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P.1.104: A RANDOMIZED CLINICAL TRIAL COMPARING 22G AND 25G NEEDLES IN EUS-GUIDED FNA OF SOLID LESIONS
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Abstracts of the XVII National Congress of Digestive Diseases / Digestive and Liver Disease 43S (2011) S115–S264
prospective database. Patients who were finally diagnosed with an ampullary adenoma or an adenocarcinoma were excluded. The clinical history of the patients was reconstructed from the medical records and directly contacting the patients. Results: Eight patients (mean age 53.5 years [range 18–72 years]; 4 males) with rare ampullary tumors underwent ESP. In 7 cases the tumor was occasionally found during an EGD performed for vague symptoms. One patients, with an history of retroperitoneal tumors, presented with jaundice. Six of eight ESP were performed en-bloc. Early complications occurred in 2 cases and include a delayed bleeding treated by endoscopy and a mild acute pancreatitis. Six patients were eventually diagnosed with a well differentiated NET (including a gangliocytic paraganglioma); 1 with an adenomyoma; 1 with a solitary fibrous tumor. Mean tumor diameter was 12mm (range 8mm– 17mm). All the tumors were limited to the papilla of Vater. Microvascular invasion was seen at histology in a patient with a well differentiated NET. In one case margins of the resected specimens were undoubtedly clear; in two cases they were likely positive; in 5 cases they were indefinite. None of the patients underwent surgery, and they were followed-up for a mean of 28.7 months (range 5–68 months). All the patients are in good clinical conditions, an no recurrences have been observed during the follow-up. Conclusions: ESP can be successfully applied on small well differentiated NET, instead of a more aggressive surgery. Lacking a strong evidence on the long term efficacy of ESP for NET, a close follow up is recommended for these patients.
P.1.103 NEEDLE-KNIFE FISTULOTOMY TO GAIN SELECTIVE ACCESS TO THE COMMON BILE DUCT: A SERIES OF 105 PATIENTS M. Ayoubi ∗ , G. Sansoè, F. Castellino Ospedale Gradenigo, Torino, Italy Background and aim: Several endoscopic techniques have been described in cases of failed access to common bile duct. We describe our experience with needle–knife fistulotomy avoiding the papillary orifice followed by standard papillotomy and report its success rate and complications. Material and methods: Between January 2009 and October 2010, 319 consecutive patients (135 men, 185 women, median age 69 yrs, range 23–97) requiring ERCP and endoscopic treatment. Indication for the procedure included: choledocholithiasis (n= 204), biliary obstruction (n=106), postoperative leak (n=5), sclerosing cholangitis (n=2), Mirizzi’s syndrome (n=2). In all patients selective cannulation of the CBD was attemped through the Oddi sphincter with a wire-guided sphincterotome with no more than 4 attempts (no longer than 5 minutes). If the CBD cannulation was not achieved within 4 attempts fistulotomy was performed. Needle Knife fistulotomy technique is the following: a small incision is made a few millimeters above the papillary orifice. The starting point of fistulotomy on the papilla (distal third, midportion or proximal third) and the length of the incision can vary depending on type of pathology (stones, strictures etc.) and on the size of the papilla. If cannulation of the CBD through the opening is not possible, one or two additional small but deeper incisions must be made. After fistulotomia the CBD is cannulated through the incision with a wire-guided sphincterotome, and after deep cannulation a complete papillotomy can be done. All the procedures were performed by a single experienced endoscopist. Results: Selective cannulation through the Oddi sphincter with a wire-guided sphincterotome was successful within 4 attempts in 214 (67%) patients. The remaining 105 patients, in whom standard cannulation failed after 4 attempts, fistulotomy technique was performed and was successful in 88 (83.8%) patients. The overall complication rate for the standard cannulation was 5.9%; that for fistulotomy approach was 4.3%. (p=NS). Conclusions: In experienced hands, needle–knife fistulotomy is a safe and effective method for gaining quick access to the common bile duct in patients in whom standard cannulation is difficult.
P.1.104 A RANDOMIZED CLINICAL TRIAL COMPARING 22G AND 25G NEEDLES IN EUS-GUIDED FNA OF SOLID LESIONS L. Camellini 1 , G. Carlinfante 2 , F. Azzolini 1 , V. Iori ∗ ,1 , M. Cavina 1 , G. Sereni 1 , F. Decembrino 1 , C. Tioli 1 , C. Gallo 2 , I. Tamagnini 2 , R. Valli 2 , S. Piana 2 , C. Campari 3 , G. Gardini 2 , R. Sassatelli 1 1 Gastroenterology
and Digestive Endoscopy Unit Arcispedale S. Maria Nuova, Reggio Emilia, Italy; 2 Pathology Unit Arcispedale S. Maria Nuova, Reggio Emilia, Italy; 3 Public Health Department Ausl, Reggio Emilia, Italy Background and aim: The study was aimed to investigate whether the 25G is superior to the 22G needle, when used in EUSFNA of solid lesions. Material and methods: The study was a single centre randomized, clinical trial. The setting was a tertiary referral hospital, where EUSFNA of solid lesions was assisted by an on-site cytopathologist, blinded to the needle size. The main endpoint was the number of passes performed to obtain adequate samples. Crossover to the other type of needle was allowed after 5 passes, or when the gastroenterologist experienced difficulties in puncturing the lesions. Results: 129 solid lesions were randomised and data regarding 127 lesions were analyzed. The mean number of passes was 3.7 (+1.9) and 3.8 (+2) in 22G and 25G needle groups respectively (difference of means: 0.1; 95%CI: -0.59 to 0.79). 58/63 (92.1%) and 60/64 (93.7%) samples resulted to be adequate in 22G and 25G needle groups (difference: -1.6%; 95%CI: -12.1 to 8.9). Crossover to the other type of needle was performed in 11/63 (17.5%) and in 12/64 (18.7%) lesions in the two groups (difference: -1.2%; 95%CI: -16.2 to 13.8%). A crossover to the 25G needle was successfully performed in 4 masses in the uncinate process; these lesions were difficult to puncture using the 22G needle. Conclusions: Our study failed to demonstrate that the 25G is more effective than the 22G needle in EUS-FNA of solid lesions. However, targeting of lesions in the distal duodenum may be simplified by using the 25G needle.
P.1.105 RADIOFREQUENCY ABLATION (RFA) OF BARRETT’S ESOPHAGUS G. Diamantis ∗ , P. Bocus, S. Realdon, C. Castoro, G. Battaglia Istituto Oncologico Veneto - Iov, Padova, Italy Background and aim: Barrett’s esophagus (BE) is a premalignant condition which predisposes to esophageal adenocarcinoma (EAC) the incidence of which is rising more rapidly than any other cancer. Eradication of BE more than surveillance seems to be the correct therapeutic strategy. Radiofrequency ablation (RFA) is a novel and promising treatment modality for eradicating dysplastic and non dysplastic BE and can be used as a single-modality therapy or as a supplementary therapy after endoscopic resection (EMR) of visible abnormalities. We report the first single-center Italian experience. Material and methods: 19 subjects (17 males, median age 66 years) with histologic evidence of BE (8 with IM, 3 with indefinite for intraepithelial neoplasia, 2 patients with LGD, 5 with HGD and 1 with carcinoma in situ) were treated with RFA (max extension of BE was 12cm). The indications were: 12 cases of de novo eradication (5 patients post anti-reflux fundoplicatio) and 7 cases of supplementary therapy after EMR. Ablation with the Halo 360 catheter was performed in 13 cases, the Halo 90 was used in 5 patients and both in 1 case, during the first ablating session. Acetaminophen and continous infusion of tramadol were used analgesic therapy after the procedure for 24 hours. Our follow-up provides endoscopy with biopsies at 3, 6, 9 and 12 months after complete macroscopic eradication. All subjects were provided with esomeprazole 80 mg during the entire follow-up. Results: Complete response was defined as all biopsies negative for IM or dysplasia. 5/19 patients (26.3%) are still in treatment. 14/19 (73.6%) had at least one endoscopy after the end of the treatment. All patients had complete remission: 6/14 (42.8%) after the first ablation, 7 cases (50%) after a second ablation of the residual macroscopic glandular epithelium and 1 case (7.14%) after 3 ablative sessions. No complications were found except of one mild stenosis after Halo 360 ablation in a patient previously treated with EMR, completely resolved with endoscopic dilations.
Abstracts of the XVII National Congress of Digestive Diseases / Digestive and Liver Disease 43S (2011) S115–S264
prospective database. Patients who were finally diagnosed with an ampullary adenoma or an adenocarcinoma were excluded. The clinical history of the patients was reconstructed from the medical records and directly contacting the patients. Results: Eight patients (mean age 53.5 years [range 18–72 years]; 4 males) with rare ampullary tumors underwent ESP. In 7 cases the tumor was occasionally found during an EGD performed for vague symptoms. One patients, with an history of retroperitoneal tumors, presented with jaundice. Six of eight ESP were performed en-bloc. Early complications occurred in 2 cases and include a delayed bleeding treated by endoscopy and a mild acute pancreatitis. Six patients were eventually diagnosed with a well differentiated NET (including a gangliocytic paraganglioma); 1 with an adenomyoma; 1 with a solitary fibrous tumor. Mean tumor diameter was 12mm (range 8mm– 17mm). All the tumors were limited to the papilla of Vater. Microvascular invasion was seen at histology in a patient with a well differentiated NET. In one case margins of the resected specimens were undoubtedly clear; in two cases they were likely positive; in 5 cases they were indefinite. None of the patients underwent surgery, and they were followed-up for a mean of 28.7 months (range 5–68 months). All the patients are in good clinical conditions, an no recurrences have been observed during the follow-up. Conclusions: ESP can be successfully applied on small well differentiated NET, instead of a more aggressive surgery. Lacking a strong evidence on the long term efficacy of ESP for NET, a close follow up is recommended for these patients.
P.1.103 NEEDLE-KNIFE FISTULOTOMY TO GAIN SELECTIVE ACCESS TO THE COMMON BILE DUCT: A SERIES OF 105 PATIENTS M. Ayoubi ∗ , G. Sansoè, F. Castellino Ospedale Gradenigo, Torino, Italy Background and aim: Several endoscopic techniques have been described in cases of failed access to common bile duct. We describe our experience with needle–knife fistulotomy avoiding the papillary orifice followed by standard papillotomy and report its success rate and complications. Material and methods: Between January 2009 and October 2010, 319 consecutive patients (135 men, 185 women, median age 69 yrs, range 23–97) requiring ERCP and endoscopic treatment. Indication for the procedure included: choledocholithiasis (n= 204), biliary obstruction (n=106), postoperative leak (n=5), sclerosing cholangitis (n=2), Mirizzi’s syndrome (n=2). In all patients selective cannulation of the CBD was attemped through the Oddi sphincter with a wire-guided sphincterotome with no more than 4 attempts (no longer than 5 minutes). If the CBD cannulation was not achieved within 4 attempts fistulotomy was performed. Needle Knife fistulotomy technique is the following: a small incision is made a few millimeters above the papillary orifice. The starting point of fistulotomy on the papilla (distal third, midportion or proximal third) and the length of the incision can vary depending on type of pathology (stones, strictures etc.) and on the size of the papilla. If cannulation of the CBD through the opening is not possible, one or two additional small but deeper incisions must be made. After fistulotomia the CBD is cannulated through the incision with a wire-guided sphincterotome, and after deep cannulation a complete papillotomy can be done. All the procedures were performed by a single experienced endoscopist. Results: Selective cannulation through the Oddi sphincter with a wire-guided sphincterotome was successful within 4 attempts in 214 (67%) patients. The remaining 105 patients, in whom standard cannulation failed after 4 attempts, fistulotomy technique was performed and was successful in 88 (83.8%) patients. The overall complication rate for the standard cannulation was 5.9%; that for fistulotomy approach was 4.3%. (p=NS). Conclusions: In experienced hands, needle–knife fistulotomy is a safe and effective method for gaining quick access to the common bile duct in patients in whom standard cannulation is difficult.
P.1.104 A RANDOMIZED CLINICAL TRIAL COMPARING 22G AND 25G NEEDLES IN EUS-GUIDED FNA OF SOLID LESIONS L. Camellini 1 , G. Carlinfante 2 , F. Azzolini 1 , V. Iori ∗ ,1 , M. Cavina 1 , G. Sereni 1 , F. Decembrino 1 , C. Tioli 1 , C. Gallo 2 , I. Tamagnini 2 , R. Valli 2 , S. Piana 2 , C. Campari 3 , G. Gardini 2 , R. Sassatelli 1 1 Gastroenterology
and Digestive Endoscopy Unit Arcispedale S. Maria Nuova, Reggio Emilia, Italy; 2 Pathology Unit Arcispedale S. Maria Nuova, Reggio Emilia, Italy; 3 Public Health Department Ausl, Reggio Emilia, Italy Background and aim: The study was aimed to investigate whether the 25G is superior to the 22G needle, when used in EUSFNA of solid lesions. Material and methods: The study was a single centre randomized, clinical trial. The setting was a tertiary referral hospital, where EUSFNA of solid lesions was assisted by an on-site cytopathologist, blinded to the needle size. The main endpoint was the number of passes performed to obtain adequate samples. Crossover to the other type of needle was allowed after 5 passes, or when the gastroenterologist experienced difficulties in puncturing the lesions. Results: 129 solid lesions were randomised and data regarding 127 lesions were analyzed. The mean number of passes was 3.7 (+1.9) and 3.8 (+2) in 22G and 25G needle groups respectively (difference of means: 0.1; 95%CI: -0.59 to 0.79). 58/63 (92.1%) and 60/64 (93.7%) samples resulted to be adequate in 22G and 25G needle groups (difference: -1.6%; 95%CI: -12.1 to 8.9). Crossover to the other type of needle was performed in 11/63 (17.5%) and in 12/64 (18.7%) lesions in the two groups (difference: -1.2%; 95%CI: -16.2 to 13.8%). A crossover to the 25G needle was successfully performed in 4 masses in the uncinate process; these lesions were difficult to puncture using the 22G needle. Conclusions: Our study failed to demonstrate that the 25G is more effective than the 22G needle in EUS-FNA of solid lesions. However, targeting of lesions in the distal duodenum may be simplified by using the 25G needle.
P.1.105 RADIOFREQUENCY ABLATION (RFA) OF BARRETT’S ESOPHAGUS G. Diamantis ∗ , P. Bocus, S. Realdon, C. Castoro, G. Battaglia Istituto Oncologico Veneto - Iov, Padova, Italy Background and aim: Barrett’s esophagus (BE) is a premalignant condition which predisposes to esophageal adenocarcinoma (EAC) the incidence of which is rising more rapidly than any other cancer. Eradication of BE more than surveillance seems to be the correct therapeutic strategy. Radiofrequency ablation (RFA) is a novel and promising treatment modality for eradicating dysplastic and non dysplastic BE and can be used as a single-modality therapy or as a supplementary therapy after endoscopic resection (EMR) of visible abnormalities. We report the first single-center Italian experience. Material and methods: 19 subjects (17 males, median age 66 years) with histologic evidence of BE (8 with IM, 3 with indefinite for intraepithelial neoplasia, 2 patients with LGD, 5 with HGD and 1 with carcinoma in situ) were treated with RFA (max extension of BE was 12cm). The indications were: 12 cases of de novo eradication (5 patients post anti-reflux fundoplicatio) and 7 cases of supplementary therapy after EMR. Ablation with the Halo 360 catheter was performed in 13 cases, the Halo 90 was used in 5 patients and both in 1 case, during the first ablating session. Acetaminophen and continous infusion of tramadol were used analgesic therapy after the procedure for 24 hours. Our follow-up provides endoscopy with biopsies at 3, 6, 9 and 12 months after complete macroscopic eradication. All subjects were provided with esomeprazole 80 mg during the entire follow-up. Results: Complete response was defined as all biopsies negative for IM or dysplasia. 5/19 patients (26.3%) are still in treatment. 14/19 (73.6%) had at least one endoscopy after the end of the treatment. All patients had complete remission: 6/14 (42.8%) after the first ablation, 7 cases (50%) after a second ablation of the residual macroscopic glandular epithelium and 1 case (7.14%) after 3 ablative sessions. No complications were found except of one mild stenosis after Halo 360 ablation in a patient previously treated with EMR, completely resolved with endoscopic dilations.