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.

Hepatic resection at a community hospital.

Hepatic resection remains the "gold standard" in the primary management of primary and metastatic tumors to the liver. Advanced surgical techniques along with more modern and sophisticated equipment have led to an increasing number of hepatic resections being performed with a concomitant decrease in morbidity and mortality. We followed prospectively 18 consecutive hepatic resections performed over a period of approximately 2.5 years. The setting was a community teaching hospital with a low volume of referrals for hepatic resection. Sixteen (88%) had metastatic disease and two had primary liver disease. There were four trisegmentectomies, four lobectomies, four segmentectomies, and six large wedge re-sections. Average estimated blood loss was 608 ml. Seven patients required transfusions. Complications occurred in five patients (27%). In-hospital mortality was 0%. Our experience suggests that liver resections in a low-volume community hospital can be performed safely provided an experienced surgical team with familiarity of advanced surgical techniques and sophisticated equipment used in hepatic resection is readily available.

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.

Minimally invasive parathyroidectomy utilizing a gamma detecting probe intraoperatively.

The most common pathologic finding in primary hyperparathyroidism is a single adenoma. Traditionally, all four glands have been explored during surgery for primary hyperparathyroidism. With the advent of accurate localizing diagnostic studies, such as the sestamibi scan, some surgeons are now recommending single-gland exploration. In addition, when a sestamibi scan is performed the day of surgery, a gamma detecting probe can be used intraoperatively to direct the dissection. Although an experienced surgeon will successfully locate the abnormal gland 95% of the time with the traditional approach, this new technique results in a smaller incision with better cosmetic results as well as decreased operative time. Our initial experience with eight cases utilizing this technique is presented.

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.

Use of gamma detecting probe and isosulphan blue to localize sentinel node in patients with malignant melanoma.

Elective lymph node dissection for patients with malignant melanoma remains controversial. Sentinel lymph node sampling has been recommended to select patients who will benefit from lymphadenectomy. Vital blue dye and a gamma detecting probe have been used to identify the sentinel node. Two patients are described in whom microscopic disease was identified in the sentinel node as the sole focus of metastasis. The ability to excise the sentinel node provides accurate pathologic and staging information, is cost effective, and minimizes the morbidity associated with a routinely performed lymphadenectomy.

Management of primary and metastatic tumors to the liver.

Primary and metastatic liver tumors continue to be a significant health problem in the United States. Hepatic resection or, in selected cases, transplantation are the only curative therapies for patients with resectable disease confined to the liver. Careful preoperative selection is crucial to avoid unnecessary surgical explorations that considerably reduce the quality of the short remaining life of patients with unresectable tumors. The surgeon needs to understand the role of imaging techniques in the evaluation of hepatic tumors for better selection of the patients who are candidates for an aggressive surgical approach. Several other therapeutic options are available for patients with unresectable disease. Until further research delineates the specific interactions among environmental factors, hepatic injury, hepatic regeneration, host factors, and molecular mechanisms of malignant transformation that can lead to specific preventive and treatment interventions, control of this disease will continue to rely on modifications of currently available treatment modalities.