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Biomedical subjects

R Kozarek

Publications and source records attributed to R Kozarek.

15 recordsLinked to original sources
PubMed2006

Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results.

BACKGROUND: The purpose of the present study was to assess the long-term safety and durability of effect for endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux disease (GERD). The Plicator (NDO Surgical, Inc., Mansfield, MA) used delivers a transmural suture through the gastric cardia to restructure the antireflux barrier. Published reports have shown the Plicator procedure to be effective in reducing GERD symptoms and medication use at 1 year post-plication. METHODS: Twenty-nine patients with chronic heartburn requiring maintenance daily anti-secretory therapy were treated at five sites. Patients received a single full-thickness plication in the gastric cardia 1cm below the gastroesophageal junction (GE) junction. Re-treatments were not permitted. Patients were evaluated at baseline for GERD symptoms and medication use. Intermediate (12 month) and long-term subject follow-up (median follow-up: 36.4 months; range, 31.2-43.9 months) were completed to evaluate procedure safety and durability of effect. RESULTS: Twenty-nine patients completed the 12-month and 36-month follow-up. All procedure-related adverse events occurred acutely, and no new events were observed during extended follow-up. At 36-months post-procedure, 57% (16/28) of baseline proton pump inhibitor (PPI)-dependent patients remained off daily PPI therapy. Treatment effect remained stable from 12- to 36-months, with 21/29 patients off daily PPI at 12 months compared to 17/29 patients at 36-months. Median GERD- Health Related Quality of Life (HRQL) scores remained significantly improved at 36 months versus baseline off-meds scores (8 versus 19, p < 0.001). In addition, the proportion of patients achieving > or = 50% improvement in GERD-HRQL score was consistent from 12 months (59%) to 36 months (55%). CONCLUSIONS: Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 3-years post-procedure. Treatment effect is stable from 1 to 3 years, and there are no long-term procedural adverse effects.

Abdominal Pain↗
PubMed2001

Self-expanding metal esophageal stent with anti-reflux mechanism.

BACKGROUND: When deployed across the gastroesophageal junction, self-expanding metal esophageal stents can predispose to gastroesophageal reflux. Our aim was to evaluate the efficacy of a self-expanding metal esophageal stent that was modified to prevent gastroesophageal reflux. METHODS: The polyurethane coating of a metal Z-stent was extended beyond its lower end to form windsock-type valve. The anti-reflux property of this stent was studied in vitro by submerging the stent under water and measuring the pressure required to invert the valve. Esophageal acid exposure time was measured in 5 dogs with a standard and the modified stent placed across the gastroesophageal junction. The modified stent was also placed in 11 patients with cancer of the gastroesophageal junction who were prospectively followed. RESULTS: The pressure required to invert the valve was directly proportional to the thickness of the valve membrane (48 +/- 0.4 cm water for a 0.0067-inch thick membrane). Esophageal acid exposure time was significantly less with the modified stent as compared with a standard stent (1% +/- 0.3%, 49% +/- 11%, respectively, p = 0.03). Dysphagia score in patients improved from 3.4 +/- 0.1 to 1.1 +/- 0.2 (p < 0.001). Daytime heartburn and regurgitation scores were less than 1 (score 10 = severe). No patient complained of nocturnal reflux symptoms. Karnofsky performance status scale did not improve significantly. CONCLUSIONS: The efficacy of the modified stent in relieving dysphagia is comparable with a standard stent. It also effectively prevents gastroesophageal reflux.

Aged↗
PubMed2001

Prognostic significance of the labeling of Adnab-9 in pancreatic intraductal papillary mucinous neoplasms.

BACKGROUND: Pancreatic intraductal papillary mucinous neoplasms (IPMN), morphologically resembling colonic adenomas, often have an indefinable malignant potential. We used a monoclonal antibody (MAb) raised against colonic adenomas, Adnab-9, to identify patients with a better prognosis. METHODS: We assessed Adnab-9-labeled sections of these neoplasms from 50 patients, 13 pancreatic adenocarcinomas, and 32 colonic adenomas using standard immunohistochemical techniques. RESULTS: 26% of the IPMNs labeled with Adnab-9 as compared to 0% of pancreatic ductal cancers or surrounding benign tissues, (p < 0.001) and 53% of adenomas (p < 0.025). Labeling in IPMNs was usually seen in the noninvasive epithelium suggesting that Adnab-9 is a premalignant marker in these lesions. Labeling of invasive IPMN's identified a group of patients with a superior overall survival (p = 0.027). CONCLUSION: Adnab-9 labeling-characteristics appear similar for both IPMNs and adenomatous polyps, suggesting that they are analogous lesions. Adnab-9 labeling may also be a useful prognostic marker for invasive intraductal papillary mucinous neoplasms.

Adenocarcinoma, Mucinous↗
PubMed1999

A new form of access for endo-organ surgery. The initial experience with percutaneous endoscopic gastrostomy.

BACKGROUND: Intraluminal gastric surgery provides a new treatment option for various disease processes. This study assesses the safety of a new large-diameter percutaneous endoscopic gastrostomy (PEG) for intraluminal surgery. METHODS: Investigators at six institutions were asked to complete a standard questionnaire to assess the difficulties associated with the assembly and introduction of the PEG, plus intraoperative and postoperative problems related to placement of the device. RESULTS: In terms of assembly; 1.9% of respondents reported difficulty obtaining complete vacuum of the balloon tip, and 3.8% had difficulty fitting the graduated dilator to the balloon-tipped cannula. Difficulties associated with introduction of the PEG included disengagement of the dilator from the balloon-tipped cannula (0%), extraction of the dilator-port assembly (0%), difficult PEG pullout (1.9%), abdominal wall bleeding (0%), and difficult PEG dilator separation (7.5%). Intraoperatively, 7.5% of respondents reported inadequate skin bolster fitting, 1.9% had CO(2) leakage into the peritoneal cavity, 0% had inadvertent PEG extraction, and 0% reported injury to the esophagus, colon, or small intestine. Postoperatively, there was a 9.4% rate of wound infection, a 1.9% rate of gastrocutaneous fistula, and a 1.9% rate of esophageal, colon, or small intestine injury. CONCLUSIONS: The large-diameter PEG is safe and effective for endo-organ surgery. Additional preventive measures for PEG site infection should be investigated.

Adult↗
PubMed1997

Clinical utility of endoscopic retrograde cholangiopancreatography.

BACKGROUND: ERCP is a frequently performed procedure, but its necessity for diagnosis and ability to change management plans are unclear in many cases. METHODS: We prospectively evaluated diagnosis, certainty of diagnosis, and management recommendations, both before and after ERCP, as well as therapeutic maneuvers performed during ERCP, in unselected patients undergoing this procedure. RESULTS: ERCP procedures (1341) were studied at a university hospital, an ERCP referral center, and two community hospitals. Among patients undergoing first-time ERCP, the preceding clinical diagnosis was correct for 64% of those predicted to have bile duct stones, 86% to 89% of those given other biliary diagnoses, and 88% predicted to be normal. In 35% of cases, diagnostic confidence improved substantially after ERCP. Endoscopic therapy was successfully completed in 51%. After ERCP, plans for other invasive procedures changed in 82%: percutaneous biliary studies and open surgical procedures were recommended less often and laparoscopic cholecystectomy more often. Endoscopic therapy and overall clinical utility were most common in patients with cholangitis, jaundice, or bile leaks. CONCLUSIONS: ERCP is particularly helpful for diagnosis of bile duct stones but is less likely to change other diagnoses. The endoscopic therapy commonly carried out during ERCP often changes the treatment plan, leading to fewer surgical and percutaneous interventions in general, but more laparoscopic cholecystectomies.

Bile Duct Diseases↗
PubMed1996

Evaluation of per-procedure equipment costs in an outpatient endoscopy center.

BACKGROUND: As disposable endoscopes become available, we need baseline costs associated with reusable instruments to make financially intelligent choices. Accordingly, we analyzed the per-use cost of several types of gastrointestinal endoscopes at our institution. METHODS: Records of 44 gastrointestinal endoscopes were analyzed. Data defined included purchase price, repair and cleaning expense (labor and materials), and number of uses. The labor cost per-use associated with endoscope cleaning was estimated by taking an average time required to clean an endoscope multiplied by the technician's salary. RESULTS: The average number of years of endoscope use varied from 4.6 to 6.9 years contingent on the type of endoscope. For flexible sigmoidoscopes, the average total cost per use was $8.35, and for colonoscopes the cost was $21.81. For gastroscopes and diagnostic and therapeutic duodenoscopes, costs were $20.99, $49.15, and $45.16, respectively. CONCLUSIONS: (1) Excluding costs associated with the procedure itself (admit-recovery, drugs, disposable equipment, and procedural personnel), total peruse scope cost ranged from a low of $8.35 for the flexible sigmoidoscope to $49.15 for the diagnostic duodenoscope. (2) The most important variables associated with per-use endoscope cost included number of uses, initial purchase price, and repair costs. (3) Techniques such as the above can be used to define per-procedure costs for a particular practitioner or institution.

Costs and Cost Analysis↗
PubMed1995

Presentation and treatment of annular pancreas in an adult population.

OBJECTIVE: To describe a series of adult patients with annular pancreas, their presentation, and treatment modalities. METHOD: A retrospective chart review of patients seen at a multispecialty referral center from 1977 to 1994. RESULTS: Seven adult patients (ages ranging from 33 to 77 yr, four females and three males) presented with various symptoms and signs: abdominal pain (six patients) gastric outlet obstruction (two), pancreatitis (two), pancreatic mass (two), gastric/duodenal ulcer (one), and/or postoperative obstructive jaundice (one). The duration of symptoms ranged from 1 wk to 16 yr before diagnosis (median 18 months). Upper GI radiography was consistent with annular pancreas in two cases, CT scan in two cases (neither of which actually depicted the annulus), and four of six successful endoscopic retrograde cholangiopancreatographies. Three patients were diagnosed during operative procedures. Five of the seven patients required therapeutic operative procedures that included transduodenal sphincteroplasty, duodenojejunostomy, gastrojejunostomy, subtotal gastrectomy, or Whipple procedure. Four of the five had significant symptomatic relief. In one case, endoscopic sphincterotomy and biliary stent placement was therapeutic. CONCLUSIONS: 1) Annular pancreas occasionally presents in the adult population. 2) Although gastric outlet obstruction was seen in two of seven patients, a plethora of additional presentations included pancreatic mass, pancreatitis, peptic ulcer disease, and post-operative obstructive jaundice. 3) Diagnosis of annular pancreas was most commonly suggested by upper GI series or endoscopic retrograde cholangiopancreatography. However, fully 40% of diagnoses required surgery for confirmation. 4) In contrast to the pediatric population in whom gastrojejunostomy or duodenojejunostomy is the treatment of choice, a variety of surgical as well as interventional endoscopic procedures were utilized for effective treatment in adults with annular pancreas.

Aged↗
PubMed1995

Cyclosporin use in the precolectomy chronic ulcerative colitis patient: a community experience and its relationship to prospective and controlled clinical trials. Pacific Northwest Gastroenterology Society.

OBJECTIVE: To define what effect seminal and controlled clinical trials have on practice patterns within a gastroenterological community. To define whether these practice patterns reproduce reported treatment methods and whether results comparable with those reported in such trials are noted within a community practice setting. METHODS: Mailed surveies, with telephone follow-up, were sent to all members of the Pacific Northwest Gastroenterology Society. Respondents were queried regarding cyclosporin use in the precolectomy chronic ulcerative colitis (CUC) patient. Data collected included patient demographics, disease duration and extent, pre-treatment use of steroids, method, dosage, and duration of cyclosporin therapy, side effects, and short-term and subsequent clinical results. RESULTS: Twenty-one percent of 81 respondents had used cyclosporin for precolectomy CUC, approximately one-half using constant infusion and one-half using parenteral bolus therapy. Side effects attributed to the cyclosporin were noted in eight of 30 patients (27%), and acute colectomy was avoided in 17 patients (57%). Subsequent colectomy was required in an additional nine patients (73% total) within a 6-month follow-up period, a significantly higher colectomy rate than that reported in prospective trials. CONCLUSIONS: Potential reasons precluding cyclosporin use within the gastroenterological community may include lack of knowledge about cyclosporin therapy for CUC, lack of opportunity, skepticism, fear of medication side effects, survey sampling error, or treatment philosophy. Potential reasons for failure to duplicate the results reported in controlled trials are more complex but may include inadequate treatment duration the learning curve associated with the use of a new medication, or acceptance of colectomy as the treatment of choice in patients with acutely or chronically debilitating disease.

Adolescent↗
PubMed1992

Bile leak after laparoscopic cholecystectomy. Diagnostic and therapeutic application of endoscopic retrograde cholangiopancreatography.

BACKGROUND: Laparoscopic cholecystectomy, introduced less than 2 years ago, is widely accepted by patients and physicians despite the lack of controlled trials comparing this technology with conventional cholecystectomy. Recent series have described a variable incidence of biliary tract injury with laparoscopic gallbladder removal. The primary interaction of endoscopic retrograde cholangiopancreatography with this technology is usually in the preoperative or postoperative diagnosis and treatment of common bile duct stones. METHODS: During a 12-month period, 597 patients underwent laparoscopic cholecystectomy by 20 general surgeons at six Puget Sound (Wash) hospitals. All patients with symptomatic postoperative biloma diagnosed by abdominal ultrasound or computed tomography with or without endoscopic retrograde cholangiopancreatography, as well as those who had acute bile duct injury diagnosed and repaired at the time of cholecystectomy, were retrospectively reviewed. RESULTS: Three bile duct transections were acutely recognized and treated with hepaticojejunostomy. Fourteen additional patients presented within 7 days with biloma, three of whom were treated with percutaneous drainage alone. Of the remaining 11 patients who underwent endoscopic retrograde cholangiopancreatography, six were noted to have common bile duct injuries; two, bile duct transections; and 3, cystic duct leaks that required a variety of endoscopic or surgical therapies. In all, 17 (2.9%) of 597 patients sustained a bile duct injury and, to date, seven (1.2%) of 597 patients required surgery for such injury. CONCLUSIONS: In a regional setting, laparoscopic cholecystectomy appears to be associated with a higher incidence of bile duct injury than previous reports of open cholecystectomy. Possible explanations include variant anatomy plus failure to obtain an operative cholangiogram, inadequate dissection, injudicious use of cautery or clip placement, inherent limitations of the procedure, or the learning curve associated with a new technology.

Bile↗