Vincenzo Perri

Peroral endoscopic myotomy (POEM) for oesophageal achalasia: Preliminary results in humans

BACKGROUND Peroral endoscopic myotomy has been developed to provide a less invasive treatment for oesophageal achalasia compared to surgical cardiomyotomy. AIMS To report our initial experience on feasibility, safety and clinical efficacy of peroral endoscopic myotomy. METHODS Eleven patients (eight women, mean age 32, range 24-58) underwent an attempt at peroral endoscopic myotomy under general anaesthesia. After submucosal injection, a mucosal entry into the oesophageal submucosa, and a tunnel extending to the oesophagogastric junction and beyond into the stomach were created (total mean length: 15 ± 1.7 cm). Myotomy of the circular oesophageal and gastric muscle bundles was then achieved under direct vision (total mean length: 10.2 ± 2.8 cm). Haemostatic clips were used to close the mucosal entry. The Eckardt Score and manometry were used to evaluate the results. RESULTS Peroral endoscopic myotomy could be completed in 10 out of 11 patients (91%). Mean procedure time was 100.7 min (range 75-140 min). No major complication occurred. Clinical success was achieved in all patients at 1-month follow-up (Eckardt Score 7.1 vs. 1.1, p=0). Lower oesophageal sphincter pressure decreased from 45.1 to 16.9 mm Hg (p=0). CONCLUSIONS This initial experience with peroral endoscopic myotomy shows its safety and efficacy in the treatment of achalasia. Further studies are warranted to assess the long-term efficacy and to compare peroral endoscopic myotomy with other treatment modalities.

Extracorporeal shock wave lithotripsy of pancreatic stones in chronic pancreatitis: immediate and medium-term results

BACKGROUND Obstruction of the main pancreatic duct with upstream hypertension and dilation is a cause of pain in patients with chronic pancreatitis. Pancreatic ductal drainage can be achieved endoscopically by intraductal stone removal after endoscopic pancreatic sphincterotomy and/or by insertion of a pancreatic stent. Extracorporeal shock wave lithotripsy may be needed whenever stones cannot be removed by endoscopic procedures. We present our results in 35 patients treated with a combined endoscopic-extracorporeal shock wave lithotripsy approach with at least 6 months of follow-up. METHODS Thirty-five patients with severe chronic pancreatitis were treated by extracorporeal shock wave lithotripsy for endoscopically unretrievable obstructive stones. Extracorporeal shock wave lithotripsy was performed with an electromagnetic lithotriptor in 29 patients and an electrohydraulic lithotriptor in 6. RESULTS The procedures were well tolerated by the majority of patients. Fragmentation of stones was obtained in all cases while complete clearance and decompression of pancreatic duct were obtained in 26 of 35 (74.3%) and in 30 of 35 (85.7%) cases, respectively. There was no mortality related to the procedure. Morbidity was observed in 8 of 35 patients (22.8%). CONCLUSIONS Extracorporeal shock wave lithotripsy is a safe and effective treatment for endoscopically unretrievable pancreatic stones in the main pancreatic duct. Extracorporeal shock wave lithotripsy should be considered complementary and not an alternative to endoscopic drainage. Combined with endoscopy, extracorporeal shock wave lithotripsy may increase the success rate of nonsurgical treatment of patients with chronic pancreatitis.

Prospective evaluation of a new self-expanding plastic stent for inoperable esophageal strictures

BACKGROUND High stent cost is considered the major drawback of self-expanding metal stents for dysphagia palliation in patients with inoperable esophageal strictures. We report our experience with a self-expanding plastic (Polyflex) stent, the cost of which is half that of the metal stents. METHODS Between September 1999 and April 2001, 16 dysphagic patients (15 men; mean age, 69.4 +/- 14.5 years; range, 49-100 years; mean dysphagia score, 3.31 +/- 0.6) with esophageal strictures who underwent Polyflex stent placement (insertion device diameter, 12-14 mm; postexpansion inner stent diameter, 16-21 mm; stent length, 9, 12, and 15 cm) were studied prospectively. The strictures were caused by postsurgical recurrence of gastric/esophageal cancer at the anastomotic site in five patients, primary esophageal cancer in four patients, esophagocardia junction cancer in four patients, metastatic mediastinal lymph nodes from a primary lung cancer invading the esophagus in 1 patient, and benign peptic stricture in two elderly patients. All the patients were prospectively followed until death. RESULTS Stent insertion was technically successful in 12 patients (75%). Stent placement failed in four patients (25%) because of failure to pass the delivery catheter across the stricture in three patients and failure of the stent to open in one patient. Early and late stent migration occurred in two patients and 1 patient, respectively. Tumor overgrowth occurred in 1 patient. The mean dysphagia score 7 days after stent placement was 1.1 +/- 0.9. Mean survival was 100.6 +/- 71.2 days (range, 8-225 days). CONCLUSION Self-expanding Polyflex stents are safe and effective for inoperable esophageal strictures and have an acceptable technical success rate. Further experience, better selection criteria, and design improvements should improve results.

Endotherapy of postoperative biliary strictures with multiple stents: results after more than 10 years of follow-up

BACKGROUND Endoscopic dilation of postoperative biliary strictures with increasing numbers of stents was first described by our group in 2001 with promising results after a long-term follow-up (mean 4 years). OBJECTIVE To verify results of endoscopic treatment of postoperative biliary strictures at a very-long-term follow-up. DESIGN Single center, follow-up study. SETTING Tertiary-care, academic referral center. PATIENTS A group of 42 patients from our 2001 study, who had undergone endoscopic dilation of postoperative biliary strictures with the multiple endoscopic stenting technique, underwent systematic follow-up. The last telephone follow-up was done in September 2009. INTERVENTION Clinical conditions and the occurrence of new biliary symptoms during the follow-up period were assessed, and results of the most recent liver function tests and abdominal US were recovered. MAIN OUTCOME MEASUREMENTS Occurrence of cholangitis and liver function test evaluation during the follow-up period. RESULTS Of the 40 patients who were alive at the end of the study published in 2001, 5 (12.5%) died of unrelated causes after a mean of 6.7 years (range 3-13.3 years) from the end of treatment, without further biliary symptoms. The overall mean follow-up time for the remaining 35 patients (87.5%) was 13.7 years (range 11.7-19.8 years). Seven patients (20%) experienced recurrent acute cholangitis after a mean of 6.8 years (range 3.1-11.7 years) from the end of treatment. All 7 of these patients underwent ERCP. Four of the 7 patients had postoperative biliary stricture recurrence (n = 4/35, 11.4%) that was retreated endoscopically with placement of stents, and the other 3 patients had common bile duct stones (n = 3/35, 8.6%) that were extracted. No stricture or bile duct stone recurrences after retreatment were recorded after a mean follow-up period of a further 7.1 years (range 2.5-12.1 years). Twenty-eight patients remained asymptomatic with normal liver function test results and abdominal US results after a mean follow-up period of 13.7 years (range 11.7-19.8 years). LIMITATIONS Telephone follow-up. CONCLUSION Results of multiple endoscopic stenting for postoperative biliary strictures remain excellent even after a very-long-term follow-up. The stricture recurrence rate is low, and recurrences can be retreated endoscopically.

Peroral Endoscopic Myotomy for Esophageal Achalasia: Outcomes of the First 100 Patients With Short-term Follow-up

OBJECTIVE Aim of this study is to report the mid-term outcomes of a large series of patients treated with peroral endoscopic myotomy (POEM) in a single European center. BACKGROUND POEM is a recently developed treatment of achalasia, which combines the efficacy of surgical myotomy, with the benefits of an endoscopic procedure. Previous studies, including few patients with a short-term follow-up, showed excellent results on dysphagia relief. METHODS The first 100 adult patients treated in a single tertiary referral center were retrospectively identified and included in this study (41 men, mean age 48.4 years). Patients were treated according to a standard technique. Follow-up data, including clinical evaluation, and results of esophagogastroduodenoscopy (EGD), manometry, and pH monitoring were collected and analyzed. RESULTS POEM was completed in 94% of patients. Mean operative time was 83 minutes (49-140  minutes). No complications occurred. Patients were fed after a median of 2 days (1-4 days). A mean follow-up of 11 months (3-24 months) was available for 92 patients. Clinical success was documented in 94.5% of patients. Twenty-four-hour pH monitoring documented Gastro-Esophageal Reflux Disease (GERD) in 53.4% of patients. However, only a minority of patients had heartburn (24.3%) or esophagitis (27.4%), and these patients were successfully treated with proton-pump inhibitors. CONCLUSIONS Our results confirm the efficacy of POEM in a large series of patients, with a mean follow-up of 11 months. Should our results be confirmed by long-term follow-up studies, POEM may become one of the first-line therapies of achalasia in the next future.

COMBINED MODALITY TREATMENT IN UNRESECTABLE EXTRAHEPATIC BILIARY CARCINOMA

PURPOSE Cancers of the extrahepatic biliary tract are rare. Surgical resection is considered the standard treatment, but is rarely feasible. Several reports of combined modality therapy, including external beam radiation, often combined with chemotherapy and intraluminal brachytherapy, have been published. The purpose of this study was to evaluate the effect of chemoradiation plus intraluminal brachytherapy on response, local control, survival, and symptom relief in patients with unresectable or residual extrahepatic biliary carcinoma. METHODS AND MATERIALS From February 1991 to December 1997, 20 patients (14 male, 6 female; mean age 61 +/- 12 years; median follow-up 71 months) with unresectable (16 patients) or residual (4 patients), nonmetastatic extrahepatic bile tumors (common bile duct, 8; gallbladder, 1; Klatskin, 11) received external beam radiation (39.6-50.4 Gy); in 19 patients, 5-fluorouracil (96-h continuous infusion, days 1-4 at 1,000 mg/m(2)/day) was also administered. Twelve patients received a boost by intraluminal brachytherapy using (192)Ir wires of 30-50 Gy, prescribed 1 cm from the source axis. RESULTS During external beam radiotherapy, 8 patients (40%) developed grade 1-2 gastrointestinal toxicity. Four patients treated with external-beam plus intraluminal brachytherapy had a clinical response (2 partial, 2 complete) after treatment. For the total patient group, the median survival and time to local progression was 21.2 and 33.1 months, respectively. Distant metastasis occurred in 10 (50%) patients. Two patients who received external beam radiation plus intraluminal brachytherapy developed late duodenal ulceration. Two patients with unresectable disease survived more than 5 years. CONCLUSION Our data suggest that chemoradiation plus intraluminal brachytherapy was relatively well-tolerated, and resulted in reasonable local control and median survival. Further follow-up and additional research is needed to determine the ultimate efficacy of this regimen. New chemoradiation combinations and/or new treatment strategies (neoadjuvant chemoradiation) may contribute, in the future, to improve these results.

Efficacy of main pancreatic-duct endoscopic drainage in patients with chronic pancreatitis, continuous pain, and dilated duct

BACKGROUND The aim of endoscopic treatment in patients with chronic pancreatitis is to achieve decompression of the pancreatic duct, because duct obstruction with increased pressure within the duct is one of the leading causes of pain in these patients. The majority of patients suffer from relapsing pain, thus making it difficult to evaluate the efficacy of therapy. The outcome of endoscopic treatment on pain has been evaluated in patients with continuous pain (present for more than 1 month, at least 5 days per week, requiring daily analgesic therapy) and dilated duct. METHODS Of 343 patients who underwent endotherapy for chronic pancreatitis in a 15-year period, 22 (6.4%)(19 men, mean age 48 years, alcohol abuse 14) had continuous pain and a dilated pancreatic duct. RESULTS Endotherapy was successful in all patients, with no procedure-related mortality and only mild complications. Pain disappeared, and analgesics could be discontinued in all patients immediately after endotherapy. Six patients are pain free after a mean period of 5.5 years. One pain-free patient died after 3.4 years from myocardial infarction. Five patients were successfully endoscopically re-treated for pain relapses. Four patients underwent surgery for frequent pain relapses after a mean period of 2.5 years. Six patients were lost to follow-up. CONCLUSIONS Endotherapy should be considered as the initial treatment of choice in patients with chronic pancreatitis, dilated duct, and continuous pain.

Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome

BACKGROUND Bariatric surgery is associated with specific complications and mortality. Transoral gastroplasty (TOGA) is a transoral restrictive bariatric procedure that might offer the benefits of surgery with a reduced complication rate. OBJECTIVE To evaluate the safety and efficacy of TOGA at 12-month follow-up. DESIGN Prospective, multicenter, single-arm trial. SETTING Two tertiary-care referral medical centers. PATIENTS This study involved 67 patients (average age 41.0 years, 47 women, baseline body mass index [BMI] 41.5 kg/m(2); 20 patients with BMI <40). INTERVENTION The TOGA procedures were performed by using 2 stapling devices that were used to create a small, restrictive pouch along the lesser gastric curvature. The pouch is designed to give the patient a sustained feeling of satiety after small meals. MAIN OUTCOME MEASUREMENTS Excess weight loss, excess BMI loss, safety, and improvements in quality of life, obesity-related comorbidities, and medication use. RESULTS Fifty-three patients were available at the 12-month follow-up. Excess BMI loss was 33.9%, 42.6%, and 44.8% at 3, 6, and 12 months, respectively. At 12 months, excess BMI loss was 52.2% for patients with a baseline BMI of <40.0 and 41.3% for patients with a baseline BMI of ≥ 40.0 (P < .05). At 12 months, hemoglobin A(1c) levels decreased from 7.0% at baseline to 5.7% (P = .01); triglyceride levels decreased from 142.9 mg/dL to 98 mg/dL (P < .0001); high-density lipoprotein levels increased from 47.0 mg/dL to 57.5 mg/dL (P < .0001). Two complications occurred: a case of respiratory insufficiency and an asymptomatic pneumoperitoneum treated conservatively. LIMITATIONS Small number of patients. Short-term follow-up. Twenty-one percent of patients were not available for the 12-month follow-up. CONCLUSION The TOGA procedure allowed a substantial weight loss 1 year after the operation without severe complications. A long-term evaluation is needed before definitive conclusions can be drawn.

Intraluminal brachytherapy in the treatment of pancreas and bile duct carcinoma

PURPOSE A new method of palliation of malignant obstructive jaundice is presented. METHODS AND MATERIALS Twelve patients with carcinoma of the extrahepatic bile ducts (EHBD-five patients) or pancreatic head (PH-seven patients) received radiation therapy between 1988 and 1991. Percutaneous transhepatic biliary drainage was performed in four EHBD patients and an endoprosthesis was placed during endoscopic retrograde cholangiopancreatography (ERCP) in the other eight patients. All 12 received intraluminal brachytherapy (ILBT): 20-50 Gy calculated at 1 cm from the Iridium-192 (192Ir) wire. In four PH patients the source was placed in the duct of Wirsung; in the other eight patients ILBT was performed via the common bile duct. Five of the seven PH patients and one of the five EHBD patients received External Beam Radiation Therapy (EBRT): 26-50 Gy, alone or with concomitant 5-Fluorouracil (5-FU). RESULTS Cholangitis occurred in six patients. Three PH patients treated with EBRT+ILBT developed gastrointestinal toxicities. With a minimum follow-up of 18 months, median survival times were 14 months (EHBD) and 11.5 months (PH); one of the seven PH patients is alive (29 months) and two of the EHBD patients are alive (18 and 43 months). All patients had satisfactory control of jaundice. CONCLUSIONS The results in the EHBD patients suggest that the addition of ILBT after biliary drainage prolongs survival. Further experience is necessary to determine whether ILBT in the common bile duct and/or in the duct of Wirsung may be, in PH patients, an alternative boost technique to Interstitial Brachy-therapy (IBT) or Intraoperative Electron Beam Radiation Therapy (IOEBRT).

Peroral Endoscopic Myotomy for the Treatment of Achalasia in Children

ABSTRACT Peroral endoscopic myotomy (POEM) is a new endoscopic technique for the treatment of esophageal achalasia, with excellent results in adults. Three children with classic-type achalasia (mean age 9.6 years) underwent POEM in a single center. Mean basal lower esophageal sphincter pressure and Eckard score were 34.6 mmHg and 5.3, respectively. Mean length of myotomy was 10 cm. On average, POEM was completed in 60.6 minutes. No patients experienced postoperative complications or gastroesophageal reflux disease. In the 2 patients who completed a 12-month follow-up, complete symptoms relief was documented (Eckard score 0), as well as a significant drop of the basal lower esophageal sphincter pressure.