Evaluation of a prospective adverse event reporting system in interventional radiology.

AIM: To assess the performance of a prospective adverse event (AE) reporting system. MATERIALS AND METHODS: Four hundred and seventy-one consecutive arterial procedures were performed in 465 patients (median age, 65 years; interquartile range, 54-77; 276 men) over 2 years by four interventional radiologists at a single centre where clinical follow-up was not performed routinely by interventional radiology (IR). AEs were reported prospectively using a radiology information system or in interventional radiologists' electronic records and combined in a departmental listing of adverse events (DLAE). A retrospective medical record review was performed to identify a reference standard list of AEs for this observational cohort study. AEs were graded according to the Society of Interventional Radiology AE classification system. Descriptive statistics were calculated for the performance of the DLAE. A model comparing the rate of reporting of AEs with and without integration of clinical follow-up was tested for significance. RESULTS: Thirty-eight of the 471 (8%) IR procedures had an AE according to the reference standard. The DLAE identified 20/38 (53%) of AEs (K=0.67 [good agreement], 95% confidence interval [CI] agreement=0.53-0.81; p=0.0001; sensitivity 52.6% [95% CI, 36-69%], specificity 100% [95% CI, 99-100%], positive predictive value [PPV] 100%, negative predictive value [NPV] 96 [95% CI, 94.5-97%], accuracy 96% [95% CI, 94-97%]). The performance of the AE reporting system will improve with integration of clinical follow-up (p=0.0015). CONCLUSION: A prospective AE reporting system without clinical integration will not detect all procedure complications.

The clinical utility of CA 19-9 in pancreatic adenocarcinoma: diagnostic and prognostic updates.

CA 19-9 and CEA are the most commonly used biomarkers for diagnosis and management of patients with pancreatic cancer. Since the original compendium by Steinberg in 1990, numerous studies have reported the use of CA 19-9 and, to a lesser extent, CEA in the diagnosis of pancreatic cancer. Here we update an evaluation of the accuracy of CA 19-9 and CEA, and, unlike previous reviews, focus on discrimination between malignant and benign disease instead of normal controls. In 57 studies involving 3,285 pancreatic carcinoma cases, the combined sensitivity of CA 19-9 was 78.2% and in 37 studies involving 1,882 cases with benign pancreatic disease the specificity of CA 19-9 was 82.8%. From the combined analysis of studies reporting CEA, the sensitivity was 44.2% (1,324 cases) and the specificity was 84.8% (656 cases). These measurements more appropriately reflect the expected biomarker accuracy in the differential diagnosis of patients with periampullary diseases. We also present a summary of the use of CA 19-9 as a prognostic tool and evaluate CA 19-9 diagnostic and prognostic utility in a 10-year, single institution experience.

Lessons learned from laparoscopic treatment of gastric and gastroesophageal junction stromal cell tumors.

BACKGROUND: Stromal cell tumors of the gastric and gastroesophageal junction are rare neoplasms that traditionally have been resected for negative margins using an open approach. This study aimed to evaluate the efficacy laparoscopic resection of gastric and gastroesophageal stromal cell tumors and the lessons learned from experience with this method. METHODS: This retrospective review evaluated all patients who underwent laparoscopic resection of gastric or esophageal stromal cell tumors at a tertiary referral center between December 2002 and March 2005. Medical records were reviewed with regard to patient demographics, preoperative evaluation, operative approach, tumor location and pathology, length of operation, complications, and length of hospital stay. RESULTS: A total of 12 consecutive patients with a mean age of 55 +/- 5.9 years were treated. Preoperative endoscopic ultrasound (EUS) was performed for 11 of 12 patients with a diagnostic accuracy of 100%, whereas EUS-guided fine-needle aspiration was performed for 10 of 12 patients with a diagnostic accuracy of 50%. Four patients with symptomatic gastroesophageal junction leiomyomas were treated with enucleation and Nissen fundoplication. Eight patients were treated with laparoscopic wedge resection of gastric lesions. Complete R0 resection was achieved for all the patients undergoing laparoscopic resection. Intraoperative endoscopy was performed for four patients and resulted in shorter operative times. The average operative time for this entire series was 169 +/- 17 min: 199 +/- 24 min for the first six cases and 138 +/- 19 min for the last six cases. The median hospital length of stay was 2 days. One patient with esophageal leiomyoma had persistent dysphagia at the 12-month follow-up assessment. There were no other complications and no deaths in this series of patients. CONCLUSIONS: Laparoscopic resection of gastric and gastroesophageal junction stromal cell tumors may be performed safely with low patient morbidity. This approach can achieve adequate surgical margins and lead to short hospital stays. Improvements in the technique have led to shorter operative times.

Malignant islet cell tumor with sarcomatous differentiation.

Malignant mesenchymal neoplasms of the pancreas are rare and malignant islet cell tumors with sarcomatous dedifferentiation are rarer still. We present a case of malignant islet cell tumor with sarcomatous differentiation, which to our knowledge is only the second reported case showing such a combination of morphologic features. Clinically, the neoplasm was not hormonally active and immunohistochemical staining was negative for gastrin, glucagon, insulin and somatostatin. The sarcomatous component strongly reacted with an antibody directed against vimentin, and a minority of cells stained strongly with antisera directed against desmin and smooth muscle actin. The spindle cell component was nonreactive with antibodies directed against Factor VIII. The myogenous direction of differentiation in the present tumor is similar to that seen in the prior case report of malignant islet cell tumor with rhabdomyosarcomatous differentiation.

Safety and timing of nonobstetric abdominal surgery in pregnancy.

BACKGROUND/AIMS: Abdominal disorders occurring during pregnancy pose special difficulties in diagnosis and management to the obstetrician and surgeon. The advisability of nonobstetric abdominal surgery during pregnancy is uncertain. Our objective was to evaluate the safety and timing of abdominal surgery during pregnancy. METHODS: We retrospectively reviewed 77 consecutive gravid patients undergoing nonobstetric abdominal surgery from 1989 to 1996 at an urban academic medical center and a large affiliated community teaching hospital. Medical records were evaluated for clinical presentation, perioperative management, preterm labor, and maternal and fetal morbidity and mortality. RESULTS: The rate of nonobstetric abdominal surgery during pregnancy was 1 in every 527 births. Among the 77 patients, the indications for surgery were adnexal mass (42%), acute appendicitis (21%), gallstone disease (17%) and other (21%). There was no maternal or fetal loss or identifiable neonatal birth defect. Preterm labor occurred in 26% of the second-trimester patients and 82% of the third-trimester patients. Preterm labor was most common in patients with appendicitis and after adnexal surgery. Preterm delivery occurred in 16% of the patients, but appeared to be directly related to the abdominal surgery in only 5%. CONCLUSION: Surgery during the first or second trimester is not associated with significant preterm labor, fetal loss or risk of teratogenicity. Surgery during the third trimester is associated with preterm labor, but not fetal loss.

Laparoscopic hernia repair and bladder injury.

BACKGROUND: Bladder injury is a complication of laparoscopic surgery with a reported incidence in the general surgery literature of 0.5% and in the gynecology literature of 2%. We describe how to recognize and treat the injury and how to avoid the problem. CASE REPORTS: We report two cases of bladder injury repaired with a General Surgical Interventions (GSI) trocar and a balloon device used for laparoscopic extraperitoneal inguinal hernia repair. One patient had a prior appendectomy; the other had a prior midline incision from a suprapubic prostatectomy. We repaired the bladder injury, and the patients made a good recovery. CONCLUSION: When using the obturator and balloon device, it is important to stay anterior to the preperitoneal space and bladder. Prior lower abdominal surgery can be considered a relative contraindication to extraperitoneal laparoscopic hernia repair. Signs of gas in the Foley bag or hematuria should alert the surgeon to a bladder injury. A one- or two-layer repair of the bladder injury can be performed either laparoscopically or openly and is recommended for a visible injury. Mesh repair of the hernia can be completed provided no evidence exists of urinary tract infection. A Foley catheter is placed until healing occurs.

Safety and feasibility of injection with an E1B-55 kDa gene-deleted, replication-selective adenovirus (ONYX-015) into primary carcinomas of the pancreas: a phase I trial.

Novel therapies are needed for locally advanced pancreatic carcinoma. ONYX-015 (dl1520) is an E1B-55 kDa region-deleted adenovirus that selectively replicates in and lyses tumor cells with abnormalities in p53 function (eg gene mutation). We carried out a phase I dose escalation study of ONYX-015 in patients with unresectable pancreatic cancer. ONYX-015 was administered via CT-guided injection (n = 22 patients) or intraoperative injection (n = 1) into pancreatic primary tumors every 4 weeks until tumor progression. Interpatient dose escalation was carried out with at least three patients per dose level from 10(8) p.f.u. up to the 10(11) p.f.u. dose level (two patients treated at this dose). The majority of patients had abnormally low cellular immunity (CD4 counts and hypersensitivity skin testing). Injection of ONYX-015 into pancreatic carcinomas was well-tolerated. Mild, transient pancreatitis was noted in only one patient. Dose-escalation proceeded to the highest dose level. Neutralizing antibodies rose post-treatment in all patients. After injection, ONYX-015 was detectable in the blood 15 min later, but not between 1 and 15 days later. Viral replication was not documented, however, in contrast to trials in other tumor types. No objective responses were demonstrated. Intratumoral injection of an E1B-55 kDa region-deleted adenovirus into primary pancreatic tumors was feasible and well-tolerated at doses up to 10(11) p.f.u. (2 x 10(12) particles), but viral replication was not detectable.

The spectrum and cost of complicated gallstone disease in California.

HYPOTHESIS: We hypothesized that complications of gallstone disease are more common than previously recognized and are related to treatment delay. DESIGN: Retrospective review. PATIENTS: Data for 248 consecutive patients from a university hospital in 1995-1996 and 40,571 patients identified through the 1996 California Office of Statewide Health Planning and Development database who underwent cholecystectomy for gallstone disease were reviewed. MAIN OUTCOME MEASURES: Diagnosis, length of hospital stay, hospital mortality, type of admission, type of surgical procedure, hospital cost, and interval of delay between onset of initial symptoms, ultrasound diagnosis, and cholecystectomy. RESULTS: The spectrum of gallstone disease included biliary colic in 56%, acute cholecystitis in 36%, acute pancreatitis in 4%, choledocholithiasis in 3%, gallbladder cancer in 0.3%, and cholangitis in 0.2%. Community hospitals, public or county hospitals, and academic health centers had a similar distribution of diagnoses. Patients undergoing cholecystectomy for biliary colic had a significantly shorter length of hospital stay, lower operative mortality rate, were more likely to have their operations completed laparoscopically, and had lower hospital charges than patients undergoing cholecystectomy for complications such as acute cholecystitis. Over half of the patients requiring cholecystectomy for complications of gallstones initially presented with biliary colic. Patients with gallstone complications had an average delay from ultrasound confirmation to surgery of 6 months. CONCLUSION: Complications of gallstone disease are (1) common, (2) costly, and (3) potentially preventable.

Does the participation of a surgical trainee adversely impact patient outcomes? A study of major pancreatic resections in California.

BACKGROUND: Some patients have concerns regarding the impact of surgical trainees on the quality of care that they receive in teaching hospitals. No population-based data exist that describe outcomes of surgical procedures in teaching and nonteaching hospitals; however, institutional data suggest that teaching hospitals provide high-quality care. We hypothesized that the presence of a general surgery residency program (GSRP) is associated with superior outcomes for pancreatic resection, a complex surgical procedure. METHODS: A retrospective, population-based, risk-adjusted analysis of 5696 patients who underwent major pancreatic resection compares the outcomes of patients treated at hospitals with a GSRP (GSRP+) and those hospitals without a GSRP (GSRP-). RESULTS: GSRP+ hospitals had a lower operative mortality rate (8.3% vs 11.0%; P <. 001), a lower percentage of patients discharged to another acute care hospital or skilled nursing facility (6.5% vs 13.0%; P <.001), and a longer length of stay compared with GSRP- hospitals (22.1 +/- 0.4 days vs 19.6 +/- 0.3 days; P <.001). The observed difference in hospital mortality rates was not significant after an adjustment was made for patient mix and hospital volume (9.7% vs 10.0%). However, superior outcomes were found in the university teaching hospitals, as compared with the affiliated teaching and the nonteaching hospitals (5.3% [P <.001] vs 11.4% vs 11.0%; risk adjusted, 8.0% [P <.05] vs 10.9% vs 10.0%). CONCLUSIONS: The presence of surgical trainees does not have an adverse impact on the quality of care for One complex procedure, pancreatectomy, and is associated with superior operative mortality rate in university teaching hospitals.

The relationship between hospital volume and outcomes of hepatic resection for hepatocellular carcinoma.

BACKGROUND: Volume-outcome relations have been established for several complex therapies. However, few studies have examined volume-outcome relations for high-risk procedures in general surgery, such as hepatectomy for hepatocellular carcinoma (HCC). OBJECTIVE: To evaluate the relation between hospital volume and outcome for patients undergoing hepatectomy for HCC. DESIGN: Retrospective cohort study. SETTING: All acute-care hospitals in California. PATIENTS: Hospital discharge data were analyzed for each patient in California who underwent major hepatic resection for HCC from January 1, 1990, through December 31, 1994. Hospitals were grouped according to number of hepatectomies performed at each center during the 5-year study. MAIN OUTCOME MEASURES: Outcome measures included operative mortality and length of hospital stay. Regression analyses were used to adjust for differences in patient mix. RESULTS: Five hundred seven patients underwent hepatectomy for HCC during the study. Hepatic resections were performed in 138 hospitals, with an overall in-hospital mortality rate of 14.8%. Three quarters of patients were treated at hospitals that average 3 or fewer hepatic resections for HCC per year. These low-volume providers represent 97.1% of all hospitals treating patients with HCC statewide. Significant reductions in risk-adjusted operative mortality rates (22.7%-9.4%; P = .002, multiple logistic regression) and risk-adjusted length of stay (14.3-11.3 days; P = .03, multiple linear regression) were observed as hospital volume increased. CONCLUSIONS: Low operative mortality and length of stay were associated with high-volume centers. These data support regionalization of high-risk procedures in general surgery, such as hepatectomy for HCC.

Laparoscopic splenectomy.

Splenectomy is a powerful tool for treatment of hematologic disease, with 70% to 90% of patients achieving long-term improvement. In recent years laparoscopic splenectomy has gained acceptance as a viable alternative to open splenectomy. This review summarizes the indications for laparoscopic splenectomy, the operative techniques, and the most recent results. Laparoscopic splenectomy is evolving and may become the standard operative method for the treatment of the problem spleen.

Percutaneous management of abscess and fistula following pancreaticoduodenectomy.

PURPOSE: To evaluate the efficacy of percutaneous drainage of fluid collections following pancreaticoduodenectomy (Whipple's procedure). METHODS: We performed a retrospective review of 19 patients referred to our service with fluid collections following pancreaticoduodenectomy. The presence of associated enteric or biliary fistulas, the route(s) of access for image-guided drainage, the incidence of positive bacterial cultures, and the duration and success of percutaneous management were recorded. RESULTS: Fistulous communication to the jejunum in the region of the pancreatico-jejunal anastomosis was demonstrable in all 19 patients by gentle contrast injection into drainage tubes. Three patients had concurrent biliary fistulas. In 18 of 19 patients, fluid samples yielded positive bacterial cultures. Successful percutaneous evacuation of fluid was achieved in 17 of 19 patients (89%). The mean duration of drainage was 31 days. CONCLUSION: Percutaneous drainage of abscess following pancreaticoduodenectomy is effective in virtually all patients despite the coexistence of enteric and biliary fistulas.

Hepatocyte growth factor stimulates fetal gastric epithelial cell growth in vitro.

BACKGROUND: The growth and development of the fetal gastrointestinal tract is likely mediated, in part, by peptide growth factors. We compared the mitogenic effects of graded doses of hepatocyte growth factor (HGF) to epidermal growth factor (EGF), transforming growth factor-alpha (TGF-alpha), and insulin-like growth factor-1 (IGF-1) on fetal rabbit gastric epithelial cells. MATERIALS AND METHODS: Fetal rabbit gastric epithelial cells were purified by mechanical dissociation and selected culture and grown in short-term (24 h) and long-term (12 days) culture. Stimulation of fetal gastric epithelial cell growth in response to individual peptide growth factors was measured by [3H]thymidine incorporation and cell counting. RESULTS: In short-term culture, HGF stimulated [3H]thymidine incorporation in a dose-dependent manner from a threshold at 10 pM to a maximum at 100 pM. For EGF and TGF-alpha, maximal stimulation occurred at 100 pM. For HGF, maximal [3H]thymidine incorporation was 3.6 +/- 0.7 times basal. For EGF and TGF-alpha, maximal [3H]thymidine incorporation was 4.3 +/- 0.4, and 3.6 +/- 0.4 times basal, respectively. For IGF-1, maximal [3H]thymidine incorporation was only 70% of the maximal effect observed for the other growth factors tested. Rabbit amniotic fluid increased [3H]thymidine uptake in a dose-dependent manner. In long-term culture, purification to greater than 90% epithelial cells was attained after 12 days treatment. For HGF, EGF, TGF-alpha, and 20% rabbit amniotic fluid, significant increases in cell number above control (P < 0.05) were observed at 1 nM concentrations. None of these individual factors, however, increased cell growth as significantly as that of 10% fetal bovine serum. CONCLUSIONS: Our results suggest that: (1) HGF stimulates [3H]thymidine uptake and cell proliferation in fetal rabbit gastric epithelial cells in vitro, and (2) HGF's mitogenic effect on fetal rabbit gastric epithelial cell growth is comparable to that observed for EGF and TGF-alpha, but superior to the effect observed for IGF-1.

Changing management of gallstone disease during pregnancy.

BACKGROUND: Symptomatic gallstones may be problematic during pregnancy. The advisability of laparoscopic cholecystectomy (LC) is uncertain. The objective of this study is to define the natural history of gallstone disease during pregnancy and evaluate the safety of LC during pregnancy. METHODS: Review of medical records of all pregnant patients with gallstone disease at the University of California, San Francisco, from 1980 to 1996. RESULTS: Of approximately 29,750 deliveries, 47 (0.16%) patients were treated for gallstone disease, including biliary colic in 33, acute cholecystitis in 12, and pancreatitis in two. Conservative treatment was attempted in all patients but failed in 17 (36%) cases. Two patients required combined preterm Cesarean-section cholecystectomy and 10 required surgery in the early postpartum period for persistent symptoms. Seventeen patients required cholecystectomy during pregnancy for biliary colic (10), acute cholecystitis (six), and pancreatitis (one). Three patients were treated with open cholecystectomy. Fourteen patients underwent LC at a mean gestational age of 18.6 weeks, mean OR time of 74 min, and mean length of stay of 1.2 days. Hasson cannulation was utilized in 11 patients. Reduced-pressure pneumoperitoneum (6-10 mmHg) was used in seven patients. Prophylactic tocolytics were used in seven patients, with transient postoperative preterm labor observed in one. There were no open conversions, preterm deliveries, fetal loss, teratogenicity, or maternal morbidity. CONCLUSIONS: In past years, symptomatic gallstones during pregnancy were managed conservatively or with open cholecystectomy. LC is a feasible and safe method for treating severely symptomatic patients.

Laparoscopic repair of paraesophageal hiatal hernias.

BACKGROUND: Regardless of symptoms, paraesophageal hiatal hernias should be repaired in order to prevent complications. This study reports the University of California San Francisco experience with laparoscopic repair of paraesophageal hiatal hernias, emphasizing the technical steps essential for good results. PATIENTS AND METHODS: From May 1993 to September 1997, 55 patients, 27 women and 28 men, with a mean age of 67 years (range, 35-102 years) underwent laparoscopic repair of paraesophageal hernias at the University of California San Francisco. Symptoms, which had been present an average of 85 months before surgery, consisted mainly of pain (55%), heartburn (52%), dysphagia (45%), and regurgitation (41%). Of the four patients who presented with acute illness, two had gastric obstruction, one had severe dyspnea, and one had gastric bleeding. Endoscopy demonstrated esophagitis in 25 (69%) of 36 patients, and 24-hour pH-monitoring demonstrated acid reflux in 22 (67%) of 33 patients. Manometry detected severely impaired distal esophageal peristalsis in 17 (52%) of 33 patients. The preferred operation consisted of reduction of the hernia, excision of the sack and the gastric fat pad, closure of the enlarged hiatus without mesh, and construction of a fundoplication anchored by sutures within the abdomen. RESULTS: Of the 55 patients, the operations of 49 were completed laparoscopically using the following reconstructions: Guarner (270-degree) fundoplication (30 patients); Nissen fundoplication (10 patients); and gastropexy (9 patients). Five (9%) operations were converted to laparotomies. The average operating time was 219 minutes; the average blood loss was less than 25 mL; resumption of an unrestricted diet, 27 hours; and mean hospital stay, 58 hours. Intraoperative technical complications occurred in five (9%) patients. One patient died during surgery from a sudden pulmonary embolus. Two (4%) patients required a second operation for recurrent paraesophageal hernias. CONCLUSIONS: Laparoscopic repair of paraesophageal hiatal hernias is safe and effective, but the operation is difficult and good results hinge on details of the operative technique and the surgeon's experience. In this series, the crus could always be closed securely without using mesh. We realized early that a fundoplication should be a routine step, because it corrects reflux and is the best method to secure the gastroesophageal junction in the abdomen.

Prognostic factors in pancreatic carcinoma.

Pancreatic cancer is a relatively common malignancy. Its gravity is underscored by the low overall cure rates. A number of clinical, pathologic, and molecular factors have been identified that predict survival of patients with this neoplasm. These factors are reviewed and analyzed.

Comparison of laparoscopic total and partial fundoplication for gastroesophageal reflux.

Approximately 25% of patients with gastroesophageal reflux severe enough to be considered for surgical treatment have dysfunction of esophageal peristalsis in addition to dysfunction of the lower esophageal sphincter. A standard total (i.e., Nissen) fundoplication in these patients may be followed by dysphagia, so many experts recommend a partial fundoplication as an alternative. The goal of this study was to compare the clinical results and changes in esophageal function following laparoscopic total and partial fundoplication. Ninety-three patients with gastroesophageal reflux disease had laparoscopic antireflux operations. Total fundoplication was performed in 50 patients with normal esophageal peristalsis. Partial fundoplication was chosen for 43 patients with severe abnormalities of esophageal peristalsis. The same percentage of patients has resolution of heartburn (93%) and regurgitation (97%) after partial as compared to total fundoplication. Dysphagia developed in four patients (8%) after total fundoplication (one patient required dilatation) and in no patients after partial fundoplication. Both operations produced similar changes in lower esophageal sphincter function, but only partial fundoplication was associated with improvement in esophageal dysfunction. Esophageal acid exposure became normal in 92% of patients after total and in 91% of patients after partial fundoplication. Partial fundoplication improves lower esophageal sphincter pressure and esophageal body function and, in patients with abnormal esophageal peristalsis, it corrects reflux without producing dysphagia. Partial and total fundoplication are both indicated in patients with gastroesophageal reflux disease, and the choice of which procedure to use should be based on each patient"s specific esophageal motor function abnormalities.

Partial fundoplication for gastroesophageal reflux.

BACKGROUND: About 20% of patients with gastroesophageal reflux disease (GERD) have severely impaired esophageal peristalsis in addition to an incompetent lower esophageal sphincter. In these patients a total fundoplication corrects the abnormal reflux, but it is often associated with postoperative dysphagia and gas bloat syndrome. We studied the efficacy of partial fundoplication in such patients. METHODS: A partial fundoplication (240 degrees -270 degrees ) was performed laparoscopically in 26 patients (11 men, 15 women; mean age 50.5 years) with GERD (mean DeMeester score: 92 +/- 16) in whom manometry demonstrated severely abnormal esophageal peristalsis. RESULTS: All operations were completed laparoscopically and the patients were dicharged an average of 39 h after surgery. The preoperative symptoms resolved or improved in all patients, and no patient developed dysphagia or gas bloat syndrome. Postoperative pH monitoring showed complete or nearly complete resolution of the abnormal reflux in every patient. CONCLUSIONS: Partial fundoplication is an excellent treatment for patients with GERD and weak peristalsis, for it corrects the abnormal reflux and avoids postoperative dysphagia.