indwelling stents), and NDL (NZ3). Most common mucosal finding was TIC (NZ11 pts; 7 BEN, 4 MAL). Follow-up is ongoing but preliminary Dx: BEN PSC (NZ6), CCA (NZ6), CC (NZ3), IPMN (NZ1) and other (NZ3). CP findings in PSC: band-like scarring (NZ5), TIC (NZ3), ULC (NZ2), NDL (NZ2), and ATR (NZ1). In suspected CC: LPP (NZ2), TIC (NZ2), ATR (NZ2), ULC (NZ1), and prominent vs. minimal FRP by NBI vs. WL (NZ1). Conclusions: 1. Video CP enhances detection of ‘‘tumor vessels’’ 2. TIC is likely from cholestasis seen in both BEN and MAL diseases. 3. Band-like scarring is a BEN feature. 4. LPP may be stent-induced or seen with IPMN and CC. 5. This is the 1st report of CP-NBI findings in PSC and CC. 6. Long-term follow-up is planned to determine predictive value of video CP-NBI findings.
616 Endoscopic Hemostasis with High-Frequency Soft Coagulation for Bleeding Gastric Ulcer: Comparison with Metallic Hemoclips in a Prospective, Randomized Study Seiichiro Arima, Shinichi Ogata, Naoyuki Tominaga, Nanae Tsuruoka, Kotaro Mannen, Yasuhisa Sakata, Ryo Shimoda, Seiji Tsunada, Hiroyuki Sakata, Ryuichi Iwakiri, Kazuma Fujimoto Background: The endoscopic High-frequency soft coagulation (ICC200 or 350, VIO300D;ERBE, Germany), recently developed in Japan, is available for management of gastric bleeding in cases of bleeding gastric ulcers and bleeding during endoscopic submucosal dissection. The aim of this study was to evaluate an efficacy of hemostasis with soft coagulation for bleeding gastric ulcers by comparing with hemoclips in a prospective, randomized trial. Objectives and Methods: During the period of April 2006 to March 2007, 96 patients of gastric ulcers with bleeding or nonbleeding vessels were enrolled in this study. All of 96 patients were randomly divided into two groups: Group I was treated with soft coagulation. Group II was treated with endoscopic clipping. We compared the two groups regarding initial hemostasis, recurrent bleeding, and required time. Results (table): Among the 48 patients in Group I, initial hemostasis was successful in 41 patients (85%) with soft coagulation alone. Among 48 patients in Group II, initial hemostasis was successful in 38 patients (79%) with clipping alone. Finally, the initial endoscopic hemostatic rate in Groups I and II was 98%. One patient in Group I (2%) and five patients in Group II (10%) were experienced recurrent bleeding within one week. The time required to achieve hemostasis was shorter in the Group I than Group II (9.211.1 vs 13.6 9.4 min; p ! 0.05). Conclusions: This prospective randomized study indicated the efficacy of soft coagulation method. The initial hemostasis ratio was not different between two tested groups. The time required to achieve hemostasis was shorter in the patients treated by soft coagulation and the rebleeding rate tended to be less compared to hemoclips, which might indicate usefulness of soft coagulation method for bleeding gastric lesions.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB117
613 Adding Balloon Sphincteroplasty to Sphincterotomy in Endoscopic Removal of Large Bile Duct Stones - A Randomized Controlled Trial Frances K. Cheung, Bing Hu, Ya MIN Pan, Yu BAO Zhou, Philip W. Chiu, Enders K. NG, Justin Wu, Francis K L. Chan, Joseph J. Sung, James Y. Lau Background: in patients with large bile duct stones, we hypothesize that the added use of balloon sphincteroplasty after endoscopic sphincterotomy may facilitate stone removal without increasing procedure related complications. Methods: Patients with suspected bile duct stones provided consent to trial participation prior to endoscopy. Those with bile duct stones in O13mm bile duct on cholangiogram were randomized to undergo sphincterotomy (ES) or sphincterotomy plus balloon dilatation (ES-BD) using CRE balloon up to 15mm (Boston Scientific) Patients with previous sphincterotomy who required extension to sphincterotomy were also included. Stones were retrieved using Dormia baskets, balloons or mechanical lithotripsy or their combinations. We excluded patients who required pre-cut sphincterotomy for access and those with cirrhosis or coagulopathy. Our primary outcome measure was the rate of complete bile duct clearance during first endoscopy. Secondary outcome measures included time for stone clearance, the use of mechanical lithotripsy and procedure related complications. Results: 86 patients were recruited from April 2005 to October 2008. Two patients were excluded due to violation of protocol (1 using precut as access and one received wrong assigned treatment). There were 42 patients in ES and 42 patients in ESBD group. Their ages, ASA grade, indication for ERCP, use of NSAID or aspirin, presence of peri-ampullary diverticulum were similar. The mean bile duct size was comparable (ES 16.5þ/-6.3 mm, ESBD 15.8þ/-4.5 mm). The mean stone size was similar (ES 10.9 þ/- 5.2 mm, ESBD 12.6 þ/- 4.7 mm; pZ0.12). The rate of stone clearance rate for ES and ESBD were 92% and 88% respectively (pZ0.71). The stone clearance time was 25 þ/- 13 mins and 28 þ/- 13 mins for ES and ESBD respectively (pZ0.28). Mechanical lithotripsy was required in 36% in ES group and 26% in ESBD group (pZ0.35). Complication rate was similar. 4 patients in ES group and 3 in ESBD group suffered from complications (1 mild pancreatitis, 2 severe sepsis, and 1 moderate sepsis in ES group; 1 hemorrhage of moderate severity, 1 mild pancreatitis and 1 mild sepsis in ESBD group). There was no mortality. Conclusion: Endoscopic balloon dilatation after sphincterotomy offer similar efficacy of stone retrieval and similar complication rate when compared with sphincterotomy alone in patients with dilated bile duct and large bile duct stones.
614 Intraductal Ultrasonography Can Discriminate Between Sclerosing Cholangitis Associated with Autoimmune Pancreatitis and Primary Sclerosing Cholangitis Kensuke Kubota, Shingo Kato, Noritoshi Kobayashi, Atsushi Nakajima Background: Intraductal ultrasonography (IDUS) produces high quality cross sectional images that are useful for the characterization of biliary structures affected with sclerosing cholangitis, however, the differentiation between sclerosing cholangitis associated with autoimmune pancreatitis (SC-AIP) and primary sclerosing cholangitis (PSC) has been challenging. No report has appeared to clarify the clinical significance of IDUS findings when making therapeutic decisions such as corticosteroid therapy in SC-AIP patients. Aim: To evaluate the characteristic IDUS features, which could potentially discriminate PSC patients from patients with SC-AIP. Methods: Nine AIP patients and 8 patients with PSC who had undergone IDUS followed by ERCP between April 2004 and November 2008 were identified from our database. IDUS was performed with a 20 MHz over the guidewire probe (UM-G20-29R: Olympus, Tokyo, Japan).IDUS images taken from hilar part of the bile duct and duodenal papilla in AIP and PSC patients were studied. We reviewed the following IDUS features of the bile duct as being potentially related to the differentiation of PSC cases from those with SC-AIP, such as the presence of symmetric thickness, wall thickness, the presence of a heterogenous internal echo and the presence of lateral mucosal lesions continuous to the hilar. Results: The outcomes of IDUS (SC-AIP vs PSC) were as follows: the presence of symmetrical thickness, 89% (8/9) vs: 25% (2/8); wall thickness (mm), 3.0 1.0 vs 2.1 0.7; the presence of a heterogeneous internal echo, 66.7% (6/9) vs 22.2% (2/9); and the presence of lateral mucosal lesions continuous to the hilar, 55.6% (5/9) vs 11.1% (1/9). Symmetrical thickness of the bile duct, a heterogeneous internal echo and the presence of lateral mucosal lesions continuous to the hilar were significantly more detected in cases of SC-PSC than PSC (p!0.05). The wall thickness tended to be prominent in SC-AIP cases than that of the PSC cases. No complication associated with IDUS occurred during or after the procedures. Conclusions: Our results suggest that IDUS findings such as symmetric thickness, wall thickness, the presence of a heterogenous internal echo and lateral mucosal lesions continuous to the hilar enhanced the differential diagnosis between SC-AIP and PSC. These findings support the routine use of endoscopic cholangiographic images in all patients with indeterminate sclerosing cholangitis.
www.giejournal.org
615 Video Cholangiopancreatoscopy (CP) with Narrow Band Imaging (NBI): Spectrum of Mucosal and Vascular Patterns in Patients with Pancreaticobiliary (PB) Pathology Raj J. Shah, Yang K. Chen Background: Clinical experience w/ CP-NBI is limited and there is no standard terminology for CP findings. The goals of the study are: 1) to determine if new CP equipped w/ NBI and improved optical resolution enhances CP findings and diagnosis (DX); 2) to provide descriptive terminology of CP-NBI findings across a full spectrum of PB diseases. Methods: Ongoing prospective study of pts undergoing CPNBI w/ Olympus CHF-Y0002 (3.4mm OD, 1.2mm channel, 70 up/down deflection, 90 FOV) and prototype duodenoscope. CP videos were reviewed by 2 MDs (RS, YC; 17 yr cumulative CP experience) to reach consensus on interpretation of white light (WL)/NBI findings for vessels, mucosa, and benign (BEN) or malignant (MAL) DX. CP findings: 1) discrete lesions - ulceration (ULC), polypoid/vegetative mass (MASS), infiltrative stricture (INFL), nodules (NDL), low (LPP) or finger-like papillary projections (FPP); 2) other mucosal findings e.g. atrophy (ATR), pseudodiverticulae (TIC) and 3) WL and NBI vascular patterns [none, minimal, or prominent; fine reticular capillary pattern (FRP) or tortuous/dilated ‘‘tumor’’ vessels (TDV)]. Results: 20 pts (mean 59yr, 14M) were enrolled from 9/08 to 11/08; 1pt was excluded from analysis for failure to traverse stricture with CP. Indications: indeterminate biliary stricture (NZ6), PSC dominant stricture (NZ6), suspected choledochal cyst (CC) (NZ4) or IPMN (NZ2), and extent of cholangioCA (CCA) (NZ1). Pts had mean of 2.5 (0-12) prior tissue sampling events. 7 (37%) had MAL DX based on CP visualization or tissue sampling; 5/7 (71%) had TDV. NBI enhanced imaging of TDV in 2 pts and detected TDV missed by WL in 1 pt; 2/7 pts with no TDV had MASS (NZ1), and INFL and FPP (NZ1). Mucosal characteristics in pts with MAL: INFL (NZ5), ULC (NZ3), FPP (NZ2), MASS (NZ1), LPP (NZ1), and NDL (NZ1). The following features seen in MAL are also seen in BEN: ULC (NZ3), LPP (NZ3, all w/ indwelling stents), and NDL (NZ3). Most common mucosal finding was TIC (NZ11 pts; 7 BEN, 4 MAL). Follow-up is ongoing but preliminary Dx: BEN PSC (NZ6), CCA (NZ6), CC (NZ3), IPMN (NZ1) and other (NZ3). CP findings in PSC: band-like scarring (NZ5), TIC (NZ3), ULC (NZ2), NDL (NZ2), and ATR (NZ1). In suspected CC: LPP (NZ2), TIC (NZ2), ATR (NZ2), ULC (NZ1), and prominent vs. minimal FRP by NBI vs. WL (NZ1). Conclusions: 1. Video CP enhances detection of ‘‘tumor vessels’’ 2. TIC is likely from cholestasis seen in both BEN and MAL diseases. 3. Band-like scarring is a BEN feature. 4. LPP may be stent-induced or seen with IPMN and CC. 5. This is the 1st report of CP-NBI findings in PSC and CC. 6. Long-term follow-up is planned to determine predictive value of video CP-NBI findings.
616 Endoscopic Hemostasis with High-Frequency Soft Coagulation for Bleeding Gastric Ulcer: Comparison with Metallic Hemoclips in a Prospective, Randomized Study Seiichiro Arima, Shinichi Ogata, Naoyuki Tominaga, Nanae Tsuruoka, Kotaro Mannen, Yasuhisa Sakata, Ryo Shimoda, Seiji Tsunada, Hiroyuki Sakata, Ryuichi Iwakiri, Kazuma Fujimoto Background: The endoscopic High-frequency soft coagulation (ICC200 or 350, VIO300D;ERBE, Germany), recently developed in Japan, is available for management of gastric bleeding in cases of bleeding gastric ulcers and bleeding during endoscopic submucosal dissection. The aim of this study was to evaluate an efficacy of hemostasis with soft coagulation for bleeding gastric ulcers by comparing with hemoclips in a prospective, randomized trial. Objectives and Methods: During the period of April 2006 to March 2007, 96 patients of gastric ulcers with bleeding or nonbleeding vessels were enrolled in this study. All of 96 patients were randomly divided into two groups: Group I was treated with soft coagulation. Group II was treated with endoscopic clipping. We compared the two groups regarding initial hemostasis, recurrent bleeding, and required time. Results (table): Among the 48 patients in Group I, initial hemostasis was successful in 41 patients (85%) with soft coagulation alone. Among 48 patients in Group II, initial hemostasis was successful in 38 patients (79%) with clipping alone. Finally, the initial endoscopic hemostatic rate in Groups I and II was 98%. One patient in Group I (2%) and five patients in Group II (10%) were experienced recurrent bleeding within one week. The time required to achieve hemostasis was shorter in the Group I than Group II (9.211.1 vs 13.6 9.4 min; p ! 0.05). Conclusions: This prospective randomized study indicated the efficacy of soft coagulation method. The initial hemostasis ratio was not different between two tested groups. The time required to achieve hemostasis was shorter in the patients treated by soft coagulation and the rebleeding rate tended to be less compared to hemoclips, which might indicate usefulness of soft coagulation method for bleeding gastric lesions.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB117