Safety and efficacy of endoscopic spray cryotherapy for esophageal cancer.

Although surgery is traditionally the standard of care for esophageal cancer, esophagectomy carries significant morbidity. Alternative endoscopic therapies are needed for patients who are not candidates for conventional treatment. The objective of this study is to assess the safety, efficacy, and tolerability of spray cryotherapy of esophageal adenocarcinoma. This study includes patients with esophageal adenocarcinoma who had failed or were not candidates for conventional therapy enrolled retrospectively and prospectively in an open-label registry and patients in a retrospective cohort from 11 academic and community practices. Endoscopic spray cryotherapy was performed until biopsy proven local tumor eradication or until treatment was halted due to progression of disease, patient withdrawal or comorbidities. Eighty-eight patients with esophageal adenocarcinoma (median age 76, 80.7% male, mean length 5.1 cm) underwent 359 treatments (mean 4.4 per patient). Tumor stages included 39 with T1a, 25 with T1b, 9 with unspecified T1, and 15 with T2. Eighty-six patients completed treatment with complete response of intraluminal disease in 55.8%, including complete response in 76.3% for T1a, 45.8% for T1b, 66.2% for all T1, and 6.7% for T2. Mean follow-up was 18.4 months. There were no deaths or perforations related to spray cryotherapy. Strictures developed in 12 of 88 patients (13.6%) but were present before spray cryotherapy in 3 of 12. This study suggests that endoscopic spray cryotherapy is a safe, well-tolerated, and effective treatment option for early esophageal adenocarcinoma.

Safety and efficacy of endoscopic spray cryotherapy for Barrett's dysplasia: results of the National Cryospray Registry.

Retrospective series have shown the efficacy of endoscopic spray cryotherapy in eradicating high-grade dysplasia (HGD) in Barrett's esophagus (BE); however, prospective data are lacking, and efficacy for low-grade dysplasia (LGD) is unclear. The aim of this study was to assess the efficacy and safety of spray cryotherapy in patients with LGD or HGD. A multicenter, prospective open-label registry enrolled patients with dysplastic BE. Spray cryotherapy was performed every 2-3 months until there was no endoscopic evidence of BE and no histological evidence of dysplasia, followed by surveillance endoscopies up to 2 years. Primary outcome measures were complete eradication of dysplasia (CE-D) and complete eradication of all intestinal metaplasia (CE-IM). Ninety-six subjects with Barrett's dysplasia (67% HGD; 65% long-segment BE; mean length 4.5 cm) underwent 321 treatments (mean 3.3 per subject). Mean age was 67 years, 83% were male. Eighty patients (83%) completed treatment with follow-up endoscopy (mean duration 21 months). In patients with LGD, rate of CE-D was 91% (21/23) and rate of CE-IM was 61% (14/23). In HGD, CE-D rate was 81% (46/57) and CE-IM was 65% (37/57). In patients with short-segment BE (SSBE) with any dysplasia, CE-D was achieved in 97% (30/31) and CE-IM in 77% (24/31). There were no esophageal perforations or related deaths. One subject developed a stricture, which did not require dilation. One patient was hospitalized for bleeding in the setting of non-steroidal anti-inflammatory drug use. In the largest prospective cohort to date, data suggest endoscopic spray cryotherapy is a safe and effective modality for eradication of BE with LGD or HGD, particularly with SSBE.

Moderate sedation for elective upper endoscopy with balanced propofol versus fentanyl and midazolam alone: a randomized clinical trial.

BACKGROUND AND STUDY AIMS: Balanced propofol sedation (BPS) combines propofol with opiates and benzodiazepines and targets at moderate sedation. Data comparing outcomes of BPS and standard sedation with opiates and benzodiazepines during elective esophagogastroduodenoscopy (EGD) are sparse. The primary end point of this study was to compare, in the recovery area, patient satisfaction with EGD following BPS versus standard sedation. PATIENTS AND METHODS: Prospective, single-blinded randomized trial in 110 outpatients undergoing elective EGD and randomized 1:1 to BPS or standard sedation. Upon full recovery, the primary outcome of patient satisfaction was assessed using a 100-mm visual analogue scale (VAS) (1 = not at all satisfied, 100 = completely satisfied). Sedation recovery times and recall of pain and gagging (1 = none, 100 = severe) were also evaluated using a VAS. RESULTS: The BPS and standard sedation groups were similar regarding American Society of Anesthesiologists (ASA), Mallampati class, age, sex, and body mass index (BMI). Compared with the standard sedation arm, the BPS group exhibited higher median procedural satisfaction (99 vs. 85, P < 0.001), and lower median scores for recall of pain (P < 0.001) and gagging (P < 0.001). BPS resulted in a shorter median recovery time (min) (11 vs. 23, P < 0.001). On multivariable regression analysis, predictors of patient satisfaction included use of propofol, increased age, and higher fentanyl dosage. CONCLUSIONS: BPS targeted to moderate sedation by adequately trained endoscopists results in superior patient satisfaction and shorter recovery times than standard sedation alone during EGD.

Prospective comparison of radial and linear endoscopic ultrasound for diagnosis of chronic pancreatitis.

BACKGROUND AND STUDY AIMS: Linear endoscopic ultrasonography (EUS) is currently favored by many endosonographers for the evaluation of pancreatic pathology. However, radial EUS was used in early studies validating EUS for chronic pancreatitis. Radial and linear EUS have never been compared for the diagnosis of chronic pancreatitis. The aim of this study was to compare radial and linear EUS for the diagnosis of chronic pancreatitis using the secretin-stimulated endoscopic pancreatic function test (ePFT) as the reference standard. PATIENTS AND METHODS: One hundred consecutive patients evaluated for pain of possible pancreatic origin underwent combined radial EUS, linear EUS, and secretin ePFT during a single endoscopic session. EUS images were acquired on videotape and blindly scored by three reviewers. The main outcome measure was diagnostic accuracy. RESULTS: The accuracy of radial EUS and linear EUS (cutpoint > or = 4 criteria) was 84 % and 74 %, respectively. The statistical test for noninferiority was significant ( P < 0.001) suggesting that the accuracy of radial EUS is as good as or superior to linear EUS. The ratio of accuracy (pi (radial)/pi (linear)) was 1.14 (95 % confidence interval [CI] 0.99 to 1.28). No statistically significant differences were found between radial and linear EUS in terms of sensitivity, specificity, or overall discriminative ability (area under receiver operating characteristic curve 0.84 vs. 0.76, P = 0.10). Interobserver variability was similar for radial (Fleiss' kappa = 0.61, 95 %CI 0.43 to 0.79) and linear EUS (kappa = 0.50, 95 %CI 0.28 to 0.72). CONCLUSIONS: The accuracy of radial EUS is as good as linear EUS for the diagnosis of chronic pancreatitis.

Argon plasma coagulation, bipolar cautery, and cryotherapy: ABC's of ablative techniques.

A variety of endoscopic ablation modalities are available for the treatment of Barrett's esophagus. Multiple studies have evaluated the use of argon plasma coagulation, mostly in nondysplastic Barrett's esophagus. Significant variations in technique, end points, and follow-up exist between studies, but in most cases argon plasma coagulation is associated with unacceptable rates of persistent intestinal metaplasia and recurrence after completion of treatment. In addition, serious adverse events including perforation and stricture formation are reported. Multipolar electrocoagulation has been studied less thoroughly, but in prospective trials significant rates of persistent and recurrent intestinal metaplasia have also been reported. Lasers and heater probes have been tried in small numbers. Endoscopic cryotherapy ablation is a relatively new technique with studies focusing on high-grade dysplasia and early-stage cancer in high-risk patients. It has an acceptable safety profile, and early results show response in a significant number of patients in whom other modalities have failed.

Palliation of malignant aerodigestive fistulae with self-expanding metallic stents.

Malignant aerodigestive fistulae are rare but devastating sequelae of thoracic cancers, most commonly associated with esophageal cancer. Survival following development of a malignant aerodigestive fistula is measured in weeks. Palliation is the primary goal of therapy and to this end, we report the use of self-expanding metallic stents (SEMS) as treatment. Between May 1999 and January 2004, 12 patients were treated for malignant aerodigestive fistulae. The underlying diagnosis was esophageal cancer for 10 patients, and non-small cell lung cancer for two others. All patients were symptomatic and fistulae were diagnosed by esophagoscopy in seven, bronchoscopy in two, and esophagram in three. Seven covered Wallstents (seven esophageal) and eight covered Ultraflex (five tracheal and three esophageal) were used. A single stent was placed in eight patients (seven esophageal and one tracheal). Three patients required esophageal and tracheal stents and one patient needed two tracheal stents. General anesthesia was required in 50% of the patients. There were no procedure-related complications. Symptoms were palliated in 100% of patients and oral intake was reinstituted in 42% (5/12). All the patients were discharged from hospital after SEMS placement and one patient returned for an uneventful tracheal stent replacement secondary to mucus impaction 2 months later. SEMS placement is an effective strategy to palliate malignant aerodigestive fistulae. Complications are rare and symptoms are alleviated in most patients.

A randomized prospective trial comparing unsedated esophagoscopy via transnasal and transoral routes using a 4-mm video endoscope with conventional endoscopy with sedation.

BACKGROUND AND STUDY AIMS: Unsedated upper endoscopy is an attractive alternative to conventional sedated endoscopy because it can reduce the cost, complications, and recovery time of the procedure. However, it has not gained widespread acceptance in the United States. A prototype 4-mm-diameter video esophagoscope is available. Our aims were to compare unsedated esophagoscopy using this 4-mm esophagoscope with conventional sedated endoscopy with regard to diagnostic accuracy and patient tolerance, to determine the optimal intubation route (transnasal vs. transoral), and to identify the predictors of tolerance of unsedated endoscopy. PATIENTS AND METHODS: Outpatients presenting for conventional endoscopy were randomized to undergo unsedated esophagoscopy by either the transnasal or the transoral route, followed by conventional endoscopy. The diagnostic findings, optical quality, and patient tolerance scores were assessed. RESULTS: A total of 137 patients were approached and 90 (65.6 %) were randomized to undergo esophagoscopy by the transnasal route (n = 44) or by the transoral route (n = 46) before undergoing conventional esophagoscopy. Patient tolerance of unsedated esophagoscopy was comparable to that of conventional endoscopy. The transnasal route was better tolerated than the transoral route, except with respect to pain, and 93.2 % in transnasal group and 91.3 % in transoral group were willing to have the procedure again. The diagnostic accuracy of endoscopy using the 4-mm video endoscope was similar to that of standard endoscopy. Patients who tolerated the procedure well had lower preprocedure anxiety scores (29 vs. 42.5, P = 0.021) and a higher body mass index (31.5 kg/m2 vs. 28 kg/m2, P = 0.029) than the other patients. CONCLUSIONS: Unsedated esophagoscopy with a 4-mm esophagoscope was well tolerated and has a level of diagnostic accuracy comparable to that of conventional endoscopy. Factors associated with good tolerance of unsedated esophagoscopy were low anxiety levels, high body mass index, and use of the transnasal route. Unsedated endoscopy may be offered to a selected group of patients based on these criteria.

Outcome of adult cardiopulmonary resuscitations at a tertiary referral center including results of "limited" resuscitations.

BACKGROUND: The results of in-hospital resuscitations may depend on a variety of factors related to the patient, the environment, and the extent of resuscitation efforts. We studied these factors in a large tertiary referral hospital with a dedicated certified resuscitation team responding to all cardiac arrests. METHODS: Statistical analysis of 445 prospectively recorded resuscitation records of patients who experienced cardiac arrest and received advanced cardiac life support resuscitation. We also report the outcomes of an additional 37 patients who received limited resuscitation efforts because of advance directives prohibiting tracheal intubation, chest compressions, or both. MAIN OUTCOME MEASURES: Survival immediately after resuscitation, at 24 hours, at 48 hours, and until hospital discharge. RESULTS: Overall, 104 (23%) of 445 patients who received full advanced cardiac life support survived to hospital discharge. Survival was highest for patients with primary cardiac disease (30%), followed by those with infectious diseases (15%), with only 8% of patients with end-stage diseases surviving to hospital discharge. Neither sex nor age affected survival. Longer resuscitations, increased epinephrine and atropine administration, multiple defibrillations, and multiple arrhythmias were all associated with poor survival. Patients who experienced arrests on a nursing unit or intensive care unit had better survival rates than those in other hospital locations. Survival for witnessed arrests (25%) was significantly better than for nonwitnessed arrests (7%) (P =.005). There was a disproportionately high incidence of nonwitnessed arrests during the night (12 AM to 6 AM) in unmonitored beds, resulting in uniformly poor survival to hospital discharge (0%). None of the patients whose advance directives limited resuscitation survived. CONCLUSIONS: Very ill patients in unmonitored beds are at increased risk for a nonwitnessed cardiac arrest and poor resuscitation outcome during the night. Closer vigilance of these patients at night is warranted. The outcome of limited resuscitation efforts is very poor.

A randomized, double blind study of interleukin 10 for the prevention of ERCP-induced pancreatitis.

OBJECTIVES: Inflammatory cytokines are released during acute pancreatitis. Interleukin 10 (IL-10) is a potent antiinflammatory cytokine with immunosuppressive and antiinflammatory activities. IL-10 has been shown to attenuate pancreatitis in an animal model. A double blind, placebo-controlled pilot study was conducted to evaluate the safety and efficacy of low dose IL-10 for the prevention of ERCP-induced pancreatitis. METHODS: Patients were randomized to receive a single i.v. dose of recombinant human IL-10 (8 microg/kg) or a placebo i.v. bolus injection 15 min before the procedure. Pancreatitis was defined as abdominal pain radiating to the back associated with elevated amylase or lipase two or more times the upper limit of normal requiring hospitalization for > or =2 days. Severity of pancreatitis was based on days of hospitalization. RESULTS: Two hundred patients were enrolled (101 IL-10, 99 placebo). No difference in age, gender, degree of pancreatic duct filling, therapeutic intervention, or complication was detected between the two groups. Eleven patients in the IL-10 group and nine patients in the placebo group had pancreatitis (p = 0.65). The median length of hospitalization was 4 days in the IL-10 group and 3 days in the placebo group (p = 0.75). CONCLUSIONS: IL-10 at the 8-microg/kg i.v. dose was not effective in reducing the incidence or severity of ERCP-induced pancreatitis. Further investigations are necessary to determine if manipulation of the cytokine pathway can prevent ERCP-induced pancreatitis.

Role of differential neuroaxial blockade in the evaluation and management of pain in chronic pancreatitis.

OBJECTIVES: Chronic pancreatic pain is difficult to treat. Surgical and medical therapies directed at reducing pain have met with little long-term success. In addition, there are no reliable predictors of response including pancreatic duct diameter. A differential neuroaxial blockade allows characterization of chronic abdominal pain into visceral and nonvisceral pain origins and may be useful as a guide to the treatment. Pain from an inflamed, and scarred pancreas should be visceral in origin. The purpose of our study was to determine the frequency with which patients with chronic pancreatitis have visceral pain and whether our modified differential neuroaxial blockade technique using thoracic epidural analgesia can accurately predict which patients will respond to medical or surgical therapy. METHODS: We retrospectively reviewed the medical records of patients with a firmly established diagnosis of chronic pancreatitis (Cambridge classification, calcifications) who had undergone a differential neuroaxial block for their chronic abdominal pain evaluation. Patient demographics and medical or surgical treatment for pancreatic pain was recorded. Response to therapy was defined by a 50% reduction in pain by verbal response score. RESULTS: A total of 23 patients were identified. Alcohol was the most common etiology for chronic pancreatitis (15 of 23, 55%). Surprisingly, the majority of chronic pancreatitis patients had nonvisceral pain (18 of 23, 78%) and only 22% (5 of 23) had visceral pain by differential neuroaxial block. Four of five patients (80%) with visceral pain responded to therapy, whereas only 5 of 17 (29%) of patients with nonvisceral pain responded. CONCLUSIONS: Surprisingly, patients with chronic pancreatitis commonly have nonvisceral pain. Differential neuroaxial blockade can predict which patients will respond to therapy.

Sedation for colonoscopy using a single bolus is safe, effective, and efficient: a prospective, randomized, double-blind trial.

OBJECTIVE: Practice guidelines call for the careful titration of sedatives and analgesics during endoscopy, with time taken between incremental doses to assess effect. This approach is time-consuming and has never been validated in a prospective trial. The aim of this study was to compare the safety and efficacy of titration, as outlined in practice guidelines, with a single, rapid bolus of sedatives before colonoscopy. METHODS: Consecutive colonoscopy outpatients were randomized to a single, rapid bolus of meperidine and midazolam or to a titration of doses every 3 min until predefined levels of somnolence were achieved. The colonoscopist was not present during sedation and remained blinded as to which technique was used. Supplemental O2 was given for SaO2 <90% on three or more occasions. Total physician time was calculated from the first injection of sedatives to the removal of the colonoscope. Patient assessments of pain and tolerance were obtained at the time of discharge using visual analog scales of 100 mm (0 = excellent and 100 = unbearable). RESULTS: A total of 101 patients were randomized (49 bolus, 52 titration). Demographic features were similar for both groups. Titration required more physician time than did bolus (32.2 min vs 20.1 min, p < 0.001) and was associated with an increased need for supplemental O2 (44% vs 14%, p = 0.002). Mean tolerance scores were similar (titration 16.3 vs bolus 15.3, p = 0.72). CONCLUSIONS: Rapid bolus sedation for colonoscopy saves significant endoscopist time, is associated with less O2 desaturation, and provides equivalent levels of patient comfort. A revision of the guidelines for sedation and analgesia during endoscopy should be considered.

Gastroenterologist-administered propofol for therapeutic upper endoscopy with graphic assessment of respiratory activity: a case series.

BACKGROUND: Traditional methods of sedation and analgesia for advanced endoscopic procedures can be inadequate and frequently prolong recovery room observation. Propofol is a rapidly acting agent that produces an excellent hypnotic state, but its use is typically limited to anesthesiologist-assisted cases because of the inadequacy of current monitoring standards to reliably detect early stages of respiratory depression. METHODS: Ten patients undergoing advanced upper endoscopic procedures (endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, esophageal stent placement) received a propofol infusion under the control of a second qualified gastroenterologist with advanced cardiac life support skills. Graphic assessment of respiratory activity was made by using a sidestream carbon dioxide detecting cannula. Patient satisfaction was measured with a 100 mm visual analog scale. Recovery scores were measured by standardized scoring of discharge criteria. RESULTS: Monitoring with graphic assessment of respiratory activity detected early phases of respiratory depression, resulting in a timely decrease in the propofol infusion without significant hypoxemia, hypercapnia, hypotension, or arrhythmias. Satisfaction scores were extremely high (median score 92 of 100) and 9 of 10 patients met discharge criteria at 15 minutes after discontinuation of the propofol infusion. CONCLUSIONS: With the use of monitoring by graphic assessment of respiratory activity, propofol infusion by a second qualified gastroenterologist for prolonged upper endoscopic procedures is safe and results in high levels of patient satisfaction with rapid recovery times.

Does paclitaxel improve the chemoradiotherapy of locoregionally advanced esophageal cancer? A nonrandomized comparison with fluorouracil-based therapy.

PURPOSE: A phase II trial of accelerated fractionation radiation with concurrent cisplatin and paclitaxel chemotherapy was performed to investigate the role of the paclitaxel, when substituted for fluorouracil (5-FU), in the chemoradiotherapy of esophageal cancer. PATIENTS AND METHODS: Patients with an esophageal ultrasound stage of T(3) or N(1) or M(1) (nodal) esophageal cancer were treated with two courses of a cisplatin infusion (20 mg/m(2)/d for 4 days) and paclitaxel (175 mg/m(2) over 24 hours) concurrent with a split course of accelerated fractionation radiation (1.5 Gy bid to a total dose of 45 Gy). Surgical resection was performed 4 to 6 weeks later followed by a single identical postoperative course of chemoradiotherapy (24 Gy) in patients with significant residual tumor at surgery. Toxicity and results of this treatment were retrospectively compared with our previous 5-FU and cisplatin chemoradiotherapy experience. RESULTS: Between September 1995 and July 1997, 40 patients were entered onto this study. Although dysphagia proved worse in our 5-FU-treated patients, profound leukopenia and a need for unplanned hospitalization were significantly more common in the paclitaxel group. Thirty-seven patients (93%) proved resectable for cure. The 3-year projected overall survival is 30%, locoregional control is 81%, and distant metastatic disease control is 44%. When compared with a similarly staged cohort of 5-FU-treated patients, there was no advantage for any survival function studied. CONCLUSION: This paclitaxel-based treatment regimen for locoregionally advanced esophageal cancer produced increased toxicity with no improvement in results when compared with our previous 5-FU experience. Paclitaxel-based treatments must be carefully and prospectively studied before their incorporation into the standard management of esophageal cancer.

Colonic epithelial lymphocytosis without a thickened subepithelial collagen table: a clinicopathologic study of 40 cases supporting a heterogeneous entity.

Lymphocytic colitis (LC) is classically described as a triad of chronic nonbloody, watery diarrhea, normal or nearly normal endoscopy findings, and colonic epithelial lymphocytosis without a thickened subepithelial collagen table (SECT). It is unknown how often patients with colonic epithelial lymphocytosis without a thickened SECT actually present with this classic triad. Cases diagnosed histologically as lymphocytic or microscopic colitis were reviewed. Criteria for inclusion were the presence of at least 15 surface lymphocytes per 100 epithelial cells and the absence of a thickened SECT (<12 microm). Clinical features and course were recorded by chart review and telephone follow-up. Forty patients met the inclusion criteria, including 25 women and 15 men with a mean age of 63.2 years (range, 25-83 years). Twenty-eight patients had the classic triad and were designated as having classic LC. The other 12 patients fulfilled the histologic criteria but not the clinical or endoscopic criteria for classic LC and were classified as having atypical LC (constipation, five patients; macroscopic colitis at endoscopy, five patients; hematochezia, one patient; and incidental finding, one patient). Clinically, patients with classic LC were predominantly women and had a higher incidence of autoimmune disease (p = 0.03) than did those with atypical LC. Histologically, surface eosinophilia was significantly greater in patients with classic LC (p = 0.04). Twenty patients were using nonsteroidal antiinflammatory drugs at the time of their colonic biopsy. Surface epithelial lymphocyte counts were higher in these patients, particularly in the distal sigmoid colon (p = 0.02). Fourteen patients had associated autoimmune disease, including three patients with sprue diagnosed by small bowel biopsy, all of whom responded to gluten withdrawal. Diarrhea present in 25 patients, without documented evidence of celiac sprue, was self-limited in five, resolved with treatment in three, required intermittent treatment in eight, daily treatment in five, and was refractory to treatment in four. All eight patients who experienced spontaneous or treatment-related symptom resolution had classic LC. No histologic feature correlated with clinical course. In conclusion, our study shows that colonic epithelial lymphocytosis without a thickened SECT is a histologic finding seen in a heterogeneous group of patients. Within this heterogeneous group is a distinct subset of patients who have the classic clinicopathologic triad of LC. This subset of patients has striking similarities to patients with collagenous colitis, lending further support to a close relationship between these two entities. Atypical LC comprises a heterogeneous group and includes patients with idiopathic constipation, coexisting LC and inflammatory bowel disease, and possibly infectious colitides. Because of the clinical heterogeneity among our study population, the descriptive term colonic epithelial lymphocytosis may be a more prudent diagnosis than lymphocytic colitis in the absence of adequate clinical information.

Immunogenicity of hepatitis A vaccine in decompensated liver disease.

OBJECTIVE: Hepatitis A can cause decompensation and death in patients with previous liver injury. The hepatitis A vaccine is recommended for patients with chronic liver disease. The aim of this study was to screen, immunize, and measure the safety and antibody response of the hepatitis A vaccine in liver failure and liver transplant patients. METHODS: This was a prospective immunization trial at a referral center for liver disease and liver transplantation. A total of 193 patients with severe chronic liver disease were screened and 24 patients were vaccinated. Sixteen end stage liver disease patients were compared with eight liver transplant patients. Hepatitis A vaccinations using 1440 ELISA units were given at 0 and 2 months. Serum hepatitis A antibody titers were measured after each vaccine dose. An antibody response > or = 33 mIU/ml was considered protective. RESULTS: Screening seropositive rate was 70 of 193 (36%) and 24 patients were available for vaccination. The median antibody titer was markedly lower in liver transplant patients, 0.0 mIU/ml compared to liver failure patients 34.7 mIU/ml (p < 0.001). Liver transplant recipients did not respond to the vaccine (0 of eight patients) compared with seven of 14 liver failure patients (seroconversion rate 50%, p = 0.02). CONCLUSIONS: Liver failure significantly reduces the antibody response to hepatitis A vaccine, and liver transplant recipients were unable to respond to the vaccine. Although this study was small, immunization should be considered early for susceptible patients with chronic liver disease because the development of liver failure may blunt the immunogenicity of the vaccine.

Sarcoidosis presenting as granulomatous colitis.

Sarcoidosis presenting solely as a granulomatous colitis is rare and appears identical to Crohn's disease. A 56-yr-old woman developed a Crohn's-like illness, which remitted after 5-ASA therapy. Two months later, she developed fever, adenopathy, muscle weakness, and peripheral neuropathy. A diagnosis of sarcoidosis was made after an extensive search for an infectious or rheumatological cause. This case illustrates the utility of serum angiotensin converting enzyme level in differentiating sarcoidosis from Crohn's disease.

Sublingual hyoscyamine for patient comfort during screening sigmoidoscopy: a randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: Screening sigmoidoscopy is an underutilized method for detecting early colorectal cancer, and patient discomfort is one reason for poor compliance in the general population. The possible benefit of a well-tolerated, low-cost antispasmodic medication, sublingual hyoscyamine, used before flexible sigmoidoscopy was assessed in a randomized, double-blinded, placebo-controlled trial. METHODS: One hundred fifty patients were enrolled and randomized to receive two sublingual hyoscyamine tablets (0.125 mg/tablet) or the placebo 10 minutes before sigmoidoscopy. Patient comfort and the endoscopist's perception of the ease of insertion were measured using a 100 mm visual analog scale. The depth of sigmoidoscope insertion was measured in centimeters, and complications were recorded. RESULTS: The median age was 55 years (range 25 to 83 years). There were 100 men (66.7%) and 50 women (33.3%). Approximately half (n = 76, 50.7%) had a prior sigmoidoscopy or colonoscopy. No statistical differences were found between treatment group means for age, gender, pain score, ease of insertion, or depth of insertion. The hyoscyamine group tended to have lower mean pain (32.4 vs. 37.7, p = 0.18) and difficulty (29.9 vs. 33.7, p = 0.31) scores and greater depth of sigmoidoscope insertion (51.3 vs. 47.7, p = 0.07); however, the differences were not statistically significant. The treatment groups differed with a higher percentage of the hyoscyamine group having a previous endoscopy (60.0% vs. 41.3%, p = 0.02); however, no significant differences were detected between mean pain scores as related to treatment when controlling for previous experience with endoscopy (p = 0.31). CONCLUSIONS: In this study, hyoscyamine administered in the sublingual route did not significantly improve patient comfort, ease of insertion, or the depth of sigmoidoscope insertion during screening sigmoidoscopy. The search for alternative methods to improve patient comfort during screening endoscopy should continue.