Surgical innovation and its evaluation.

Early clinical trials, observational or randomized, hasten the prompt evaluation of new operations. Early clinical surveillance facilitates the design and implementation of randomized clinical trials when they are necessary. Of equal or greater importance, long-term surveillance of operations allows continuing evaluation when their use becomes widespread. Standards, coordination, review, and funding of the evaluation of new operations we believe should be centralized in a single national agency, for which an Institute of Health Care Assessment might be created. Implementation and regulation of the evaluation we believe should remain at the local or regional level with existing mechanisms and agencies being used, such as institutional human research committees and local health systems agencies.

Biliary tract obstruction secondary to cancer: management guidelines and selected literature review.

Malignant biliary tract obstruction (MBTO) due to either primary biliary tract cancer or metastasis to the porta hepatis is a common clinical problem. The most common metastatic tumors causing MBTO in order of frequency are gastric, colon, breast, and lung cancers. Radiographic diagnostic procedures should proceed in a cost-effective sequence from ultrasonography, computerized tomography (CT), percutaneous transhepatic cholangiography (PTHC), and endoscopic retrograde pancreatography with the goal of establishing the site of the biliary tract obstruction. The identification of the site of obstruction could be established by ultrasound 70% to 80%, CT scan 80% to 90%, PTHC 100%, and endoscopic retrograde cholangiography (ERCP) 85%. Therapeutic intervention by radiographic decompression (PTHC or endoscopic prosthesis), surgical bypass, or radiation therapy with or without chemotherapy may be selectively used based on (1) the site of obstruction; (2) the type of primary tumor; and (3) the presence of specific symptoms related to the obstruction. ("Prophylactic" biliary tract decompression to prevent ascending cholangitis is not supported by the literature in that the frequency of sepsis in the face of malignant obstruction is small (in contrast to sepsis associated with stone disease). Furthermore, PTHC with drainage as a long-term procedure is associated with a substantial frequency of sepsis and is unnecessary and possibly problematic as a preoperative procedure simply to reduce the bilirubin level. The use of radiation therapy in conjunction with chemotherapy for patients not deemed suitable for a surgical bypass because of the presence of proximal obstruction is an important alternative to PTHC.

Orthovoltage intraoperative radiotherapy: a new look at an old idea.

A 300 kvp orthovoltage machine has been permanently installed in an operating room for delivering intraoperative radiation therapy (IORT). A historical review of orthovoltage IORT and our present approach are described. The preliminary experience with 38 patients treated with orthovoltage IORT indicates that this technique is feasible, has low acute morbidity, and can be useful for palliation. "Radical" radiation therapy consisting of IORT "boost" treatment combined with external beam was used in 24 patients with primary or recurrent cancer. Local failure in 27 patients treated with IORT +/- external beam radiation therapy was 56%, but varied from 11% (1/9) for patients with resected disease to 78% (14/18) for patients with unresected disease. Complications occurred in nine patients (24%) and have been acceptable. There are 17 patients alive and six are NED, with follow-up of 4-18 months. There appears to be a role for orthovoltage IORT especially when combined with surgical resection for local control of advanced cancer arising in the abdomen where the use of high doses of external radiation therapy are hazardous.

Amino acid clearance and prognosis in surgical patients with cirrhosis.

To measure the effects of cirrhosis on amino acid (AA) flux and to assess the value of the central plasma clearance rate of amino acids (CPCR-AA) as a hepatocyte function test, 35 patients with cirrhosis were studied before and after operation. Fourteen of these patients died after the operation. CPCR-AA measures the number of milliliters of plasma cleared of AA per minute by the liver and other visceral tissues. It is the ratio of AA entry rate into plasma (from peripheral tissues plus infusion) to the arterial AA plasma concentration. Preoperative CPCR-AA measurements in 21 fasted patients with cirrhosis who were not infected revealed a pattern of AA plasma concentration and exchange similar to that previously observed in patients with sepsis with normal liver function. Whereas the concentration of AA in both groups was slightly lower than normal, the CPCR-AA of each was more than four times that of normal postabsorptive people (p less than 0.01). However, preoperative values of CPCR-AA in patients with cirrhosis who survived was 220 +/- 26 ml/M2/min while that in those who died was 97 +/- 16 ml/M2/min (p less than 0.001). Postoperative measurements remained relatively unchanged: survivors 212 +/- 24 ml/M2/min and those who died 89 ml/M2/min (p less than 0.0005). Measurements in vitro of the hepatic protein synthetic rate in liver biopsy specimens taken at operation correlated well with CPCR-AA values obtained immediately before operation in 10 patients (r = 0.73; p less than 0.01). Thus in patients with cirrhosis visceral amino acid uptake and hepatic protein synthesis are maximally stimulated. Nevertheless, if the preoperative CPCR-AA does not approach the value of 284 +/- 76 ml/M2/min previously observed in patients with sepsis who recover, the patient with cirrhosis is prone postoperatively to die of overwhelming infection and multisystem failure.

Intraoperative radiation therapy for biliary tract carcinoma: results of a 5-year experience.

The results of a 5-year experience with use of intraoperative radiation therapy (IORT) in the management of locally advanced bile duct carcinoma are presented. Fifteen patients received IORT doses between 5 and 20 Gy for localized disease, which was either primary and resected with microscopic residual (2 patients), primary and unresected (10 patients), or recurrent (3 patients). Thirteen patients also received postoperative radiation therapy. The median survival of the 12 patients with primary disease was 14 months, with disease controlled in the porta hepatis in 5 of 10 evaluable patients. The three patients with recurrent disease survived 2, 9, and 11 months. There were two operative deaths, for an operative mortality of 13%. Acute and chronic complications are reviewed. Cholangitis is the most frequent in both categories. This aggressive approach in the therapy for advanced disease has an acceptable level of morbidity and may warrant the use of IORT as part of the management of biliary tract cancer.

The Budd-Chiari syndrome and hepatic veno-occlusive disease. Recognition and treatment.

In a review of 29 patients who were surgically treated by combined hepatic and portal decompression for intractable ascites, 18 were identified as falling into the category of the Budd-Chiari syndrome, with varying causes. Of this group, 2 patients were distinguished by the classical hepatic venous endophlebitis described by Chiari and later by Bras et al. Recently, this disease entity has been recognized as being due to the toxic effects of pyrrolizidine alkaloids contained in the Senecio and Crotolaria plants. In the first of these two cases the patient had emigrated from Jamaica and was exposed to "bush trees," but no chemical measurements were done. The second patient had consumed a large amount of comfrey teas, which were shown to contain high levels of pyrrolizidine alkaloids. These two cases add further weight to the existing evidence of the toxic effect of these alkaloids, and also demonstrate the effectiveness of hepatic and portal decompression.

Primary cancer of the liver. Evaluation, treatment, and prognosis.

Between 1970 and 1985, a diagnosis of primary hepatocellular carcinoma was established in 98 patients. Sixty-one cases developed in the presence of chronic liver disease, and only six of these were considered resectable. Of these, the median survival was 19 months. There was one perioperative death. Of the 98 tumors, 37 arose in normal livers. Of the 16 patients with tumors in normal livers that were resected, all survived operation. The long-term median survival was 32 months. Two subsets of the fibrolamellar and clear-cell variants appeared to carry a more favorable prognosis.

Surgical therapy for recurrent liver metastases from colorectal cancer.

Forty percent of patients whose disease recurs after hepatic resection for liver metastases from colorectal cancer initially will have liver-only metastases. We have retrospectively reviewed our experience with repeated surgical treatment for liver-only recurrence after previous hepatic resection for colorectal metastases. Repeated hepatic procedures were performed with no mortality in 10 patients. Intraoperative ultrasound allowed identification of three unsuspected metastases and determination of unresectability of two metastases during 11 procedures. Three patients were free of disease at 31, 41, and 48 months from the first hepatic procedure and at 15, 31, and 43 months from the second procedure. Five patients have remained free of hepatic disease. Patients whose initial metastases were less than 6 cm in diameter and had single liver recurrences after hepatic resection appeared to be the best candidates for further surgical therapy. These data and a review of the literature suggest that surgical treatment of recurrent liver metastases from colorectal cancer can be performed safely, and it is associated with long-term disease-free survival in up to 38% of highly selected patients.

Management of recurrent pelvic tumors.

The management of regional tumor recurrence in the pelvis traditionally has been a difficult problem for surgeons and oncologists. The only meaningful therapy for these patients is a potentially curative re-resection. The records and operative reports of 29 patients with regional pelvic tumor recurrence treated between 1981 and 1986 were reviewed. The operative procedures performed included three bowel resections, six abdominoperineal resections, eight pelvic exenterations, eight resections of tumor recurrence, and four conservative procedures. There was one operative death in this group. Significant morbidity was noted in the group but was clustered in a small number of patients operated on early in the series. The median follow-up in this series was 13 months (range, two to 51 months). Nineteen (65%) of the patients are surviving at a median follow-up of ten months (range, two to 51 months). The median survival (following resection) in the ten patients (35%) who died was 18 months. In 15 (52%) of the patients, a complete resection was performed. In this group, the survival is 80% with a median follow-up of 11 months. Seven (37%) are surviving with no evidence of disease. Palliation of symptoms occurred in 23 (79%) of the 29 patients. Radical resection of tumor recurrence in the pelvis can be performed with acceptable mortality and complication rates. This therapy should be considered for further clinical trials combining surgical and adjuvant therapy in patients with regional pelvic tumor recurrence.

Surgical treatment of biliary cystadenoma. A report of 15 cases.

Mucinous biliary cystadenomas are rare intrahepatic or, less commonly, extrahepatic neoplasms that may produce massive enlargement, hemorrhage, rupture, secondary infection, jaundice, or vena caval obstruction. Radiologic criteria differentiate biliary cystadenomas from more common parasitic or simple cysts. Treatment has included sclerosis, marsupialization, internal drainage, or resection, but without resection the patient is at risk for enlargement, infection, or progression of an unrecognized malignant neoplasm. We report the course of 15 patients who underwent resection for biliary cystadenoma to elucidate the clinical presentation, preoperative evaluation, and surgical treatment. Nine patients had had previous radiologic or surgical intervention other than excision, and complications of sepsis and tumor recurrence had developed. Following complete resection, however, only five postoperative complications were encountered, and no patient experienced recurrence of tumor. Thus, we recommend complete surgical resection as the preferred therapy.

Amino acid clearance in cirrhosis. A predictor of postoperative morbidity and mortality.

The central plasma clearance rate of amino acids (CPCR-AA), the ratio of peripheral amino acid entry rate into blood plasma to arterial amino acid concentration, was measured preoperatively in 149 noninfected cirrhotic patients. In 50 survivors of shunting or general surgical procedures, the mean (+/- SEM) CPCR-AA was 201 +/- 17 mL/m2/min; in 39 subsequent deaths, the mean ratio was 87 +/- 14 mL/m2/min. Comparing Child's classification with CPCR-AA reveals the following values: class A (mortality, two of ten patients) survivors, 152 +/- 23 mL/m2/min; class A deaths, 96 +/- 54 mL/m2/min; class C (mortality, 13 of 19 patients) survivors, 214 +/- 47 mL/m2/min; class C deaths, 101 +/- 13 mL/m2/min. The preoperative CPCR-AA of 46 patients receiving liver transplants was 91 +/- 9 mL/m2/min; 69% of these patients survived. Preoperative CPCR-AA values correlated significantly with rates of hepatic protein synthesis in incubated liver slices obtained by biopsy at operation in 22 patients. Thus, CPCR-AA determination is a true liver function test, valuable in predicting surgical mortality and selecting transplantation or other operations for cirrhotic patients.

Technical and biological factors in disease-free survival after hepatic resection for colorectal cancer metastases.

Careful patient selection for hepatic resection of colorectal cancer metastases is essential to improve current poor results. Carcinoembryonic antigen level and number of metastases were significant preoperative prognostic indicators of 5-year disease-free survival in patients selected clinically for hepatic surgery. Surgical margin, weight of hepatic tissue resected, carcinoembryonic antigen level, and flow cytometry were significant postoperative prognostic indicators. Patients with a carcinoembryonic antigen level less than 200 ng/mL, 1-cm surgical margins, and less than 1,000 g of liver tissue removed had a greater than 50% estimated 5-year disease-free survival rate. If the metastases were diploid on flow cytometry, an additional survival advantage may have been gained. Inadequate surgical margins led to high rates of liver-only recurrence. Nonhepatic recurrence was unrelated to surgical margins. Intraoperative liver examination by ultrasound during primary colon cancer resection and adjuvant chemotherapy may offer earlier selection of biologically appropriate patients and improved outcome; both recommendations require clinical trials.

Portoazygous disconnection for bleeding esophageal varices.

Between 1971 and 1982, 20 portoazygous disconnections (modified Tanner's operation) were performed in patients with bleeding esophagogastric varices who were anatomically portosystemic shunting. Immediate control of variceal hemorrhage was achieved in all patients, although rebleeding occurred after eight operations at intervals from 2 days to 7.5 years postoperatively, requiring additional surgery at a mean interval of 2.5 years. There were eight perioperative deaths. Analysis has suggested increased mortality in patients with more severely impaired liver function according to Child's classification, and in patients who require urgent or emergent operations. There was an 80 percent incidence of major and minor complications. Portoazygous disconnection is not a satisfactory alternative to portosystemic shunting, except in a selected group of patients with intact hepatic function and with anatomic characteristics that preclude usual shunting procedures.

Pancreas divisum. Results of surgical intervention.

The embryologic defect that results when the ventral and dorsal anlages of the pancreas do not fuse has been referred to as pancreas divisum. ERCP has made it possible to recognize this anomaly in patients undergoing investigation for otherwise unexplained abdominal pain. Of 70 patients in whom recurrent epigastric pain and pancreas divisum coexisted, sphincteroplasty of both papillae was carried out in 19 because of intractability of symptoms. In six patients, surgery was performed subsequent to failure of other biliary tract surgery. There was one postoperative death. In the remaining 18 patients, initial results were good to excellent in 13 and fair in 1. In four patients, however, recurrence of symptoms developed within periods that ranged from 1 to 6 months; therefore, reasonably permanent relief was limited to 10 patients. Of the remaining eight patients with recurrent or continuing symptoms, a variety of subsequent procedures led to satisfactory results in only three. In only seven patients was there even minimal chemical or microscopic evidence to suggest active pancreatitis. Similarly, pancreatograms in 17 patients with this anomaly revealed no abnormalities except for minor ones in 2 patients. Thus, if this is a syndrome that is due to relative stenosis of the lesser papilla and duct, the anomaly does not often result in documented pancreatitis. The definite but limited success rate from sphincteroplasty suggests that relative stenosis of the lesser papilla may be the cause of a syndrome but surgical refinements will be necessary to achieve a better operative success rate.

Noncirrhotic portal hypertension in adults.

Of 366 cases of portal hypertension in adult patients referred for evaluation and management in the past 15 years, the cause was not related to cirrhosis or hemochromatosis in 41. No specific cause was demonstrated for portal hypertension in four cases, which were excluded from further evaluation. Of the remaining 37 patients, 26 had a presinusoidal block characterized primarily by bleeding from esophagogastric varices, and 9 had a postsinusoidal block characterized by the rapid development of intractable ascites. In two cases an arteriovenous fistula was the cause of portal hypertension. Treatment was operative or nonoperative depending on the nature and prognosis of the basic disease. The various approaches to therapy include shunting procedures for the control of ascites or esophagogastric varices, the use of a type of portal-azygous disconnection and a direct approach to a valve or a fistula. In the absence of a rapidly fatal primary disease, portal hypertension is not a threatening problem and may be controlled with minimal mortality by appropriate surgical management.

Budd-Chiari syndrome. Historical and clinical review with an analysis of surgical corrective procedures.

Seventeen patients who fulfilled the criteria for the Budd-Chiari syndrome (centrilobular congestion and necrosis, a defined postsinusoidal block, and rapid onset of ascites) have been analyzed in terms of cause, prognosis, and treatment. Causal factors included caval web or tumor, hepatic tumor, a hypocoagulable state, myeloproliferative disease, and veno-occlusive disease. Location of the outflow block was suprahepatic (vena cava or major hepatic veins) in 13 patients and intrahepatic in 4. In five patients, a side-to-side portacaval shunt was effective in dissipating ascites with restoration to a normal lifestyle, as were transatrial fracture of a caval web (one patient) and resection of a huge cystadenoma of the liver (one patient). A peritoneal shunt provided effective palliation in three patients.

Postgastrectomy syndromes.

Postgastrectomy syndromes requiring further operation are fortunately uncommon, as the symptoms are disabling and the results of corrective surgery are, at times, disappointing. Our sixty-six patients underwent a total of seventy-six procedures with forty-one successful results and thirty-five failures. Among the secessful group, only fourteen results were graded as excellent. (Table V.) Our experience, like that of others, demonstrates the necessity of accurate evaluation of the patient and of accurate syndrome classification. This not only allows the appropriate operation to be chosen but also helps to indicate those in whom operation should be avoided. Where more than one surgically remediable syndrome exists, simultaneous correction should be undertaken. Treatment of the mechanical problems of obstructed afferent loop by jejunojejunostomy and of stomal obstruction by complete stomal reconstruction provides satisfactory results. Roux-en-Y anastomosis is effective in patients with alkaline gastritis, but we caution against the use of this procedure in patients with vague symptoms and minimal endoscopic changes. Antiperistaltic jejunal reversal is the procedure of choice in managing severe postvagotomy diarrhea. Although most patients with dumping can be managed conservatively, a small number with severe symptoms and nutritional problems cannot and require further operation. Our experience with conversion from Billroth II to Billroth I and with isoperistaltic interposition, although minimal, has been reasonably satisfactory. Four groups of patients remain with symptoms of chronic vomiting, late postvagotomy atonic stomach, dumping "plus," and miscellaneous symptoms. These patients have complaints that are difficult to define and usually have poor results with further operations. We believe that surgery should be avoided in these patients and that conservative measures be continued.

Experience with colorectal carcinoma metastatic to the liver.

The predilection of colorectal cancer metastases for the liver is probably the result of several factors, including the blood supply, the "homing" characteristics of the tumor cells, and the state of the liver. Five-year survival rates after hepatic resection for colorectal cancer metastases range from 20 to 40 per cent, and some other patients obtain palliative benefit. The authors discuss the three presentations of liver metastases, operative techniques, and prognostic factors.