Monitoring Cochlear Health With Intracochlear Electrocochleography During Cochlear Implantation: Findings From an International Clinical Investigation.

OBJECTIVES: Electrocochleography (ECochG) is emerging as a tool for monitoring cochlear function during cochlear implant (CI) surgery. ECochG may be recorded directly from electrodes on the implant array intraoperatively. For low-frequency stimulation, its amplitude tends to rise or may plateau as the electrode is inserted. The aim of this study was to explore whether compromise of the ECochG signal, defined as a fall in its amplitude of 30% or more during insertion, whether transient or permanent, is associated with poorer postoperative acoustic hearing, and to examine how preoperative hearing levels may influence the ability to record ECochG. The specific hypotheses tested were threefold: (a) deterioration in the pure-tone average of low-frequency hearing at the first postoperative follow-up interval (follow-up visit 1 [FUV1], 4 to 6 weeks) will be associated with compromise of the cochlear microphonic (CM) amplitude during electrode insertion (primary hypothesis); (b) an association is observed at the second postoperative follow-up interval (FUV2, 3 months) (secondary hypothesis 1); and (c) the CM response will be recorded earlier during electrode array insertion when the preoperative high-frequency hearing is better (secondary hypothesis 2). DESIGN: International, multi-site prospective, observational, between groups design, targeting 41 adult participants in each of two groups, (compromised CM versus preserved CM). Adult CI candidates who were scheduled to receive a Cochlear Nucleus CI with a Slim Straight or a Slim Modiolar electrode array and had a preoperative audiometric low-frequency average thresholds of ≤80 dB HL at 500, 750, and 1000 Hz in the ear to be implanted, were recruited from eight international implant sites. Pure tone audiometry was measured preoperatively and at postoperative visits (FUV1 and follow-up visit 2 [FUV2]). ECochG was measured during and immediately after the implantation of the array. RESULTS: From a total of 78 enrolled individuals (80 ears), 77 participants (79 ears) underwent surgery. Due to protocol deviations, 18 ears (23%) were excluded. Of the 61 ears with ECochG responses, amplitudes were < 1 µV throughout implantation for 18 ears (23%) and deemed "unclear" for classification. EcochG responses >1 µV in 43 ears (55%) were stable throughout implantation for 8 ears and compromised in 35 ears. For the primary endpoint at FUV1, 7/41 ears (17%) with preserved CM had a median hearing loss of 12.6 dB versus 34/41 ears (83%) with compromised CM and a median hearing loss of 26.9 dB ( p < 0.014). In assessing the practicalities of measuring intraoperative ECochG, the presence of a measurable CM (>1 µV) during implantation was dependent on preoperative, low-frequency thresholds, particularly at the stimulus frequency (0.5 kHz). High-frequency, preoperative thresholds were also associated with a measurable CM > 1 µV during surgery. CONCLUSIONS: Our data shows that CM drops occurring during electrode insertion were correlated with significantly poorer hearing preservation postoperatively compared to CMs that remained stable throughout the electrode insertion. The practicality of measuring ECochG in a large cohort is discussed, regarding the suggested optimal preoperative low-frequency hearing levels ( < 80 dB HL) considered necessary to obtain a CM signal >1 µV.

Multi-electrode sequential versus single electrode stimulation to elicit the stapedial reflex during cochlear implantation: Correlation with maximum comfort level.

OBJECTIVES: To assess whether electrical stimulation sequentially delivered through 4 electrodes located in different cochlear areas may elicit the stapedial reflex at lower levels compared to single electrode stimulation and to correlate the sequentially obtained values with the maximum comfort level (C-level). PATIENTS AND METHODS: A retrospective study was performed on 35 post-verbal adult patients (age 19-80 years) consecutively implanted in 2 cochlear implant centers, evaluating the level of stimulation (pulse width) necessary to electrically evoke the stapedial reflex with two different stimulation modalities: single electrode versus sequential 4 electrode stimulation. Threshold values were compared with C-level obtained at activation. RESULTS: The average differences of pulse width and C-level were significantly smaller (P<0.0001) when the stapedial reflex was obtained with the sequential stimulation modality and reached statistical significance for every single electrode (P<0.0001). CONCLUSIONS: Stapedial reflex thresholds obtained with sequential stimulation through 4 different electrodes significantly correlate to the C-level obtained at the first setting and may be helpful in defining the upper limit of the dynamic field during initial CI mapping.

Bilateral congenital cholesteatoma: report of an emblematic case.

OBJECTIVES: To describe a case of bilateral congenital cholesteatoma (CC) of the middle ear with a focus on diagnostic clues, treatment and a review of the pertinent literature. PATIENT AND METHODS: An 8-year-old child was incidentally noted to have whitish bilateral retrotympanic masses with normal hearing and referred to our department in January 2005. Microscopic examination of the ears and CT scan of the temporal bones led to a presumptive diagnosis of bilateral CC. The lesion on the right side was surgically removed, followed by that on the left side after 6 months; a retroauricular transcanal approach was adopted in both ears. RESULTS: Anatomic integrity of the middle ear was achieved with preservation of pre-operative hearing. No signs of recurrence were evident 20 months after the last surgery. CONCLUSIONS: Bilateral CC is a rare finding but otologists must be aware of it. Surgery must be planned early in order to achieve radical removal of the pathology and the preservation of middle ear structures.

Prospective multicenter quality assessment of endotherapy of biliary stones: does center volume matter?

BACKGROUND AND STUDY AIMS: To study the effectiveness of endoscopic treatment for biliary stones in a large case list of patients treated in units with different experience and different workloads in a region of northern Italy. PATIENTS AND METHODS: We prospectively studied 700 patients undergoing endoscopic retrograde cholangiopancreatography or sphincterotomy, in 14 units (> or < 200 examinations/year), for their first treatment of biliary stones. The difficulty of the examinations, the results in terms of clearance of the stones, and the late outcomes (24 months) were recorded. A questionnaire (GHAA-9modified) was administered 24 hours and 30 days after the procedure to measure patient satisfaction. RESULTS: There were six units with a heavy workload and eight with a light schedule. There were 176 (25.1 %) difficult examinations (Schutz grades 3, 4, and 5). Stones were found in 580 (82.9 %) and were cleared in 504 of these patients (86.9 %). No differences were observed in the clearance of stones for the different groups of difficulty and high- and low-volume centers. Over the 24-month follow-up period, 96 patients (13.7 %) complained of recurrent symptoms and 44 (6.3 %) had proof of stones. In all, 603 questionnaires were evaluable and more than 80 % of patients expressed satisfaction. CONCLUSIONS: Our findings confirm the effectiveness of endoscopic treatment of biliary stones. However, the number of patients with symptoms (13.7) after 24 months, with or without persistence of stones, was not insignificant. It is feasible to record patient satisfaction, and in this series patients stated they were satisfied. Criticism mostly concerned pain control and explanations provided before the examination.

Use of the laparoscopic-endoscopic approach, the so-called "rendezvous" technique, in cholecystocholedocholithiasis: a valid method in cases with patient-related risk factors for post-ERCP pancreatitis.

BACKGROUND: Several studies have shown the efficacy and effectiveness of the combined endoscopic-laparoscopic "rendezvous" technique for treatment of gallbladder and bile duct stones without complications, particularly pancreatitis. The so-called rendezvous technique consists of laparoscopic cholecystectomy standards with intraoperative cholangiography followed by endoscopic sphincterotomy (EST). The sphincterotome is driven across the papilla through a guidewire inserted by the transcystic route. This method allows easier and faster cannulation, thus avoiding papillary edema and pancreatic trauma. The aim of this study was to evaluate whether this method is effective in eliminating ductal stones and to verify whether the risk of postprocedure pancreatitis is diminished. METHODS: From January 2002 to September 2004, we enrolled 256 patients with cholecystocholedolithiasis detected by transabdominal ultrasound and magnetic resonance cholangiopancreatography. One hundred and twenty of these had one or more patient-related risk factors for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, so they were randomized into two groups of 60 patients. In group A, the patients were treated in a single step with videolaparoscopic cholecystectomy, intraoperative cholangiography, and EST during the surgical procedure with the rendezvous technique. In group B, preoperative ERCP and EST were performed by using a traditional method of bile duct cannulation. RESULTS: No cases of post-ERCP pancreatitis were observed in group A, whereas six cases of acute post-ERCP pancreatitis occurred in group B (five mild and one moderate) (p = 0.0274). No procedure-related mortality was recorded. CONCLUSION: In cholecysthocholedocholithiasis, the combined laparoscopic-endoscopic approach prevents post-ERCP pancreatitis in cases with patient-related risk factors for this complication.

Octreotide 24-h prophylaxis in patients at high risk for post-ERCP pancreatitis: results of a multicenter, randomized, controlled trial.

BACKGROUND: Pharmacological prophylaxis of post-ERCP pancreatitis is costly and not useful in most non-selected patients, in whom the incidence of pancreatitis is 5% or less. However, it could be useful and probably cost-effective, in patients at high risk for this complication, where the post-procedure pancreatitis rate is 10% and more. AIM: To assess the efficacy of octreotide in reducing the incidence and severity of post-ERCP pancreatitis and procedure-related hospital stay, in subjects with known patient-related risk factors. METHODS: A total of 120 patients were randomly allocated to receive octreotide or not, in a multicentre, randomized, controlled trial. The drug was given subcutaneously, 200 microg t.d.s., starting 24 h before the ERCP procedure, in patients with either sphincter of Oddi dysfunction, or a history of relapsing pancreatitis or post-ERCP pancreatitis, or who were aged under 35 years, or who had a small common bile duct diameter (< 8 mm). RESULTS: A total of 114 patients (58 in the octreotide group and 56 in the control group) completed the trial. Post-procedure pancreatitis occurred in seven octreotide-treated patients (12.0%) and eight controls (14.3%). The two groups showed no significant differences in the incidence or severity of pancreatitis. Twenty-four hours after the procedure, severe hyperamylasemia (more than five times the upper normal limit) without pancreatic-like pain was recorded in three octreotide-treated patients (5.2%) and six controls (10.7%), the difference being not significant. CONCLUSION: Twenty-four-hour prophylaxis with octreotide proved ineffective in preventing post-ERCP pancreatitis and in avoiding 24-h severe hyperamylasemia in high-risk patients.

Gynecomastia and the complete circumareolar approach in the surgical management of skin redundancy.

Gynecomastia is a benign enlargement of the male breast due to a physiological or pathological factor that interferes with the balance between estrogens and androgens in the serum. Gynecomastia itself requires no treatment unless the persistent enlargement of the male breast is a source of embarrassment and/or distress for the adolescent or adult man. The indications for the surgical treatment of gynecomastia are founded on two main objectives: (1) the restoration of male chest shape and (2) diagnostic evaluation of suspected breast lesions. The diagnostic evaluation begins with an adequate history and a thorough breast examination helped by laboratory tests and instrumental research. Several approaches for surgical treatment have been described in the literature. Some problems arise in patients who have significant enlargement and ptosis of the breast that will require skin reduction and in some patients requiring nipple-areola complex reduction. The authors believe that the complete circumareolar technique with purse-string suture creates the best aesthetic results, with fewer complications, in patients with moderate and severe ptotic glandular breast enlargements that have skin redundancy combined with areolar enlargement. From 1995 through 1999, a total of 10 male patients with moderate to severe gynecomastia were treated surgically using a complete circumareolar approach. All patients achieved a good aesthetic contour of the chest. Only two patients required a revision of the circumareolar scar to correct postoperative enlargement.

Idiopathic recurrent pancreatitis: long-term results after ERCP, endoscopic sphincterotomy, or ursodeoxycholic acid treatment.

OBJECTIVE: In about 30% of cases, the etiology of acute recurrent pancreatitis remains unexplained, and the term "idiopathic" is currently used to define such disease. We aimed to evaluate the long-term outcome of patients with idiopathic recurrent pancreatitis who underwent endoscopic cholangiopancreatography (ERCP) followed by either endoscopic biliary (and seldom pancreatic) sphincterotomy or ursodeoxycholic acid (UDCA) treatment, in a prospective follow-up study. METHODS: A total of 40 consecutive patients with intact gallbladder entered the study protocol after a 24-month observation period during which at least two episodes of pancreatitis occurred. All patients underwent diagnostic ERCP, followed by biliary or minor papilla sphincterotomy in cases of documented or suspected bile duct microlithiasis and sludge, type 2 sphincter of Oddi dysfunction, or pancreas divisum with dilated dorsal duct. Patients with no definite anatomical or functional abnormalities received long-term treatment with UDCA. After biliary sphincterotomy, patients with further episodes of pancreatitis underwent main pancreatic duct stenting followed by pancreatic sphincterotomy if the stent had proved to be effective. RESULTS: ERCP found an underlying cause of pancreatitis in 70% of cases. Patients were followed-up for a period ranging from 27 to 73 months. Effective therapeutic ERCP or UDCA oral treatment proved that occult bile stone disease and type 2 or 3 sphincter of Oddi dysfunction (biliary or pancreatic segment) had been etiological factors in 35 of the 40 cases (87.5%) After therapeutic ERCP or UDCA, only three patients still continued to have episodes of pancreatitis. CONCLUSIONS: Diagnostic and therapeutic ERCP and UDCA were effective in 92.5% of our cases, over a long follow-up, indicating that the term "idiopathic" was justified only in a few patients with acute recurrent pancreatitis.

Twenty-four-hour serum amylase predicting pancreatic reaction after endoscopic sphincterotomy.

BACKGROUND AND STUDY AIMS: Acute pancreatitis is still the most common complication after endoscopic sphincterotomy (ES) and cholangiopancreatography (ERCP). The aim of this study was to detect the time when the peak of serum amylase was predictive for postprocedure pancreatitis or long-lasting severe hyperamylasemia, in order to plan the follow-up of patients. METHODS: Serum amylase activity was measured in a prospective series of 409 consecutive patients after ES, immediately before ES and two, four, eight and 24 hours thereafter; the two, four and eight-hour data were compared with those at 24 hours and with the outcome. Evaluation was done separately for the 198 cases with pancreatic duct opacification and for the 202 cases at high risk for postprocedure pancreatitis. RESULTS: Twenty-four hours after ES, amylase was still more than five times the upper normal limit in 26 patients, associated with pancreatic-like pain in 19 of them (mild/moderate pancreatitis) and asymptomatic in the remaining seven (long-lasting severe hyperamylasemia). There was a significant difference at all sampling times between the 26 patients with 24-hour severe hyperamylasemia and those with the lower level. Although the sensitivity of amylase measurement in detecting pancreatitis was highest at eight hours, in practice the four-hour assessment appears a reliable predictor. Almost all patients with serum amylase levels more than five times the upper normal limit at four, eight and 24 hours had had pancreatic duct opacification. In contrast, patient-related risk factors for postprocedure pancreatitis did not play a significant role in the present series. CONCLUSIONS: Serum amylase assessment four hours after ES is a reliable, cost-effective follow-up and minimizes the likelihood of underestimating the risk of post-procedure pancreatic reaction. It should be recommended particularly in out-patients and when pancreatic duct opacification has occurred.

Serum amylase measured four hours after endoscopic sphincterotomy is a reliable predictor of postprocedure pancreatitis.

OBJECTIVE: Acute pancreatitis is a common complication after endoscopic sphincterotomy (ES) and endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study was to detect the time when the peak of serum amylase was predictive for pancreatitis or severe hyperamylasemia, to plan a prolonged follow-up in the hospital and for outpatients. METHODS: In a prospective series of 409 consecutive patients undergoing ES, serum amylase activity was measured immediately before the procedure and 2, 4, 8, and 24 h thereafter; the data obtained at 2, 4, and 8 h were compared with those at 24 h and with the outcome. Sensitivity for long-lasting severe hyperamylasemia (more than five times the upper normal limit) and pancreatitis were also defined for all sampling times. RESULTS: At 24 h after ES, amylase was still more than five times the upper normal limit in 26 patients, 19 of whom had mild/moderate acute pancreatitis. There was a significant difference (p < 0.01 at all sampling times) between the 26 patients with 24-h severe hyperamylasemia and those with lower levels. The sensitivity of amylase measurement in detecting pancreatitis or long-lasting severe hyperamylasemia was highest at 8 h. However, the 4-h assessment appears to be a reliable predictor in practice, as more than two-thirds of cases of pancreatitis (all but one with computed tomography-confirmed pancreatitis) occurred among patients whose 4-h amylasemia was higher than five times the upper normal limit. CONCLUSIONS: Serum amylase assessment 4 h after ES minimizes the likelihood of underestimating the risk of postprocedure pancreatitis. It is therefore a reliable, cost-effective follow-up, particularly in outpatients.

Higher prevalence of Helicobacter pylori infection in dyspeptic patients who do not have gastric phase III of the migrating motor complex.

BACKGROUND: So far, only a few and conflicting data are available about the possible correlation between Helicobacter pylori infection and disorders of gastrointestinal motility. METHODS: In the present study we have evaluated the interdigestive manometric recordings from the stomach and duodenum of 100 consecutive dyspeptic patients, to ascertain whether the absence of phase III of the migrating motor complex (MMC) might be associated with a different prevalence of H. pylori infection. All the patients who entered a protocol study for functional dyspepsia had endoscopic examinations of the upper gastrointestinal tract with at least two biopsy specimens from both the gastric antrum and corpus (for histologic evaluation, with search for Helicobacter-like organisms). Then, 240-min interdigestive manometric recordings, with evaluation of activity fronts (phase III of the MMC), starting from the stomach and the duodenum, were made. RESULTS AND CONCLUSIONS: The data obtained suggest that in patients without evidence of gastric phase III of MMC the prevalence of H. pylori colonization is significantly (P = 0.032) higher.

Long-term prophylactic administration of octreotide reduces the rise in serum amylase after endoscopic procedures on Vater's papilla.

The pancreas commonly reacts to endoscopic papillosphincterotomy (EST) with a rise in serum amylase, and acute pancreatitis may also develop. The long-acting somatostatin analogue octreotide has recently been proposed for prevention of colangiopancreatography (ERCP)/EST-induced pancreatic reaction. Therefore, we tested the prophylactic effects of a subcutaneous 3-day administration of octreotide to 60 consecutive patients undergoing ERCP and EST. They were randomly allocated to receive either 200 micrograms octreotide t.i.d. for 3 days (30 cases) or placebo (control group, 30 cases) before the procedure. On the day of the examination, serum amylase levels were determined at baseline and 2, 4, 8, and 24 h thereafter. In the patients as a whole, the increases were statistically significant at 4 h (p < 0.01) and 8 h (p < 0.01). Epigastric pain occurred in 2 patients in the octreotide group and in 13 control subjects (p < 0.001). Even in some patients who had had previous episodes of relapsing pancreatitis, the rise in serum amylase was significantly lower in the octreotide group than in the control group at 4 h (p < 0.01), 8 h (p = 0.05), and 24 h (p = 0.05). Our data suggest that 3 days of prophylactic treatment with octreotide is effective for reducing the rise in serum amylase after EST/ERCP and could be proposed for patients with relapsing pancreatitis and other risk conditions before the Vater's papilla manipulation.

Helicobacter pylori serology in chronic gastritis with antral atrophy and negative histology for Helicobacter-like organisms.

It has been suggested that there may be a correlation between Helicobacter pylori (Hp) infection and precancerous lesions of the stomach. However, histological evaluation of bacterial colonization in chronic atrophic gastritis shows a relatively low prevalence of the microorganism, which does not support the hypothesis. The aim of our study was to investigate the Hp serology in 95 patients with chronic gastritis with antral atrophy, with (27 cases) and without (68 cases) intestinal metaplasia, and without Helicobacter-like organisms in antral and corpus biopsy specimens. For all subjects, serum anti-Hp immunoglobulin IgG was identified by a fluorescent immunoenzymatic method (Helori-test; Eurospital), and mucosal atrophy and activity were graded histologically (Sydney System score). The serum Hp-antibody status documented the presence of current bacterial infections in 64 of 95 (67.4%) patients and previous infections in another 17 subjects. In only 14.7% of cases was there no evidence of current or previous infection. These subjects had less severe mucosal atrophy and lower inflammatory scores. In addition, there were no cases of intestinal metaplasia in such subjects. The high prevalence of Hp infection confirms the primary role of the microorganism in the pathogenesis of chronic gastritis with antral atrophy, although the bacterium is no longer present in the advanced stages of such disease. The histological evaluation of Hp colonization following the criteria of the Sydney System appears from our study to underestimate the true prevalence of the infection in the stomach when there is mucosal atrophy.

Tissue staining for Helicobacter pylori in intestinal metaplasia: correlation with its extension and histochemical subtypes.

The role played by Helicobacter pylori (Hp) infection in the occurrence of non-cardial gastric adenocarcinoma is suggestive but still debated. This study aimed to evaluate: a) the prevalence of Helicobacter-like organisms in antral bioptic specimens of 291 patients with chronic gastritis with antral atrophy and different subtypes of intestinal metaplasia (IM); b) the presence of a possible different positive tissue staining for the bacteria in the complete and incomplete intestinal metaplasia. Of the 291 patients, 222 cases (76.3%) showed type I IM, 28 cases (9.6%) type II IM and 41 cases (14.1%) type III IM. Helicobacter-like organisms were found in 42.9% of cases and positive tissue staining rate appeared to be inversely related to the extension of IM (58.7% in IM extended in less than 30% of specimens, 30.2% in IM extended between 30% and 60%, 2.7% in IM exceeding 60% of the biopsed area). The inverse correlation between lower positive tissue staining for Helicobacter-like organisms and greater extension of IM was statistically significant (p < 0.001). Incomplete metaplasia appeared to be unrelated to age and associated with a lower positive tissue staining for Helicobacter-like organisms; among patients with type I metaplasia, 118/222 showed Hp-positive bioptic specimens, vs 7/69 of types II and III (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Controlled trial of different dosages of octreotide in the prevention of hyperamylasemia induced by endoscopic papillosphincterotomy.

Pancreatic reaction after endoscopic papillosphincterotomy (EPT) is a common event occurring in about 70% of cases. Acute pancreatitis may also develop in 1%-6% of cases. Previous attempts to prevent this reaction with an inhibitor of exocrine pancreatic secretion such as somatostatin provided conflicting results. The somatostatin long-acting analogue octreotide has recently proposed for the prevention of ERCP/EPT-induced pancreatic reaction. Therefore we tested the prophylactic effect of a subcutaneous administration of octreotide in two different dosages in 60 consecutive patients undergoing EPT for common bile duct stones and benign papillary stenosis. They were given either octreotide 0.2 mg (20 cases), or octreotide 0.1 mg (20 cases), or placebo (20 cases) before the procedure. Serum amylase levels were determined at baseline and 2, 4, 8 and 24 hours thereafter. The differences were statistically significant at 2 hours between subjects pretreated with octreotide 0.2 mg and control subjects (p = 0.01); at 4 and 8 hours after the procedure between both octreotide-treated groups and control subjects (octreotide 0.1 mg: p < 0.05, at 4 and 8 hrs; octreotide 0.2 mg: p = 0.01, at 4 hrs, and p < 0.01, at 8 hrs). In patients with previous episodes of relapsing pancreatitis, the increase in serum amylase was significantly reduced in the octreotide 0.2 mg group vs control group, at 4 hrs (p < 0.05) and 8 hrs (p < 0.05). Our data suggest that octreotide 0.2 mg has a greater prophylactic efficacy than 0.1 mg in reducing pancreatic reaction after EPT.

Combined endoscopic and extracorporeal shock-wave treatment in difficult bile duct stones: early and long-term results.

Endoscopic papillosphincterotomy (EPT) has become a well-established therapeutic procedure in the management of common bile duct stones; however, in difficult cases with large stones or anatomic conditions limiting the amplitude of the sphincteric section, the procedure may fail. In these cases, the association with extracorporeal shock-wave lithotripsy (ESWL) has proved to be helpful. Twenty out of 21 patients in whom the endoscopic approach failed because of the presence of large stones in the biliary tree (15 cases) or anatomic conditions (5 cases) underwent ESWL treatment. Stone fragmentation was achieved in 18 of the 20 treated patients (90%), with spontaneous clearing of the fragments in 10 patients after ESWL sessions and in another 2 patients within three months. In 6 cases the residual fragments were extracted by means of endoscopy. The combined procedures were therefore successful in all the 18 cases in which stone fragmentation was obtained. Complications occurred in two cases after ESWL treatment (asymptomatic pancreatic reaction and severe bleeding from the papillary area). Clinical, ultrasound and biochemical evaluations at 6 and 12 months documented a normal condition in all but two treated subjects.