Charles M. Wilcox

Choice of long-term strategy for the management of patients with severe esophagitis : A cost-utility analysis

BACKGROUND & AIMS Omeprazole has shown remarkable efficacy and safety in the treatment of patients with gastroesophageal reflux disease (GERD); similarly, laparoscopic techniques have allowed less morbidity in patients undergoing fundoplication procedures. Concerns about the long-term cost and safety of both strategies have prompted a debate of their role in long-term management of patients with severe erosive esophagitis. METHODS A cost-utility analysis was performed to compare two strategies: laparoscopic Nissen fundoplication (LNF) vs. omeprazole. A two-stage Markov model was used to obtain cost and efficacy estimates; all estimates were discounted at 3% per year. The time horizon was 5 years. Sensitivity analyses were performed on all relevant variables. RESULTS Both strategies were similarly effective (4.33 quality-adjusted life years per patient), with omeprazole less expensive than LNF (

Declining prevalence of opportunistic gastrointestinal disease in the era of combination antiretroviral therapy.

6053 vs.

ERCP with the overtube-assisted enteroscopy technique: a systematic review

9482 per patient). At 10 years, LNF and omeprazole costs were similar. Efficacy estimates were extremely sensitive to changes in quality of life associated with postoperative symptoms and long-term use of medication. CONCLUSIONS Medical therapy is the preferred treatment strategy for most patients with severe erosive esophagitis. Individuals with a long life expectancy are good candidates for LNF if postoperative morbidity is low and GERD symptoms remain abated for many years.

Prospective endoscopic evaluation for gastrointestinal graft-versus-host disease: determination of the best diagnostic approach.

OBJECTIVE:Opportunistic disorders (OD) are the most frequent GI manifestations of the acquired immunodeficiency syndrome (AIDS). Since the introduction of highly active antiretroviral therapy (HAART), there appears to be have been a reduction in the incidence of many of these OD; however, the effect of HAART on the prevalence of GI OD has not been well studied.METHODS:From 4/95 through 3/98, all HIV (HIV)-infected patients undergoing GI endoscopy were prospectively identified; mucosal biopsies were obtained in a standardized fashion and histological specimens were examined by a single GI pathologist. Patients were divided into three groups based on the time of evaluation: group I: 4/95 to 3/96; group II: 4/96 to 3/97; and group III: 4/97 to 3/98.RESULTS:A total of 166 patients (90% men; mean age 36 ± 10 yr; median CD4 lymphocyte count 62 cells/μl, range 2–884, median viral RNA level 1,357 copies/ml, range undetectable to 7,721,715) underwent 279 upper and/or lower endoscopies during the study period. There were no statistical differences in patients’ demographics and indications for endoscopy although the CD 4 lymphocyte count was higher in group III. The percentage of patients receiving HAART at the time of endoscopy increased from 0% to 57% over the three periods (p < 0.01), and the percentage of patient receiving combination antiretroviral therapy increased from 37% to 82% over the study period (p < 0.01). In contrast, the prevalence of OD decreased from 69% (group I) to 13% (group III) (p < 0.01), whereas the prevalence of non-OD, including a normal endoscopy increased from 31% to 87% (p < 0.01).CONCLUSIONS:GI OD now seem to be an uncommon problem in HIV-infected patients undergoing endoscopy despite a low CD4 lymphocyte count, and this reduction of OD was associated with the use of HAART.

Cytomegalovirus colitis in acquired immunodeficiency syndrome: a clinical and endoscopic study

BACKGROUND AND STUDY AIM Overtube-assisted enteroscopy (OAE) techniques have increased the ability to perform endoscopic retrograde cholangiopancreatography (ERCP) in patients with altered upper gastrointestinal anatomy, such as Roux-en-Y gastric bypass. The aim of this study was to compare the efficacy and safety of OAE-ERCP in patients with different configurations of upper gastrointestinal anatomy. PATIENTS AND METHODS A systematic review was performed following a literature search for papers published between 1966 and August 2013. The following databases were searched: MEDLINE (via PubMed), Embase, Cochrane library, and Scopus. The following end points were analyzed: diagnostic and therapeutic success rates, cannulation success rate, ERCP success rate, type of enteroscopy, types of intervention, complications. RESULTS A total of 23 relevant reports on OAE procedures, including single-balloon, double-balloon, and spiral enteroscopy, were analyzed. Studies included a total of 945 procedures in 679 patients (age 2 - 91 years) who had a variety of postsurgical upper gastrointestinal anatomical configurations. Among patients who underwent Roux-en-Y with gastric bypass, endoscopic success was 80 % and ERCP success was 70 %. In patients who had undergone a Roux-en-Y with either a pancreaticoduodenectomy, pylorus-preserving pancreaticoduodenectomy, or hepaticojejunostomy, endoscopic success was 85 % and ERCP success was 76 %. In patients who had undergone a Billroth II procedure, endoscopic success was 96 % and ERCP success was 90 %. In patients with native papilla who underwent successful endoscopy, cannulation was successful in 90 % of patients compared with 92 % in patients with an anastomosis. Overall ERCP success for all attempts was approximately 74 %. Interventions included sphincterotomy, pre-cut papillotomy, anastomotic stricturoplasty, stone removal, stent insertion, stent replacement, and balloon dilation of stenotic anastomosis. There were 32 major complications among the 945 procedures (3.4 %). CONCLUSION Both endoscopic and ERCP success rates were highest in patients with Billroth II anatomy, followed by those with pancreaticoduodenectomy and Roux-en-Y hepaticojejunostomy; the lowest success rates were in patients with Roux-en-Y gastric bypass. Cannulation rates appeared to be equivalent in patients with both native papilla and biliary-enteric or pancreaticoenteric anastomoses. The diagnostic and therapeutic potential of balloon-assisted ERCP were high and the adverse event rate was low.

Gastrointestinal complications of HIV infection: changing priorities in the HAART era

The best endoscopic diagnostic strategy for gastrointestinal (GI) graft-versus-host disease (GVHD) is unknown. Over a 48-month period, all patients with unexplained diarrhea at risk for acute gastrointestinal GVHD were prospectively identified. Acute GVHD was defined as symptoms and histologic evidence of GVHD occurring within 100 days of transplant or donor lymphocyte infusion (DLI). Colonoscopy was performed with multiple biopsies of the ileum, right colon and rectosigmoid colon. Next, upper endoscopy with duodenal and random gastric biopsies of both antrum and body were performed. All biopsies were evaluated for GVHD by an experienced GI pathologist. Over the study period, 24 patients (mean age 37 years; 62.5% male) were evaluated. The median time from transplantation or DLI was 30.5 days. The biopsy site with the highest yield was the distal colon (82%). A combination of upper endoscopy with sigmoidoscopy and colonoscopy with ileal biopsies were equivalent (∼94%). In patients with diarrhea at risk for GVHD, biopsies of the distal colon had the highest diagnostic yield suggesting the importance of sigmoidoscopy and biopsy. Colonoscopy and ileoscopy or flexible sigmoidoscopy plus upper endoscopy had the highest diagnostic yields.

A Novel Composite Endpoint to Evaluate the Gastrointestinal (GI) Effects of Nonsteroidal Antiinflammatory Drugs Through the Entire GI Tract

BACKGROUND Cytomegalovirus colitis is an important complication of the acquired immunodeficiency syndrome (AIDS), although the clinical and colonoscopic manifestations of this disease have not been systematically characterized. METHODS Patients with AIDS and cytomegalovirus colitis were prospectively identified at two medical centers. The diagnosis of cytomegalovirus disease was based on established endoscopic and histologic criteria. At the time of sigmoidoscopic and/or colonoscopic examination, clinical features were recorded; the location, size, and appearance of all endoscopic abnormalities were documented; and multiple biopsies of any lesions were performed. RESULTS Fifty-six patients were studied. The majority of the patients were homosexual men with severe immunodeficiency (median CD4 lymphocyte count 15/mm3, range 1 to 294/mm3). Chronic diarrhea and abdominal pain were the most frequent clinical manifestations, seen in 45 (80%) and 28 (50%) patients, respectively. Five patients (9%) presented with lower gastrointestinal hemorrhage, three of whom had no antecedent history of diarrhea. The colonoscopic abnormalities could be categorized into three main groups: colitis associated with ulcer (39%), ulceration alone (38%), or colitis alone (20%). Subepithelial hemorrhage was a prominent endoscopic manifestation of disease. Of the 31 patients undergoing colonoscopy to the cecum, in four (13%) endoscopic evidence of disease was limited to the colon proximal to the splenic flexure. CONCLUSIONS Cytomegalovirus colitis in AIDS appears to have variable but stereotypical clinical and colonoscopic manifestations. Distal colitis associated with ulceration is the most common colonoscopic pattern.

Prospective randomized trial evaluating ketamine for advanced endoscopic procedures in difficult to sedate patients.

It has now been some 25 years since the initial description of AIDS. Following these observations, the epidemiology, natural history and manifestations of this disease have been well characterised. Intense investigation has better characterised HIV, resulting in the development of effective drug therapies to arrest disease progression. These multidrug combinations, termed highly active antiretroviral therapy or HAART, can suppress the viral load to the undetectable range and secondarily halt the destruction of CD4 T lymphocytes. This virological response is associated with a marked improvement in survival and absence of the many complications related to immunodeficiency. For patients who respond to HAART, the current emphasis is on treating side effects from the medications as well as treating other non-AIDS-related disorders. However, given the cost and complexities of these regimens, there are many patients who continue to present with the classic manifestations of AIDS, and, especially in the developing world, we will continue to see these patients for years to come.

Erythromycin prior to endoscopy for acute upper gastrointestinal haemorrhage: a cost‐effectiveness analysis

Objective. Nonsteroidal antiinflammatory drugs (NSAID) not only cause damage to the upper gastrointestinal (GI) tract but also affect the lower GI tract. To date, there is no endpoint that evaluates serious GI events in the entire GI tract. The objective of this report is to introduce a novel composite endpoint that measures damage to the entire GI tract — clinically significant upper and lower GI events (CSULGIE) — in patients with NSAID-induced GI damage. Methods. We reviewed the data from largescale, multicenter, randomized, clinical trials on lower GI toxicity associated with NSAID use. The rationale for using CSULGIE as a primary endpoint in 2 ongoing trials — the Celecoxib vs Omeprazole and Diclofenac for At-risk Osteoarthritis (OA) and Rheumatoid Arthritis (RA) Patients (CONDOR) trial and the Gastrointestinal Randomized Events and Safety Open-Label NSAID Study (GI-REASONS) — is also discussed. Results. Previous randomized trials focused primarily on damage to the upper GI tract and often neglected the lower GI tract. The CSULGIE endpoint extends the traditional “perforation, obstruction, and bleeding” assessment of upper GI complications by including events in the lower GI tract (small/large bowel) such as perforation, bleeding, and clinically significant anemia. Conclusion. By providing clinicians with a new, descriptive language for adverse events through the entire GI tract, the CSULGIE endpoint has the potential to become a standard tool for evaluating the GI effects of a range of therapies.

Risk factors associated with a decrease ≥2 g/dL in haemoglobin and/or ≥10% haematocrit in osteoarthritis patients taking celecoxib or a nonselective NSAID plus a PPI in a large randomised controlled trial ( CONDOR )

Background Adequate patient sedation is mandatory for advanced endoscopic procedures such as ERCP and EUS.