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EARLY AND LATE OUTCOME OF ENDOSCOPIC AMPULLARY RESECTION FOR EARLY NEOPLASIA OF THE PAPILLA OF VATER
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Abstracts / Digestive and Liver Disease 41S (2009), S1–S167
PEP. However, the guidewire could be the preferable technique when by the standard catheter the pancreatic duct had already been opacified. # R. Therapeutic endoscopy 5. ERCP
OC.01.7 EARLY AND LATE OUTCOME OF ENDOSCOPIC AMPULLARY RESECTION FOR EARLY NEOPLASIA OF THE PAPILLA OF VATER A. Repici, N. Pagano, G. Strangio, A. Carlino, G. Rando, F. Romeo, S. Danese, A. Malesci Dept. of Gastroenterology, IRCCS Istituto Clinico Humanitas, Milano Background and aim: Endoscopic papillectomy has become common in recent years as a non-invasive therapeutic procedure for tumor of the papilla of Vater without submucosal involvement. Aim of this study was to retrosepctively evaluate the early and late outcome of patients undergoing endoscopic amupllary resection fro early stage neoplasia of ampulla of Vater. Material and methods: All patients treated from 2004 to October 2008 because of early neoplasia of the ampulla of Vater suitable for endoscopic resection were included in the study. Data of the patients were retrived from electronic database of the Hospital. Resection technique, early complications, histopathologic report and long term follow-up were analyzed. Results: Twenty-two consecutive pts (14M/8F, mean age 59.8, range 52-81 y) were found in the electronic data base of the Hospital. All pts have been evaluated with EUS and CT scan before resection. Lift an cut technique with standard snare has been used in all but two patients in whom snaring was performed without prior injection because of the small size of the lesions. En-bloc resection was peromed in 18 pts, piecemeal (2 fragments) in 4 pts. Mean lesion size was 2.4 cm (range 1-6 cm). Pancreatic stenting was succesfully performed after snaring of the lesions in 21 patients (1 failure to cannulate the pancreatic duct). In 3 patients the lesion extended proximally in the bile duct and was further treated by APC ablation. Early complications occurred in 8 (36%) patients (7 bleeding and 1 mild pancreatitis). Severe bleeding requiring blood transfusion was observed in 2 patients (9%). No procedure-related mortality was observed. At histopathology 16 lesions were adenoma with low grade (6 patients) or high grade dysplasia. Superficial carcinoma not invading the submucosa was found in 5 patients. One patient with sm1 was referred for surgery. After a median follow-up of 25 months, adenoma recurrence was documented in 2 patients (one with biliary extension) and treated again by snaring and APC. Conclusions: Endoscopic ampullary resection is a viable method for the tretament of early stage neoplasia of the ampulla of Vater. Bleeding was in our experience the most common early complication. Long-term outcome is favourable for patients in whom the neoplasia is not invading the submucosa. Limited Biliary extension of the ampullary neoplasia is not an absolute controindication to endoscopic resection. # R. Therapeutic endoscopy 5. ERCP
OC.01.8 SELF-EXPANDABLE, REMOVABLE, COVERED METAL STENTS TO DILATE COMMON BILE DUCT STRICTURES SECONDARY TO CHRONIC PANCREATITIS: PRELIMINARY RESULTS A. Tringali ∗ , M. Mutignani, P. Familiari, V. Perri, G. Costamagna Digestive Endoscopy Unit - Catholic University, Roma Background and aim: Self-expandable metal stents (SEMS) are a medium-term solution in patients with CP and common bile duct stricture (CBD) refusing, or not candidate to surgery.
Aim of this prospective, single-arm feasibility study is to evaluate a new nitinol, fully covered, removable SEMS (Niti-S, Taewoong-medical, Korea) to obtain dilation of CP related CBD strictures. Material and methods: Inclusion criteria: a) patients with CP and symptomatic CBD that persist >3 months after placement of a single plastic stent; b) patients not candidate or refusing surgery. Exclusion criteria: a) CBD secondary to a pancreatic pseudocyst; b) persistence of alcohol abuse; c) age< 18; d) refusal to sign the informed consent. Primary end-point: evaluate the possibility of SEMS removal 6 months after placement. Secondary end-points: a) normalization of LFT’s during the period of stenting; b) need for endoscopic re-intervention due to SEMS malfunction; c) rate of CBD stricture resolution. The stent is removed after 6 months. The protocol was approved by the ethical committee. Aim was to enroll 15 patients. Two shapes of SEMS were used: unflared and flared. Results: Between Jan 2007 and Aug 2008 12 pts (mean age 51 y, 11 M) were enrolled. In 7 cases an unflared stent was inserted. 3 pts had cholangitis (1 with liver abscesses) after a mean of 3 months and the stent was found to be migrated intrabiliary and was removed with a foreign body forceps; a definitive SEMS was placed due to patients refusal of surgery. One patient underwent surgery for pancreatic abscess and hepaticojejunostomy. In 3 cases the stent was found to be migrated at the 6 months planned stent removal; these patients have normal LFT’s after a mean of 14 months. Due to the poor results stent design was changed to a flared one to prevent migration. In 5 cases this new stent was placed. One patient had cholangitis 40 days after stenting and the stent was found to be migrated and the patient was referred to surgery. Three patients have the stent in place with normal LFT’s after a mean of 4 months. In 1 case the stent was easily removed after 6 months with stricture resolution. Conclusions: Unflared removable covered SEMS showed high migration rate and related complications. Flared stent had promising results in obtaining dilation of biliary strictures related to CP. The study is ongoing. Long-term follow-up results are expected. # R. Therapeutic endoscopy 5. ERCP
OC.01.9 SELF-EXPANDABLE PARTIALLY COVERED METALLIC STENTS TO PALLIATE MALIGNANT BILIARY STRICTURES: EVALUATION OF THE COMVI STENT, PRELIMINARY RESULTS A. Tringali ∗ ,1 , M. Marchese 1 , S. Jang 2 , M. Mutignani 1 , P. Familiari 1 , H.G. Kim 3 , V. Perri 1 , D.K. Lee 2 , G. Costamagna 1 1
Digestive Endoscopy Unit - Catholic University, Roma; 2 Department of Internal Medicine - Yongdong Severance Hospital Yonsei University, Seoul, South Korea; 3 Department of Internal Medicine - Catholic University, Daegu, South Korea Background and aim: Endoscopic palliation of jaundice secondary to malignant biliary strictures by stents insertion is considered the treatment of choice. Self-Expandable Metal Stents (SEMS) have a longer patency than plastic. Membrane-coated SEMS can prevent tumor ingrowth leading to a longer patency than uncovered SEMS. Aim of this multi-centre, single-arm study is to prospectively evaluate a new nitinol partially covered SEMS (ComVi, Taewoong-Medical, Korea). Material and methods: Inclusion criteria: a) unresectable or unoperable malignancy leading to stenoses at the middle/distal common bile duct; b) absence of liver metastases; c) first attempt at endoscopic biliary drainage; d) at least 6 months life expectancy (Karnofsky score > 60). Exclusion criteria: a) ampullary cancer; b) hilar and/or intra-hepatic ducts malignancy; c) haemobilia d) cholangitis at the time of stenting;
Abstracts / Digestive and Liver Disease 41S (2009), S1–S167
PEP. However, the guidewire could be the preferable technique when by the standard catheter the pancreatic duct had already been opacified. # R. Therapeutic endoscopy 5. ERCP
OC.01.7 EARLY AND LATE OUTCOME OF ENDOSCOPIC AMPULLARY RESECTION FOR EARLY NEOPLASIA OF THE PAPILLA OF VATER A. Repici, N. Pagano, G. Strangio, A. Carlino, G. Rando, F. Romeo, S. Danese, A. Malesci Dept. of Gastroenterology, IRCCS Istituto Clinico Humanitas, Milano Background and aim: Endoscopic papillectomy has become common in recent years as a non-invasive therapeutic procedure for tumor of the papilla of Vater without submucosal involvement. Aim of this study was to retrosepctively evaluate the early and late outcome of patients undergoing endoscopic amupllary resection fro early stage neoplasia of ampulla of Vater. Material and methods: All patients treated from 2004 to October 2008 because of early neoplasia of the ampulla of Vater suitable for endoscopic resection were included in the study. Data of the patients were retrived from electronic database of the Hospital. Resection technique, early complications, histopathologic report and long term follow-up were analyzed. Results: Twenty-two consecutive pts (14M/8F, mean age 59.8, range 52-81 y) were found in the electronic data base of the Hospital. All pts have been evaluated with EUS and CT scan before resection. Lift an cut technique with standard snare has been used in all but two patients in whom snaring was performed without prior injection because of the small size of the lesions. En-bloc resection was peromed in 18 pts, piecemeal (2 fragments) in 4 pts. Mean lesion size was 2.4 cm (range 1-6 cm). Pancreatic stenting was succesfully performed after snaring of the lesions in 21 patients (1 failure to cannulate the pancreatic duct). In 3 patients the lesion extended proximally in the bile duct and was further treated by APC ablation. Early complications occurred in 8 (36%) patients (7 bleeding and 1 mild pancreatitis). Severe bleeding requiring blood transfusion was observed in 2 patients (9%). No procedure-related mortality was observed. At histopathology 16 lesions were adenoma with low grade (6 patients) or high grade dysplasia. Superficial carcinoma not invading the submucosa was found in 5 patients. One patient with sm1 was referred for surgery. After a median follow-up of 25 months, adenoma recurrence was documented in 2 patients (one with biliary extension) and treated again by snaring and APC. Conclusions: Endoscopic ampullary resection is a viable method for the tretament of early stage neoplasia of the ampulla of Vater. Bleeding was in our experience the most common early complication. Long-term outcome is favourable for patients in whom the neoplasia is not invading the submucosa. Limited Biliary extension of the ampullary neoplasia is not an absolute controindication to endoscopic resection. # R. Therapeutic endoscopy 5. ERCP
OC.01.8 SELF-EXPANDABLE, REMOVABLE, COVERED METAL STENTS TO DILATE COMMON BILE DUCT STRICTURES SECONDARY TO CHRONIC PANCREATITIS: PRELIMINARY RESULTS A. Tringali ∗ , M. Mutignani, P. Familiari, V. Perri, G. Costamagna Digestive Endoscopy Unit - Catholic University, Roma Background and aim: Self-expandable metal stents (SEMS) are a medium-term solution in patients with CP and common bile duct stricture (CBD) refusing, or not candidate to surgery.
Aim of this prospective, single-arm feasibility study is to evaluate a new nitinol, fully covered, removable SEMS (Niti-S, Taewoong-medical, Korea) to obtain dilation of CP related CBD strictures. Material and methods: Inclusion criteria: a) patients with CP and symptomatic CBD that persist >3 months after placement of a single plastic stent; b) patients not candidate or refusing surgery. Exclusion criteria: a) CBD secondary to a pancreatic pseudocyst; b) persistence of alcohol abuse; c) age< 18; d) refusal to sign the informed consent. Primary end-point: evaluate the possibility of SEMS removal 6 months after placement. Secondary end-points: a) normalization of LFT’s during the period of stenting; b) need for endoscopic re-intervention due to SEMS malfunction; c) rate of CBD stricture resolution. The stent is removed after 6 months. The protocol was approved by the ethical committee. Aim was to enroll 15 patients. Two shapes of SEMS were used: unflared and flared. Results: Between Jan 2007 and Aug 2008 12 pts (mean age 51 y, 11 M) were enrolled. In 7 cases an unflared stent was inserted. 3 pts had cholangitis (1 with liver abscesses) after a mean of 3 months and the stent was found to be migrated intrabiliary and was removed with a foreign body forceps; a definitive SEMS was placed due to patients refusal of surgery. One patient underwent surgery for pancreatic abscess and hepaticojejunostomy. In 3 cases the stent was found to be migrated at the 6 months planned stent removal; these patients have normal LFT’s after a mean of 14 months. Due to the poor results stent design was changed to a flared one to prevent migration. In 5 cases this new stent was placed. One patient had cholangitis 40 days after stenting and the stent was found to be migrated and the patient was referred to surgery. Three patients have the stent in place with normal LFT’s after a mean of 4 months. In 1 case the stent was easily removed after 6 months with stricture resolution. Conclusions: Unflared removable covered SEMS showed high migration rate and related complications. Flared stent had promising results in obtaining dilation of biliary strictures related to CP. The study is ongoing. Long-term follow-up results are expected. # R. Therapeutic endoscopy 5. ERCP
OC.01.9 SELF-EXPANDABLE PARTIALLY COVERED METALLIC STENTS TO PALLIATE MALIGNANT BILIARY STRICTURES: EVALUATION OF THE COMVI STENT, PRELIMINARY RESULTS A. Tringali ∗ ,1 , M. Marchese 1 , S. Jang 2 , M. Mutignani 1 , P. Familiari 1 , H.G. Kim 3 , V. Perri 1 , D.K. Lee 2 , G. Costamagna 1 1
Digestive Endoscopy Unit - Catholic University, Roma; 2 Department of Internal Medicine - Yongdong Severance Hospital Yonsei University, Seoul, South Korea; 3 Department of Internal Medicine - Catholic University, Daegu, South Korea Background and aim: Endoscopic palliation of jaundice secondary to malignant biliary strictures by stents insertion is considered the treatment of choice. Self-Expandable Metal Stents (SEMS) have a longer patency than plastic. Membrane-coated SEMS can prevent tumor ingrowth leading to a longer patency than uncovered SEMS. Aim of this multi-centre, single-arm study is to prospectively evaluate a new nitinol partially covered SEMS (ComVi, Taewoong-Medical, Korea). Material and methods: Inclusion criteria: a) unresectable or unoperable malignancy leading to stenoses at the middle/distal common bile duct; b) absence of liver metastases; c) first attempt at endoscopic biliary drainage; d) at least 6 months life expectancy (Karnofsky score > 60). Exclusion criteria: a) ampullary cancer; b) hilar and/or intra-hepatic ducts malignancy; c) haemobilia d) cholangitis at the time of stenting;