Todd M. McCarty

Optimizing Outcomes in Bariatric Surgery: Outpatient Laparoscopic Gastric Bypass

Background:Roux-en-Y gastric bypass (RYGB) is an effective treatment of severe obesity and one of the fastest growing surgical procedures in the United States. Methods:A single institution prospective database of patients undergoing outpatient laparoscopic (lap) RYGB over a 3-year period was reviewed. Study end points included hospital discharge within 23 hours, 30-day hospital readmission rate, early (<30 day) and late complication rates, and 30-day perioperative mortality. Variables assessed included surgeon experience, patient demographics, comorbidities, operative time, Roux limb pathway, intraoperative steroid bolus, and use of dexmedetomidine. Results:Two thousand consecutive patients undergoing outpatient lap RYGB were identified, and 84% (n = 1669) were discharged within 23 hours. Of these, 1.7% (n = 34) were readmitted within 30 days. The overall early and late complication rates were 1.9% (n = 38) and 4.3% (n = 86), respectively. The 30-day mortality rate was 0.1% (n = 2), and neither patient was discharged before death. Univariate analysis demonstrated surgeon experience (<50 cases), age (<56 years), body mass index (<60 kg/m2), weight (400 lbs), comorbidities (<5), and intraoperative steroid bolus as predictive of successful outpatient discharge. Multivariate analysis revealed surgeon experience, comorbidities, body mass index, and steroid bolus as predictive variables. Conclusions:These data suggest that outpatient lap RYGB can be performed with acceptable perioperative complication rates, hospital readmission, and mortality rates. Surgeon experience, careful patient selection, and the use of intraoperative steroid bolus predicted optimal patient outcomes.

A prospective phase II trial of ONYX-015 adenovirus and chemotherapy in recurrent squamous cell carcinoma of the head and neck (the Baylor experience).

AbstractBackground: The E1-b attenuated adenovirus, ONYX-015 (Onyx Pharmaceuticals, Richmond, CA), has demonstrated antitumoral activity in patients with recurrent squamous cell carcinoma of the head and neck. This study evaluated the effects of intratumoral ONYX-015 injection combined with systemic chemotherapy. Methods: Inclusion criteria included: (1) recurrent squamous cell carcinoma of the head and neck, not surgically salvageable, (2) target tumor amenable to direct injection, and (3) no prior chemotherapy for recurrent disease. Patients received ONYX-015 (1010 plaque-forming units) intratumorally for 5 days, cisplatin (80 mg/m2) on day 1, and 5-fluorouracil (800–1000 mg/m2) on days 1–5. This cycle was repeated every 3 weeks. Serial physical examination and computed tomography were used to assess tumor size and treatment response. Results: Fourteen patients were enrolled, and nine patients were evaluable for response at the time of enrollment. The mean age of the evaluable patients was 60.8 years (range, 46–71 years). Mean maximum tumor diameter was 4.8 cm (range, 1.9–10.5 cm). Treatment-related toxicity included nausea (n=7, 77.8%), vomiting (n=5, 55.6%), mucositis (n=5, 55.6%), pain at the injection site (n=5, 55.6%), constipation (n=4, 44.4%), and fatigue (n=4, 44.4%). Locoregional tumor control was obtained in all nine patients (100%) (mean observation time, 157 days). Complete clinical response was seen in three patients (33.3%), partial response was seen in three patients (33.3%), minor response was seen in one patient (11.1%), and two patients (22.2%) had stable disease. Median time to local progression of disease has not been reached (range, 35–356 days). Conclusions: ONYX-015 adenovirus plus systemic cisplatin and 5-fluorouracil provides antitumor activity and local tumor control in patients with recurrent squamous cell carcinoma of the head and neck. This novel treatment approach offers hope for patients with limited treatment alternatives and provides the foundation for a phase III clinical trial.

Radiation safety with breast sentinel node biopsy

BACKGROUND Sentinel lymph node biopsy with Technetium 99m sulfur colloid (Tc99m) is an evolving technique that offers the potential for improved staging of breast cancer with decreased morbidity. However, the use of radioactive materials in the operating room generates significant concern about radiation exposure. The purpose of this study was to evaluate radiation exposure to operating room personnel, pathologist, and equipment from specimens during breast sentinel lymph node biopsy. METHODS Twenty patients were injected with 0.7 to 1.1 mCi of Tc99m sulfur colloid 1.5 to 3 hours before sentinel lymph node biopsy. A calibrated Geiger counter was used to measure dose rates from the breast injection site before skin incision (n = 20), lumpectomy specimens (n = 8), and sentinel nodes (n = 20) at distances of 3, 30, and 300 cm. This represented exposure to the surgeons hands, surgeons torso, and scrub nurse, respectively. Exposure to the pathologists hands and torso was represented as dose-rate measurements from lumpectomy and nodal specimens. The operative instruments, trash receptacles, suction canisters, pathology slides, and cryostat machines were measured at 3 cm at the conclusion of each procedure. Specimens or equipment emitting radiation doses equal to background levels (0.04 mRem/h) were exempt from special handling and disposal. RESULTS The highest exposure rate was to the surgeons hands from the breast injection site before skin incision (34.25 mRem/h). Exposure to the surgeons torso measured 1.33 mRem/h, and exposure to the scrub nurses torso measured 0.15 mRem/h from the injection site. Exposure to the pathologists hands was 18.62 and 0.06 mRem/h from the lumpectomy specimen and sentinel node, respectively. Exposure to the pathologists torso measured 0.34 and 0.04 mRem/h from the lumpectomy specimen and sentinel node, respectively. One hundred percent of lumpectomy specimens measured above the exempt level. Thirty-two of 46 (70%) sentinel lymph nodes emitted radiation equal to the exempt background level. Seventeen of 20 trash receptacles (85%) and 4 of 12 (33%) suction canisters measured equal to background levels. All operative instruments, pathology slides, and cryostat machines were equal to background levels. CONCLUSIONS Radiation exposure to operating room personnel, pathologists, and operative equipment during a breast sentinel node biopsy using Tc99m is minimal. A primary surgeon can perform 2,190 hours, a scrub nurse 33,333 hours, and a pathologist 14,705 hours of procedural work before surpassing Occupational Safety and Health Administration limits. Operative instruments, pathology slides, and cryostat machines do not require special handling. All lumpectomy specimens should be stored for decontamination until the dose rate equals background levels. Intraoperative dose-rate monitoring allows selective decontamination of nodal specimens, trash receptacles, and suction canisters, which decreases disposal time and cost.

The role of computed tomography in the diagnosis of acute appendicitis.

BACKGROUND Routine contrast-enhanced computed tomography (CECT) has been described as an accurate diagnostic imaging modality in patients with acute appendicitis. However, most patients with acute appendicitis can be diagnosed by clinical findings and physical exam alone. The role of CECT in patients suspected of having appendicitis but with equivocal clinical exams remains ill defined. METHODS One hundred and seven consecutive patients who were thought to have appendicitis but with equivocal clinical findings and/or physical exams were imaged by CECT over a 12-month period. Oral and intravenous contrast-enhanced, spiral abdominal and pelvic images were obtained using 7-mm cuts. CECT images were interpreted by a board-certified radiologist. Main outcome measures included CECT sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy in the diagnosis of acute appendicitis, comparing CECT with ultrasound, and determining the impact of CECT on the clinical management of this patient population. RESULTS A group of 107 patients consisting of 44 males (41%) and 63 females (59%) with a median age of 33 years (range 13 to 89 years) were imaged with CECT to evaluate suspected appendicitis. Of the 107 CECTs performed, 11 false-positive and 3 false-negative readings were identified, resulting in a sensitivity of 92%, specificity of 85%, PPV of 75%, NPV of 95%, and an overall accuracy of 90%. Forty-three patients were imaged with ultrasound and CECT, and CECT had significantly better sensitivity and accuracy (30% versus 92% and 69% versus 88%, P<0.01). With regard to clinical management, 100% (36/36) of patients with appendicitis, and 4.2% (3/71) of patients without appendicitis underwent appendectomy. Therefore, the overall negative appendectomy rate was 7.6% (3/39). CONCLUSIONS CECT is a useful diagnostic imaging modality for patients suspected of having acute appendicitis but with equivocal clinical findings and/or physical exams. CECT is more sensitive and accurate than ultrasound and is particularly useful in excluding the diagnosis of appendicitis in those without disease.

Cryosurgical ablation of hepatic tumors

BACKGROUND Cryosurgical ablation of hepatic tumors relies on nonspecific tissue necrosis due to freezing as well as microvascular thrombosis. Patients with selected primary and metastatic hepatic malignancies who are not candidates for surgical resection are afforded potentially curative benefit using this technique. METHODS Forty patients underwent cryosurgery for hepatic malignancy related to colorectal metastasis (n = 27), hepatocellular carcinoma (n = 8), metastatic breast (n = 2), metastatic neuroendocrine (n = 2), and metastatic ovarian carcinoma (n = 1). Intraoperative ultrasound (IOUS) was used in all patients to help locate the tumor and guide the cryosurgical trocar to the lesions. RESULTS Indications for cryosurgical ablation included bilobar and centrally located disease, poor medical risk, insufficient hepatic reserve, and involved margin after wedge resection. Major complications included hepatic parenchyma cracking requiring transfusion in 5 patients, 1 postoperative biliary stenosis, and 1 inferior vena cava injury. There were 3 postoperative deaths from non-hepatic-related events. Based on Kaplan-Meier analysis the estimated overall survival for patients with hepatocellular carcinoma (60% at 18 months) was compared with patients with colorectal metastases (30% at 18 months). Nine patients (23%) are currently free of disease with an average follow-up of 17.7 months. The pattern of failure was identified at the site of cryosurgical ablation in 2 of 88 lesions. CONCLUSIONS Cryosurgical ablation of selected hepatic malignancies is a safe and viable treatment for patients not amenable to surgical resection.

Establishing a laparoscopic gastric bypass program

OBJECTIVE To evaluate the outcomes for laparoscopic Roux-en-Y gastric bypass in a newly developed bariatric surgery program. METHODS A prospective analysis of the initial 100 patients who underwent laparoscopic Roux-en-Y gastric bypass at a community based teaching hospital between December 2000 and October 2001 was performed. Study endpoints included operative time, early (less than 7 days) and late complication rates, hospital length of stay (LOS), time to initiation of oral diet, and percentage of excess body weight loss. RESULTS There were 91 women and 9 men with a mean age of 39 years (range 21 to 57). Mean preoperative weight was 126.4 kg (range 92.3 kg to 214 kg), with a mean preoperative body mass index of 47.4 (range 37.3 to 75.7). Ninety (90%) patients had at least one significant medical comorbidity (median = 6 per patient). Mean operative time was 2.4 hours (range 1.0 to 6.5; 3.0 hours for the first 50 patients and 1.8 hours for the last 50 patients). Three patients required conversion to open gastric bypass, all due to equipment failure (two harmonic scalpel failures and one linear stapler malfunction). Seven patients had early complications, 3 with anastomotic hemorrhage requiring transfusion, 3 with intestinal leaks requiring reoperation, and 1 with transected nasogastric tube. Eleven patients had late complications: 5 patients with small bowel obstruction, all due to herniation through the transverse colon mesentery (these occurred early in the series, prompting a change in technique, with no subsequent occurrences), 3 with gastrojejunostomy strictures requiring endoscopic dilation, 2 superficial wound infections, and 1 port-site incisional hernia. No complications occurred in the last 40 patients. No deaths occurred. Median hospital stay was 2 days (range 1 to 37); 3 days in the first 50 cases and 1 day in the last 50 cases. The median number of days to the start of an oral diet was 1 day. Average excess body weight loss was 34% (median follow-up 4 months). CONCLUSIONS Laparoscopic Roux-en-Y gastric bypass is a technically challenging procedure that can be safely integrated into a bariatric treatment program with good results. Improved outcomes, shorter operative times, and fewer complications are associated with increased surgical experience.

TNFerade, an Adenovector Carrying the Transgene for Human Tumor Necrosis Factor α, for Patients With Advanced Solid Tumors: Surgical Experience and Long-Term Follow-Up

BackgroundOver the last several years, attempts have been made to use the tumoricidal effects of tumor necrosis factor (TNF)-α to treat cancer. Many of these studies demonstrated dose-limiting systemic side effects from high concentrations of TNF-α. The recent focus has been on developing a local delivery system for TNF-α to minimize the systemic response.MethodsThis study was part of a phase I open-label multi-institutional trial using TNFerade. We focus on the patients treated at Baylor University Medical Center and provide postoperative and long-term follow-up. TNFerade uses a second-generation nonreplicating adenovirus as the vector for delivery of the human transgene TNF-α. An early growth response 1 promoter was placed upstream from the TNF-α gene. This promoter is activated by ionizing radiation, thus allowing for temporal and spatial control of TNF-α release. Tumors were injected over 5 weeks with ionizing radiation given 3 days after injections for 6 weeks. Tumor response was measured by computed tomographic imaging and physical examination.ResultsAs described in our original experience, no patients experienced dose-limiting toxicities up to doses of 4 × 1011 particles per injection. Tumors injected demonstrated a response independently of histology. Four patients had complete regression of the tumor injected. Three patients with complete regression have survived ≥2 years from the time of treatment.ConclusionsBoth short-term and long-term safety are observed with TNFerade. These data demonstrate the need for phase II trials.

Should locally excised T1 rectal cancer receive adjuvant chemoradiation

BACKGROUND Local excision of low-lying adenocarcinoma of the rectum is increasingly utilized, but the benefit of adjuvant treatment in T1 lesions with otherwise favorable pathology remains controversial. METHODS A retrospective review was performed on patients who underwent local excision of invasive rectal cancer with curative intent from 1991 to 1999. RESULTS Forty-eight patients were treated with local surgical excision. Twenty-seven T1 lesions were identified, 10 received postoperative chemoradiation, and no local recurrences were identified. Seventeen T1 patients did not receive adjuvant treatment and local recurrence occurred in 4 patients (24%). In all cases of local recurrence, the lesions had been excised to negative margins, none were poorly differentiated, and none exhibited vascular or lymphatic invasion. CONCLUSION These data suggest a trend toward improved local control with adjuvant therapy after local excision of T1 rectal cancer. This is an important consideration in patients with negative surgical margins and favorable pathology who are traditionally not treated.

Comparison of quick parathyroid assay for uniglandular and multiglandular parathyroid disease

BACKGROUND The quick intraoperative parathyroid assay (qPTH) has been proposed as an effective tool in the surgical management of hyperparathyroidism. This assay may facilitate directed, unilateral exploration for uniglandular disease; however, its role in the management of multiglandular disease remains unclear. The purpose of this study is to evaluate the use of qPTH in parathyroid surgery, and to compare the results for uniglandular and multiglandular disease. METHODS A prospective analysis of 63 consecutive patients explored for hyperparathyroidism using the qPTH assay was performed. Preoperative localization studies including ultrasonography and sestamibi scan were routinely obtained. Blood samples for qPTH were routinely drawn prior to the surgical incision, prior to gland excision, as well as 5 and 10 minutes after gland excision. Patients with primary or secondary hyperplasia had blood samples drawn relative to a 3-1/2 gland resection. Additional samples were drawn as needed for patients with a double adenoma. A qPTH decline of greater than or equal to 50% of the highest preincision or gland preexcision level was considered successful. Unilateral neck exploration was routinely performed unless multiglandular disease was identified. Patients were followed up postoperatively with serum calcium levels and an 8-month median follow-up was recorded. RESULTS Forty-nine of 63 (78%) patients were found to have a solitary parathyroid adenoma. The qPTH assay was successful in 48 (97%) patients with uniglandular disease. Forty-four of these 48 patients showed an appropriate assay decline 5 minutes after adenoma excision. One patient with a single adenoma showed a delayed 50% decline in qPTH at 20 minutes. Fourteen (22%) patients were found to have multiglandular disease: 6 patients with primary hyperplasia, 4 patients with hyperplasia secondary to renal failure, and 4 patients with double adenomas. All patients with multiglandular disease demonstrated a successful decrease in qPTH levels. All patients with hyperplasia secondary to renal failure showed a successful assay decline 5 minutes after 3-1/2 gland resection. Eight of 14 (57%) patients with multiglandular disease (4 double adenomas, and 4 hyperplasia) were suspected to have solitary adenomas preoperatively. Overall, 62 of 63 (98%) patients showed an appropriate assay decline within 10 minutes after gland excision. Postoperatively, all patients were normocalcemic with a median follow-up of 8 months. CONCLUSIONS These data suggest that qPTH can accurately facilitate unilateral, directed neck exploration for uniglandular parathyroid disease, as well as guide the extent of gland resection for multiglandular disease. This assay reliably eliminates the most common cause of parathyroidectomy failure, which is unrecognized multiglandular disease. The qPTH assay can reliably be used with similar accuracy for patients with multiglandular disease as has been shown for uniglandular parathyroid disease.

Hepatic Tumor Imaging Using Iron Oxide MRI: Comparison With Computed Tomography, Clinical Impact, and Cost Analysis

Background: The surgical management of hepatic tumors has traditionally relied on preoperative contrast-enhanced computed tomography (CECT) in combination with intraoperative ultrasonography (IOUS). Unfortunately, the ability to detect and characterize hepatic tumors by using CECT is limited, and IOUS frequently reveals additional disease that alters the operative approach. Recent advances in hepatic magnetic resonance imaging (MRI) may improve preoperative tumor detection and characterization; however, little is known about how MRI compares with CECT or about the clinical impact and cost considerations of liver MRI.Methods: A retrospective chart review was performed to compare iron oxide (Feridex [Fe])-MRI with CECT in the preoperative imaging of hepatic neoplasms, as well as to determine the clinical impact and overall healthcare costs associated with Fe-MRI.Results: Of approximately 1000 patients who underwent abdominal MRI at a single institution during a 20-month period, 57 were identified who underwent Fe-MRI evaluation of the liver. Indications for imaging included suspected metastases (n = 43), an indeterminate hepatic mass (n = 9), or primary hepatic cancer (n = 5). Overall, Fe-MRI identified a total of 157 lesions (mean, 2.75 per patient; range, 0–14). CECT was performed in 50 patients, of whom 35 had primary or metastatic cancer. Fe-MRI identified more lesions than CT (n = 136 vs. 77; P = .016), and the average size of lesion detected by Fe-MRI was significantly smaller than that by CECT (2.5 vs. 3.4 cm; P = .018). Comparison of CECT and Fe-MRI findings with IOUS and pathological specimens showed a significant difference in sensitivity (MRI, 86%; CECT, 58%; P, .001), and IOUS changed the operative approach in only 5% of those imaged with Fe-MRI. Overall, Fe-MRI altered the clinical management in 67% of patients imaged (n = 38 of 57), which corresponded to an overall net cost savings of