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Biomedical subjects

R A Kozarek

Publications and source records attributed to R A Kozarek.

At least 19 recordsLinked to original sources

A pancreatic ductal leak should be sought to direct treatment in patients with acute pancreatitis.

BACKGROUND: The end result of leakage of pancreatic juice into the peripancreatic space can be sterile necrosis, infected necrosis, or rupture into an adjacent hollow viscus or blood vessel (eg, colon, small bowel, or pseudoaneurysm). If a pancreatic duct (PD) leak is present, should treatment be aimed at minimizing the sequela of the leakage of pancreatic juice and not just supportive observation until a necrosectomy is required? METHODS: In 144 patients with severe pancreatitis we investigated whether the presence of a PD leak was associated with necrosis and also asked if PD leak might predict other outcomes such as a length of stay (LOS), mortality, and need for surgery. Furthermore, we questioned whether the use of endoscopic retrograde cholangiopancreatography (ERCP) to search for a PD leak might worsen the clinical outcome because of the potential for introducing microorganisms into an undrained space or exacerbating pancreatitis. RESULTS: The presence of a demonstrable pancreatic duct leak was observed in 37% of patients and was significantly associated with both a higher incidence of necrosis and prolonged LOS (> or = 20 days). These patients were 3.4 times more likely to have necrosis and 2.6 times more likely to have a prolonged LOS. When treated with a combination of percutaneous drains, pancreatic duct stents, and surgery as necessary, a PD leak (even with its higher necrosis rate) was not significantly correlated with either mortality or the need for necrosectomy. The use of ERCP was not associated with LOS, mortality, or the need for necrosectomy, provided discovered PD leaks were immediately drained. CONCLUSIONS: A PD leak is common in patients with pancreatic necrosis but it is also important to locate and decompress in order to impede progression of the disease and keep mortality low.

Adult↗

Therapeutic pancreatic endoscopy.

Therapeutic endoscopy in pancreatitis has included biliary or pancreatic sphincterotomy, or both, for microlithiasis and sphincter dysfunction. Alternatively, endoscopic treatment has been used to treat ductal disruption, including external or internal fistulas (high amylase effusions, pancreatic ascites, pancreaticoenteric communications, or pseudocysts). Finally, endoscopy has been used to treat obstructive disease, including both stones and strictures. This article reviews the state of the art in this field over the past year. Unfortunately, this is an area in which the appropriate approaches are still poorly defined, and prospective studies randomly assigning patients to endoscopic treatment in comparison with medical or surgical therapy remain few and far between.

Adolescent↗

In vitro study and in vivo application of a reusable double-channel sphincterotome.

BACKGROUND AND STUDY AIMS: Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) has been deemed to be a "cost-prohibitive" procedure, based upon the cumulative costs of one-time-use accessories and current reimbursement plans. One-time-use sphincterotomes comprise a significant component of that cost and, accordingly, we evaluated the disability and clinical usefulness of a recently introduced reusable double-channel sphincterotome. MATERIALS AND METHODS: We studied a reusable 6-Fr sphincterotome at baseline and following contamination with 10(6) Bacillus stearothermophilus. Reprocessing included a unique 30-minute ultrasonic cleaning step in lieu of manual cleaning, followed by steam sterilization. Parameters evaluated included sphincterotome function, electrical integrity, and our ability to sterilize the devices for three in vitro trials. In vivo studies included patient demographics and outcomes, procedural findings, and success rates, and the mean number of times the sphincterotome was used, functional grading at time of use, and reasons for sphincterotome malfunction. RESULTS: Ten out of ten sphincterotomes maintained form, function, and electrical integrity in vitro, and all cultures were negative after sterilization. In the initial in vivo study, ten sphincterotomes were used in 50 patients (mean, 5 uses) with a 94% success rate. Reasons for sphincterotome failure included leak or breakage of the accessory port in 70%, wire fracture in 10%, incorrect wire bow in 10%, and clogged injection port in 10%. Following reconfiguration of the insertion-port polymer, an additional ten sphincterotomes were used in 110 patients (mean, 11 uses). Mechanical failure occurred primarily at the wire-insertion port, resulting in progressive friction with reuse. There were neither electrical nor infectious complications associated with reuse. CONCLUSIONS: A reusable double-channel sphincterotome is available which can theoretically be reprocessed and sterilized without the manual cleaning step of the reprocessing process. Contingent upon both provider and patient, multiple reuse can be anticipated, and contingent upon purchase price and reprocessing costs, the potential for procedural cost savings is significant.

Cholangiopancreatography, Endoscopic Retrograde↗

Reusable biopsy forceps: a prospective evaluation of cleaning, function, adequacy of tissue specimen, and durability.

BACKGROUND: Recent studies have indicated that reusable biopsy forceps remain contaminated after reprocessing and can only be used a mean of 12 to 25 times without malfunction. Because this contradicts traditional endoscopic practice, our study investigated the ability to sterilize a type of commercially available biopsy forceps and prospectively evaluated their function in vivo until malfunction and/or breakage. METHODS: Thirty reusable biopsy forceps were studied, 15 of which were contaminated for 5 trials each with 10(6) Bacillus stearothermophilus, and 15 of which were prospectively evaluated clinically over an 18-month period (9/98-3/00). Contaminated forceps were reprocessed by using a standard protocol and placed in a sterile bag containing soy broth. The latter was passed through a 0.2 micron filter and was subsequently cultured. In vivo data included biopsy site, size, adequacy, problems obtaining a biopsy specimen, and reasons for ultimate forceps failure. RESULTS: After contamination, all biopsy forceps yielded a heavy growth of B stearothermophilus. No forceps, including 5 that were piecemeal dismantled with a wire cutter, had residual bacteria after reprocessing. In the in vivo study, 1507 biopsy sessions were undertaken in 1339 procedures. Forceps were categorized as new or like-new in 1259 of 1339 (94%) procedures, some loss of function but usable in 72 of 1339 (5.4%), and inadequate function or broken at use in 8 of 1339 (0.6%). Histologically, 1501 specimen sets were adequate (99.6%) and mean specimen size was 2.7 +/- 0.1 mm. Mechanical problems were noted in only 38 of 1507 (3%) sessions to include such things as sticky forceps, and the mean number of uses to malfunction or breakage was 91 +/- 15 (SEM) (range 19-132). CONCLUSIONS: This reusable biopsy forceps can be sterilized and used a mean of 91 times with adequate tissue sampling. Mechanical problems were minor to time of breakage. Contingent on acquisition and reprocessing costs as well as the number of procedures performed, this reusable forceps has the potential for significant cost savings.

Biopsy, Needle↗

Twenty cases of peristomal pyoderma gangrenosum: diagnostic implications and management.

HYPOTHESIS: Our experience with peristomal ulcers suggested that peristomal pyoderma gangrenosum (PPG) is an infrequent and usually unrecognized complication of inflammatory bowel disease. We hypothesized that a review of our experience with PPG would clarify the essentials of its diagnosis, evaluation, and treatment. DESIGN: A case series of 20 consecutive patients with PPG complicating inflammatory bowel disease were treated at our institution between 1986 and 1999. There were 15 women and 5 men. At the time of development of peristomal pyoderma, 10 of 20 patients had a diagnosis of Crohn disease (CD), while 9 had a diagnosis of ulcerative colitis (UC). One patient was diagnosed as having CD only after first developing PPG. MAIN OUTCOME MEASURE: Healing of PPG. INTERVENTIONS: All patients had failed local enterostomal care prior to referral. Debridements and/or stomal revisions were uniformly unsuccessful. Biopsies, when performed, did not provide clinically important information. Treatment was directed toward inflammatory bowel disease, with variable clinical responses to corticosteroids, metronidazole, cyclosporine, sulfasalazine, and infliximab. RESULTS: Ultimately, 13 patients had a diagnosis of CD. Of these patients, 12 (92%) of 13 developed PPG coincident with recurrent disease. Two patients had a remote history of proctocolectomy for UC and subsequent evaluation revealed CD. One patient developed PPG adjacent to a urinary Kock pouch after cystectomy; ultimately, a diagnosis of CD was made. No patients were lost to follow-up, but in 1 case of UC, no evaluation for latent CD was carried out. The final diagnosis was CD disease in 13 (65%) of 20 and UC in 7 (35%) of 20 patients. All PPG ulcers healed completely, within an average of 11.4 months (median, 8 months; range, 1-41 months). Ulcer resolution was achieved with medical therapy alone in 14 (70%) of 20 cases. Resection of active gastrointestinal CD resulted in healing in 5 (83%) of 6 cases. One case healed 2 months after conservative therapy only. CONCLUSIONS: This review of the largest reported series of PPG suggests the following: (1) PPG complicating inflammatory bowel disease is uncommon and often misdiagnosed by clinicians; (2) local wound care measures have little role in the healing of PPG; (3) PPG usually heralds active CD; (4) in patients with prior history of UC, PPG indicates CD until proven otherwise; (5) prolonged medical therapy (11 months), usually with immunosupression, is required for healing of PPG; and (6) if feasible, surgical resection of all active CD leads to the healing of PPG ulcers.

Adult↗

Computed tomography severity index is a predictor of outcomes for severe pancreatitis.

BACKGROUND: In a small group of patients with acute pancreatitis, Balthazar and Ranson demonstrated the applicability of computed tomography (CT) criteria to predict mortality. Building upon their work with a larger group of patients with acute pancreatitis, we set out not only to demonstrate that the CT severity index can predict death, but also length of hospital stay and need for necrosectomy. METHODS: We reviewed all patients admitted to our hospital in the years 1992 to 1997 with a primary diagnosis of acute pancreatitis. Entrance criteria required that a CT scan had been performed during the hospitalization. The index CT scan was used to determine a CT severity index (the CTSI of Balthazar and Ranson). Outcomes measured were death, length of stay (LOS), and need for necrosectomy (NEC). Statistical analysis was performed using Fisher's exact and chi-square tests where appropriate. RESULTS: Between the years 1992 to 1997, 886 patients had 1,774 admissions for acute pancreatitis, of which 268 had a CT scan performed and were entered into our study. These 268 patients had a mean age of 57 years, a mean LOS of 16 days (1 to 118), and a mean CTSI of 3.9 (0 to 10). Overall mortality was 4% (n = 11). A CTSI >5 significantly correlated with death (P = 0.0005), prolonged hospital stay (P <0.0001), and need for necrosectomy (P <0.0001). Patients with a CTSI >5 were 8 times more likely to die, 17 times more likely to have a prolonged hospital course, and 10 times more likely to undergo necrosectomy than their counterparts with CT scores <5. CONCLUSIONS: These data show that the CTSI is an applicable and comparable predictor of outcomes in severe pancreatitis.

APACHE↗

Overview of the problem: reprocessing versus disposal of endoscopic accessories.

The decision to reuse or not reuse endoscopic accessories appears simple on the surface. Further reflection, however, reveals that the decision to purchase reusable accessories or reuse disposable accessories is complex and controversial. This article clarifies key issues surrounding the use of disposable and reusable endoscopic accessories. Discussion includes the advantages and disadvantages of disposable and reusable accessories, the issues surrounding reprocessing of reusable equipment, and the issues surrounding the reuse of disposable accessories.

Disposable Equipment↗

Recurrent pancreatitis in Gardner variant familial polyposis: etiology, diagnostic approach, and interventional results.

HYPOTHESIS: Pancreatitis arising from an obstructing ampullary neoplasm in patients with Gardner variant familial polyposis is an infrequently described clinical entity. We reviewed all patients with Gardner variant polyposis presenting with pancreatitis during a 12-year period in our institution, hoping to better define etiology and the appropriate diagnostic and interventional approach. METHODS: A retrospective record review (1986-1998) defined patient demographics, presenting features, initial and subsequent endoscopic retrograde cholangiopancreatography (ERCP) findings, subsequent treatments, and both immediate and long-term outcomes. Particular consideration was given to initial post-ERCP diagnosis and to endoscopic interventions undertaken at that time. We also looked at those patients who eventually required surgical intervention after long-term failure of medical and endoscopic therapy, the indications for surgery, final pathological characteristics, and follow-up results. RESULTS: Eight patients (6 women and 2 men), with a mean age of 42 years at initial presentation, were found. Each patient was known to have Gardner variant familial polyposis at the time of the initial bout of pancreatitis. All had undergone prior colectomy and 4 of 8 had undergone prior cholecystectomy. None were known to be taking medications or ingesting pancreatoxic substances. Five of 8 patients had obstructing focal or diffuse adenomatous disease involving the ampulla. Two of 8 patients had pancreatitis attributed to other causes (divisum, stones) and a single patient had no clear etiology. Three of 5 patients with ampullary adenomatous disease underwent pancreaticoduodenectomy for recurrent adenomatous encroachment and ampullary stenosis, despite repetitive snare resection and papillotomy. All of these patients had ampullary and other duodenal adenomas, and none had malignant disease. CONCLUSIONS: Patients presenting with pancreatitis in the setting of Gardner variant familial polyposis will frequently have an obstructing ampullary neoplasm, although additional etiologies should be sought. Initial endoscopic therapy affords transient relief but may not be definitive. The abnormal scarring and fibrosis (keloid formation, desmoid reaction) that characterize this disease likely play a large role in endoscopic or subsequent surgical failure. A significant number of these patients will go on to require surgical referral and intervention.

Adult↗

In vitro and in vivo evaluation of a reusable double-channel sphincterotome.

BACKGROUND: To date, one reusable, double-channel sphincterotome has been approved by the Food and Drug Administration in the United States. Whether this device can be reprocessed easily and whether it is more durable than currently manufactured disposable sphincterotomes are uncertain. METHODS: Thirty double-channel, 20 mm, braided-wire sphincterotomes approved for multiple uses were studied in vitro/in vivo with regard to durability and sterilization. A cost analysis of reusable, disposable, and reprocessed disposable sphincterotomes was also carried out. RESULTS: Three of 10 sphincterotomes evaluated in vitro broke after 3, 4, and 8 uses. Electrical integrity was preserved after 10 uses in the remaining sphincterotomes. Nine sphincterotomes remained functional for at least 3 uses, five for 6 uses, and one for 10 uses. Culture results after inoculation demonstrated contamination with surviving organisms after manual cleaning and no growth after ethylene oxide sterilization. Sixty-one procedures were performed in vivo using 20 sphincterotomes (mean number of uses 3.1). No evidence of procedurally related infection occurred with reuse. Cost per use of this reusable sphincterotome was calculated to be $62.98; it became cost effective after 2.2 and 7.9 uses when compared with disposable and reprocessed, disposable sphincterotomes, respectively. CONCLUSIONS: This reusable sphincterotome proved to be safe, easily sterilized, and electrically intact after repeated use. In vivo, however, a progressive loss of function limited the mean number of uses to 3.1. In settings that preclude reuse of reprocessed disposable accessories, this reusable sphincterotome may provide a means to decrease costs associated with endoscopic retrograde cholangiopancreatography.

Cholangiopancreatography, Endoscopic Retrograde↗

Use of a double-channel duodenoscope for diagnostic and therapeutic ERCP.

BACKGROUND: A double-channel duodenoscope has the potential to shorten ERCP procedure time or improve procedure success rates because tasks can be done in parallel through variably situated accessory channels. METHODS: We prospectively evaluated a prototype double-channel duodenoscope in 102 patients, recording findings, procedural success, and potential advantages or problems associated with the instrument. RESULTS: Both channels were used in 79 cases (77%) and a single-channel in the remainder. Ninety-nine percent (101 of 102) of diagnostic and 95% (87 of 92) of therapeutic ERCPs were successful. Instrument advantages included decreased procedure time (23%), cannulation/procedural ease (16%), and miscellaneous (6%). Disadvantages were noted in 15% of the patients and were related to instrument diameter and diameter of the accessory channels. CONCLUSIONS: Additional study of second generation dual-channel duodenoscopes appears warranted.

Bile Duct Diseases↗