A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery.

STUDY DESIGN: A prospective, randomized trial comparing Proceed, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery. OBJECTIVES: To determine the effectiveness and safety of Proceed. SUMMARY OF BACKGROUND DATA: Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration-approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. METHODS: For this study, 127 patients undergoing spinal surgery were randomized into either the treatment or control group after standard surgical means to control bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. RESULTS: Proceed stopped bleeding in 98% of the patients (first bleeding site only) within 10 minutes, as compared with 90% of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97% of the Proceed group, as compared with 71% of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. CONCLUSIONS: A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam-thrombin when used for hemostasis during spinal surgery procedures.

Intraoperative ultrasound (IOUS) is essential in the management of metastatic colorectal liver lesions.

Metastatic tumors to the liver account for the majority of hepatic neoplasms. Improvement in resection has been shown to be beneficial and has remained the treatment of choice, carrying a 5-year survival rate of approximately 20 to 30 per cent. In evaluating candidates for surgery, intraoperative assessment for resectability is a key factor and dictates surgical approach, as well as patient prognosis. Historically, imaging techniques such as CT scan, magnetic resonance imaging, and CT arterial portography (CTAP) have been used in preoperative evaluation. However, the sensitivities of these diagnostic tools have been found to be less than optimal. Intraoperative ultrasound (IOUS) has emerged as an important tool in accurately staging metastatic liver disease with a sensitivity of 98 per cent. From 1994 to 1996, 23 patients have undergone IOUS for evaluation of suspected liver neoplasms in an ongoing prospective study. All patients had colorectal carcinoma. All patients received preoperative CT scan, and 11 patients with positive CT scans had CTAP. Fifteen patients were found to have colorectal metastasis to the liver. Surgical management in 7 of the 15 patients was modified because of the use of IOUS. Two patients were found to have unresectable disease thus abandoning hepatic resection, two were found to have additional lesions undetected by preoperative evaluation and were resected, and in two patients margins of resection were changed. One patient was found to have benign hepatic cysts, and no resection was performed. The use of IOUS modified the management of 44 per cent of our patients with liver metastases. IOUS should be routinely used in patients undergoing liver resection for metastatic liver disease.

Cryosurgery for unresectable primary hepatocellular carcinoma: a case report and review of literature.

Primary liver cancers are a significant cause of both morbidity and mortality. Although surgical resection remains the treatment of choice for these tumors, only 10 to 20 per cent of the primary liver tumors are found to be resectable. Presently, the options for these patients include liver transplantation, cryosurgery, or nonsurgical therapy, such as transarterial chemoembolization. Techniques such as alcohol injection, interstitial radiotherapy, laser hypothermia, and radiofrequency electrodissection have all been attempted with limited success. We present a case of a 68-year-old woman with a 10-year history of liver cirrhosis secondary to chronic active hepatitis C. A lateral segmentectomy was recommended but could not be done due to severe underlying cirrhosis. Cryosurgery aided by intraoperative ultrasonography was performed successfully. The patient developed recurrent disease at 58 months and died with disease at 62 months. Advances in instrumentation and intraoperative ultrasonography are making cryosurgery a viable surgical therapeutic alternative in the management of patients with unresectable hepatocellular carcinoma. The procedure can be performed safely with low morbidity.

Successful outcome in Swan-Ganz catheter-induced rupture of pulmonary artery.

Swan-Ganz catheter-induced pulmonary artery (PA) rupture is rare, with an incidence of 0.016 to 0.2 per cent, but it remains the most dreaded complication in the placement of these catheters with a mortality above 50 per cent. We report two cases of PA rupture after catheter placement. Both patients were managed nonoperatively and without any invasive procedure. They both stopped bleeding after the initial episode and were discharged a few days later. We believe that in the absence of high-risk factors, such as pulmonary hypertension and systemic anticoagulation, PA rupture from a Swan-Ganz catheter can be successfully treated by withdrawal of the catheter and supportive care.

Merkel cell carcinoma: an aggressive malignancy.

Merkel cell carcinoma is a rare and aggressive malignant tumor of the skin. We retrospectively reviewed five patients treated from January 1987 to December 1995. The mean age was 75 years (range, 65-85). There were three primary lesions of the head and neck and two of the extremities. Three were stage II and two were stage III. All primary tumors underwent wide excision with clear margins. Four patients recurred, with a mean time to recurrence of 10 months (range, 2-17). All tumors were positive for immunohistochemical stains (cytokeratin and neuron-specific enolase). Only the two patients who did not have radiotherapy to the primary site had a local recurrence. There was regional recurrence in two of the three patients who had adjuvant radiotherapy to regional lymph nodes. One patient who had a wide excision of the primary lesion, prophylactic lymph node dissection (15 of 34 lymph nodes were positive), and adjuvant chemotherapy is alive and disease free at 23 months. Three patients have died with disease, and two are alive and disease free. Merkel cell carcinoma should be treated aggressively with wide excision of the primary lesion (3-cm margins), and prophylactic lymphadenectomy followed by irradiation to the primary site. If lymph node involvement is detected, then irradiation to the lymph node region must be performed. The role of chemotherapy in this disease is not well defined.