Two randomized, double-blind, placebo-controlled, dose-escalation phase 1 studies evaluating BTH1677, a 1, 3-1,6 beta glucan pathogen associated molecular pattern, in healthy volunteer subjects.

BACKGROUND: BTH1677 is a beta glucan pathogen associated molecular pattern (PAMP) currently being investigated as a novel cancer therapy. Here, the initial safety and pharmacokinetic (PK) results of BTH1677 in healthy subjects are reported. SUBJECTS AND METHODS: In the Phase 1a single-dosing study, subjects were randomized (3:1 per cohort) to a single intravenous (i.v.) infusion of BTH1677 at 0.5, 1, 2, 4, or 6 mg/kg or placebo, respectively. In the Phase 1b multi-dosing study, subjects were randomized (3:1 per cohort) to 7 daily i.v. infusions of BTH1677 at 1, 2, or 4 mg/kg or placebo, respectively. Safety and PK non-compartmental analyses were performed. RESULTS: Thirty-six subjects (N = 24 Phase 1a; N = 12 Phase 1b) were randomized to treatment. No deaths or serious adverse events occurred in either study. Mild or moderate adverse events (AEs) occurred in 67% of BTH1677-treated subjects in both studies. Treatment-related AEs (occurring in ≥10% of subjects) included dyspnea, flushing, headache, nausea, paraesthesia, and rash in Phase 1a and conjunctivitis and headache in Phase 1b. BTH1677 serum concentration was linear with dose. Clearance, serum elimination half-life (t1/2) and volume of distribution (Vss) were BTH1677 dose-independent. In Phase 1b, area under the curve, t1/2, and Vss values were larger at steady state on days 6-30 versus day 0. CONCLUSIONS: BTH1677 was well tolerated after single doses up to 6 mg/kg and after 7 daily doses up to 4 mg/kg.

Dexamethasone, light anaesthesia, and tight glucose control (DeLiT) randomized controlled trial.

BACKGROUND: The inflammatory response to surgical tissue injury is associated with perioperative morbidity and mortality. We tested the primary hypotheses that major perioperative morbidity is reduced by three potential anti-inflammatory interventions: (i) low-dose dexamethasone, (ii) intensive intraoperative glucose control, and (iii) lighter anaesthesia. METHODS: We enrolled patients having major non-cardiac surgery who were ≥40 yr old and had an ASA physical status ≤IV. In a three-way factorial design, patients were randomized to perioperative i.v. dexamethasone (a total of 14 mg tapered over 3 days) vs placebo, intensive vs conventional glucose control 80-110 vs 180-200 mg dl(-1), and lighter vs deeper anaesthesia (bispectral index target of 55 vs 35). The primary outcome was a collapsed composite of 15 major complications and 30 day mortality. Plasma high-sensitivity (hs) C-reactive protein (CRP) concentration was measured before operation and on the first and second postoperative days. RESULTS: The overall incidence of the primary outcome was about 20%. The trial was stopped after the second interim analysis with 381 patients, at which all three interventions crossed the futility boundary for the primary outcome. No three-way (P=0.70) or two-way (all P>0.52) interactions among the interventions were found. There was a significantly smaller increase in hsCRP in patients given dexamethasone than placebo [maximum 108 (64) vs 155 (69) mg litre(-1), P<0.001], but none of the other two interventions differentially influenced the hsCRP response to surgery. CONCLUSIONS: Among our three interventions, dexamethasone alone reduced inflammation. However, no intervention reduced the risk of major morbidity or 1 yr mortality. TRIAL REGISTRATION IDENTIFIER: NCT00433251 at www.clinicaltrials.gov.

Improved quality of life following total pancreatectomy and auto-islet transplantation for chronic pancreatitis.

BACKGROUND: Total pancreatectomy (TP) with auto-islet transplant (AIT) is an extreme treatment for chronic pancreatitis, and we reviewed our experience to assess the impact on quality of life (QOL). METHODS: A prospective cohort study from 2007 through 2010 with pre- and postoperative assessments of the Depression Anxiety Stress Scale, Pain Disability Index, and visual analogue pain scale was performed. RESULTS: Twenty patients underwent TP-AIT with a median follow-up of 12 months (6.75-24 months). All patients reported moderate (45 %) to severe (55 %) pain prior to surgery. TP-AIT resulted in significant decreases in abdominal pain (p < 0.001), 80 % reporting no or mild pain. Despite pain improvement, only 30 % discontinued narcotics. Improvements in all PDI QOL domains improved from 79 to 90 % (p = 0.002), with greatest improvements seen in those without prior pancreatic surgery, younger patients, and in those with higher levels of preoperative pain. Patients were less affected by depression and anxiety prior to surgery, but 60 and 70 % did show improvement in depression and anxiety, respectively (p = 0.033). Sixteen patients (80 %) required exogenous insulin at last follow-up (mean total dose of insulin 11.6 U/day). CONCLUSIONS: TP-AIT significantly improves pain and QOL measures in appropriately selected patients with CP.

Laparoscopic robotic-assisted pancreaticoduodenectomy: a case-matched comparison with open resection.

BACKGROUND: Minimally invasive procedures have expanded recently to include pancreaticoduodenectomy (PD), but the efficacy of a laparoscopic robotic-assisted approach has not been demonstrated. A case-matched comparison was undertaken to study outcomes between laparoscopic robotic approach (LRPD) and the conventional open counterpart (OPD). METHODS: From March 2009 through December 2010, 30 LRPD were performed by two pancreaticobiliary surgeons at the Cleveland Clinic. Thirty OPD patients operated by four pancreaticobiliary surgeons during this same period were matched by demographics, and postoperative outcomes were compared from review of a prospectively collected database. RESULTS: Mean age was 62 years for LRPD versus 61 years for OPD (p = 0.43). Mean body mass index was 24.8 versus 25.6 kg/m(2) (p = 0.49). Surgical indications included adenocarcinoma in 14 patients from each group (46%), intraductal papillary mucinous neoplasm in 4 (14%), and other in 12 (40%). There was one preoperative death in the LRPD group and none following OPD. Morbidity occurred in nine patients (30%) following LRPD versus 13 (44%) in the OPD group (p = 0.14). Intraoperative factors assessed included blood loss (485.8 vs 775 ml, p = 0.13) and operative time (476.2 vs 366.4 min, p = 0.0005). Conversion from LRPD to open occurred in three patients (12%) due to bleeding. Reoperation was performed in two patients (6%) following LRPD versus seven (24%) following OPD (p = 0.17). Length of hospital stay was 9.79 days for LRPD versus 13.26 days in the OPD group (p = 0.043). CONCLUSIONS: This is the first comparison of a novel laparoscopic robotic-assisted PD with the open PD in a case-matched fashion. Our data demonstrate a significant increase in operative time but decreased length of stay for LRPD. The favorable morbidity following LRPD makes it a reasonable surgical approach for selected patients requiring PD.

The quality of information on three common ENT procedures on the Internet.

BACKGROUND: The Internet hosts a large number of high-quality medical resources and poses seemingly endless opportunities to inform, teach, and connect professionals and patients alike. However, it is difficult for the lay person to distinguish accurate from inaccurate information. AIM: This study was undertaken in an attempt to assess the quality of information on otolaryngology available on the Internet. METHODS: Sixty appropriate websites, using search engines Yahoo and Google, were evaluated for completeness and accuracy using three commonly performed ENT operations: tonsillectomy (T), septoplasty (S), and myringoplasty (M). RESULTS: A total of 60 websites were evaluated (NT = 20, NM = 20, NS = 20). A total of 86.7% targeted lay population and 13.3% targeted the medical professionals. 35% of the sites included all critical information that patients should know prior to undergoing surgery and over 94% of these were found to contain no inaccuracies. Negative bias towards medical profession was detected in 3% of websites. CONCLUSIONS: In the current climate, with informed consent being of profound importance, the Internet represents a useful tool for both patients and surgeons.

Comparison of laparoscopic versus open liver tumor resection: a case-controlled study.

BACKGROUND: Although there are data in the literature about the safety and efficacy of laparoscopic liver resections, there are not many studies comparing laparoscopic versus open approaches in a case-matched design. The purpose of this study is to compare the perioperative outcome of laparoscopic versus open liver resections from a single institution. METHODS: Thirty-one patients underwent laparoscopic liver resection between April 1997 and August 2007, with a prospective laparoscopic program started in April 2006 (n=25). This group of patients was compared with 43 consecutive patients undergoing open resection who were matched by size of the lesion (5 cm or less for malignant and 8 cm or less for benign), anatomical location (segments 2, 3, 4b, 5, 6), and type of resection (wedge resection, segmentectomy, partial liver resection). Data were obtained from medical records as well as from a prospective database. Statistical analysis was performed using t-test and chi-square. All data are expressed as mean +/- standard error on the mean (SEM). RESULTS: Mean age in the laparoscopic group was 57.6+/-2.7 years versus 61.9+/-2.3 years in the open group (p=0.2). There were more women in the laparoscopic group [74% females (n=23) and 26% males (n=8)] versus in the open group [40% females (n=17) and 60% males (n=26)] (p=0.003). There were more patients with malignant lesions in the open group (73%) versus in the laparoscopic group (45%) (p=0.01). Eight patients underwent partial and 23 patients segmental/wedge liver resection in the laparoscopic group versus 15 patients who underwent partial and 28 patients segmental/wedge liver resection in the open group (p=0.7). Mean tumor size was 3.9+/-0.4 cm in the laparoscopic group versus 4.2+/-0.3 cm in the open group (p=0.5). Ten (32%) out of 31 cases in the laparoscopic group were hand-assisted. Inflow occlusion was used in 1 case (3%) in the laparoscopic group versus 16 (37.2%) in the open group. Mean operating time was 201+/-15 min for the laparoscopic group and 172+/-12 min for the open group (p=0.1). Mean estimated blood loss during the procedure was 122.5+/-45.4 cc for the laparoscopic group and 299.6+/-33.6 cc for the open group (p=0.002). Surgical margin was similar for malignant cases in both groups. Mean hospital stay was 3.2+/-1.0 days for the laparoscopic group and 6.8+/-0.7 days for the open group (p=0.004). The incidence of postoperative complications was 13% (n=4) in the laparoscopic and 16% (n=7) in the open group (p=0.7). CONCLUSION: This study shows that, with a longer operative time, the laparoscopic approach, despite the learning curve, offers advantages regarding operative blood loss, postoperative analgesic requirement, time to regular diet, hospital stay, and overall cost compared with the open approach for minor liver resections.

Day of surgery admission--is this safe practise?

Day of surgery admission (DOSA) describes the process whereby patients are admitted to hospital and have surgery, on the same day. This is the current admission policy in our institution, for most elective Otolaryngology Head and Neck Surgery patients. We audited 75 consecutive patients admitted on the same day as surgery within our department between May 2006 and January 2007. Significant comorbidity was seen in 28 patients (37.3%). Preoperative investigations prior to surgery were conducted in 64 patients (85.3%). About 21 patients (28%) were delayed going to theatre and the average length of delay was 51 mins. Our cancellation rate was 5.3%. Hospital management have embraced the concept of DOSA in our institution without evaluating the risk to patients. If the DOSA policy is to continue it is imperative that an adequate preoperative assessment clinic is established to prevent negative outcomes for our patients.

Conservative management of vestibular schwannomas: third review of a 10-year prospective study.

Seventy-two patients with a unilateral vestibular schwannoma have been treated conservatively for a median of 121 months. They have been followed prospectively by serial clinical examination, MRI scans and audiometry. Twenty-five patients (35%, 95% CI: 24-47) failed conservative management and required active intervention during the study. No factors predictive of tumour growth or failure of conservative management could be identified. Seventy-five per cent of failures occurred in the first half of the 10-year study. The median growth rate for all tumours at 10 years was 1 mm/year (range -0.53-7.84). Cerebellopontine angle tumours grew faster (1.4 mm/year) than intracanalicular tumours (0 mm/year, P < 0.01); 92% had growth rates under 2 mm/year. Hearing deteriorated substantially even in tumours that did not grow, but did so faster in tumours that grew significantly (mean deterioration in pure tone average at 0.5, 1, 2 and 3 kHz was 36 dB; speech discrimination scores deteriorated by 40%). Patients who failed conservative management had clinical outcomes that were not different from those who underwent primary treatment without a period of conservative management.

Distribution of interstitial cells of Cajal and nitrergic neurons in normal and diabetic human appendix.

The objective of this study was to determine the distribution of enteric nerves and interstitial cells of Cajal (ICC) in the normal human appendix and in type 1 diabetes. Appendixes were collected from patients with type 1 diabetes and from non-diabetic controls. Volumes of nerves and ICC were determined using 3-D reconstruction and neuronal nitric oxide synthase (nNOS) expressing neurons were counted. Enteric ganglia were found in the myenteric plexus region and within the longitudinal muscle. ICC were found throughout the muscle layers. In diabetes, c-Kit positive ICC volumes were significantly reduced as were nNOS expressing neurons. In conclusion, we describe the distribution of ICC and enteric nerves in health and in diabetes. The data also suggest that the human appendix, a readily available source of human tissue, may be useful model for the study of motility disorders.

Conservative management of vestibular schwannomas - second review of a prospective longitudinal study.

Vestibular schwannomas have been traditionally managed with microsurgical removal and in recent years, stereotactic radiotherapy. However, there is a group of patients in whom a conservative management approach might represent a desirable alternative. The aim of this study was to determine the natural history and outcome following the conservative management of 72 patients with unilateral vestibular schwannomas. This is a prospective cohort review of a previously published group of patients [Clin. Otolaryngol. (2000) 25, 28-39] with unilateral vestibular schwannoma that were initially analysed at our institution in 1998 [Walsh R.M., Bath A.P., Bance M.L. et al., Clin. Otolaryngol. (2000) 25, 28]. The mean duration of follow-up was 80 months (range 52-242 months). All the patients in the study underwent serial magnetic resonance imaging (MRI) for assessment of tumour growth. Patients were deemed to have failed conservative management if there was evidence of rapid radiological tumour growth and/or increasing signs and symptoms, which necessitated active intervention. The mean tumour growth rate for the entire group at the second review was 1 mm/year (range -0.84-9.65 mm/year). The mean growth rate for cerebellopontine angle tumours (1.3 mm/year) was significantly greater than that of internal auditory canal (IAC) tumours (0 mm/year) (P = 0.005). The majority of tumours (87.14%) grew <2 mm/year. There was significant tumour growth seen in 38.9%, no or insignificant growth in 41.7%, and negative growth in 19.4%. Twenty-three patients (32%) failed conservative management at the second review. There was no difference in the outcome of these failed patients in comparison with patients who underwent primary treatment without a period of conservative management. The mean growth rate of tumours in patients that failed conservative management (3.1 mm/year) was significantly greater than that in patients who did not fail (0.2 mm/year) (P < 0.001). No factors predictive of tumour growth or failure of conservative management were identified. Hearing deterioration with pure tone averages (0.5, 1, 2, 3 kHz) and speech discrimination scores occurred irrespective of tumour growth. This prospective study further emphasizes the role of conservative management in selected cases of vestibular schwannomas. Tumours in this study confined to the IAC typically demonstrated minimal or no growth on serial MRI scanning. Regular follow-up with interval scanning is mandatory in all patients.

Laparoscopic splenectomy for lymphoproliferative disease.

BACKGROUND: Elective laparoscopic splenectomy (LS) achieves excellent results for benign hematologic diseases. The role of LS for hematologic malignancies is harder to define owing to associated splenomegaly and patient disease that may alter outcome. METHODS: Retrospective review of single institution experience 1996 through 2002. To limit variability of disease processes, only patients with immune thrombocytopenic purpura (ITP) and lymphoproliferative disease (LPD) were studied. RESULTS: A total of 211 LS have been performed, including 73 for LPD and 86 for ITP. Patients with LPD were significantly older, 61 vs 46 years p<0.001; male, 45 (62%) vs 33 (38%), p<0.001; and larger splenic weight, 680 vs 162 g, p<0.001. Fifty-nine patients (81%) with LPD were operated with standard LS with a conversion rate of 15%. Hand-assisted LS was performed in 14 patients (19%), and three were converted to open. Compared to ITP, patients with LPD had longer operative time, 148 vs 126 min, p<0001, and higher blood loss, 200 vs 100 cc, p = 0.004. There was one mortality (0.6%), and morbidity occurred in six patients (8%) with LPD and seven (8%) with ITP. The median length of stay was 3 days for LPD and 2 days for ITP, p = 0.03. Forty-six patients were principally operated for a diagnosis, and 27 (60%) were found to have lymphoma. CONCLUSIONS: LS can be performed safely in patients with LPD, and when used judiciously with hand-assisted techniques can be performed with low conversion and morbidity rates. Splenectomy plays an important role in establishing the diagnosis of lymphoma in LPD.

Imaging for the diagnosis and staging of periampullary carcinomas.

Multiple imaging modalities are available for investigating patients with a suspected periampullary neoplasm. The relative utility of each imaging modality is discussed regarding its role in diagnosis and staging. A general imaging approach to patients with a distal biliary obstruction also is presented.

Determination of intact splenic weight based on morcellated weight.

BACKGROUND: Comparisons of splenic size based on splenic weight are difficult after laparoscopic splenectomy, which results in a morcellated specimen. We report the results of a direct comparison between morcellated and intact splenic weights. METHODS: Porcine spleens were harvested via a midline laparotomy, and an intact splenic weight was obtained, which served as the control. The spleen then was placed into an impermeable retrieval bag and returned to the peritoneal cavity. A separate 10-mm incision was made and the spleen mechanically morcellated with a uterine forceps. This design most faithfully recreates the morcellation process during laparoscopic splenectomy in humans. The aggregate weight of the fragments was compared with intact splenic weight. RESULTS: Intact and morcellated weights were obtained from 58 porcine spleens. The mean intact splenic weight was 145 g, and the mean morcellated weight was 78 g. For a given morcellated weight achieved at laparoscopic splenectomy, an estimated intact weight can be determined by the following formula: intact weight (g) = morcellated weight (g) x 1.34 + 45. CONCLUSIONS: On the basis of our calculations, a normal spleen weighing 150 g would have a mean morcellated weight of 78 g, and splenomegaly (intact spleen weighing 250 g or more) would be defined by a morcellated weight exceeding 153 g.

Recurrence after laparoscopic ventral hernia repair.

BACKGROUND: Although the early results of laparoscopic ventral hernia repair have shown a low recurrence rate, there is a paucity of long-term data. This study reviews a single institution's experience with laparoscopic ventral hernia repair (LVHR). METHODS: We carried out a retrospective analysis of all LVHR performed at the Cleveland Clinic Foundation from January 1996 to March 2001. Recurrence rates were determined by physical exam or telephone follow-up. Factors predictive of recurrence were determined using Cox regression. RESULTS: Of 100 ventral hernias completed laparoscopically, 96 were available for long-term follow-up (average, 30 months; range 4-65). There were no deaths and major morbidity occurred in seven patients. Recurrences were identified in 17 patients. Nine recurrences occurred in the 1st postoperative year; however, hernia recurrence continued throughout the period of follow-up. Multivariate analysis showed that a prior failed hernia repair was associated with a more likely chance of another recurrence (65% vs 35%, odds ratio (OR) 3.6; p = 0.05) and that an increased estimated blood loss (106 cc vs 51 cc, OR 1.03; p = 0.005) predicted recurrence. Other variables, including body mass index (BMI) (32 vs 31 kg/m2, p = 0.38), defect size (115 cm2 vs 91 cm2; p = 0.23), size of mesh (468 cm2 vs 334 cm2, p = 0.19), type of mesh (p = 0.62), and mesh fixation (p = 0.99), did not predict recurrence. An additional 14 cases required conversion to an open operation, and seven of these cases (50%) had recurrence on long-term follow-up. CONCLUSION: Although LVHR remains the preferred method of hernia repair at our institution, this study documents a higher recurrence rate than many other short-term series. There results underscore the importance of long-term follow-up in assessing hernia surgery outcome.

Retained gallbladder/cystic duct remnant calculi as a cause of postcholecystectomy pain.

BACKGROUND: Pain following cholecystectomy can pose a diagnostic and therapeutic dilemma. We reviewed our experience with calculi retained in gallbladder and cystic duct remnants that present with recurrent biliary symptoms. METHODS: Over the last 6 years, seven patients were referred to us for the evaluation of recurrent biliary colic or jaundice. There were four men and three women ranging in age from 35 to 70 years. All seven had biliary pain similar to the symptoms that precede cholecystectomy; two of them also had also associated jaundice and one had pancreatitis. The time from cholecystectomy to onset of symptoms ranged from 14 months to 20 years (median, 8.5 Years). Four had undergone laparoscopic cholecystectomy and three had had an open cholecystectomy; none had an operative cholangiogram. RESULTS: Five of seven underwent diagnostic endoscopic retrograde cholangiography (ERC), which revealed obvious filling defects in the cystic duct or gallbladder remnant. The final patient was diagnosed by laparoscopic ultrasound after eight negative radiographic studies. Four patients underwent laparotomy and resection of a retained gallbladder and/or cystic duct. Two patients were treated with extracorporeal shock-wave lithotripsy (ESWL); one of them also required endoscopic biliary holmium laser lithotripsy. One patient underwent successful repeat laparoscopic cholecystectomy. There were no treatment-related complications. At a median follow-up of 11.5 months, all have achieved complete stone clearance and are asymptomatic. CONCLUSION: Retained gallbladder and cystic duct calculi can be a source of recurrent biliary pain, and a heightened suspicion may be required to make the diagnosis. This entity can be prevented by accurate identification of the gallbladder-cystic duct junction at cholecystectomy and by routine use of cholangiography. A variety of therapeutic options can be employed to obtain a successful outcome.

Laparoscopic vs open resection of gastric stromal tumors.

BACKGROUND: Gastric stromal tumors are rare neoplasms that may be benign or malignant. Given that malignant gastric stromal tumors rarely involve lymph nodes and require excision with negative margins, they appear amendable to laparoscopic excision. There are few reports of laparoscopic resection, and no comparisons have been done between laparoscopic and open surgery. This study compares the relative efficacy of the two approaches. METHODS: Between May 1994 and December 2000, 33 patients underwent 35 operations for gastric stromal tumors. Laparoscopic resections were performed in 21 patients; open resections were done in 12 patients. The medical records of the patients were reviewed retrospectively with regard to operating time, blood loss, length of stay, and clinical course. RESULTS: Patient demographics, tumor characteristics (mean tumor size, benign vs malignant), and presenting symptoms were similar for both groups. In the laparoscopic group, 15 wedge resections; three partial gastrectomies, and three transgastric needlescopic enucleations were performed. In the open group, six wedge resections, four antrectomies, and two partial proximal gastrectomies were performed. There were no significant differences in mean operative time (169 vs 160 min), mean estimated blood loss (106 vs 129 cc), or perioperative complication rate (9.5% vs 8.3%) between the laparoscopic and open groups, respectively. The mean length of stay was significantly less (p<0.05) in the laparoscopic group (3.8 vs 6.2 days). Average follow-up was 1.5 years. One patient in each group has died due to metastatic disease. There have been no trocar site recurrences. CONCLUSIONS: Laparoscopic resection of gastric stromal tumors is safe and appropriate. Tumor size, operating time, and estimated blood loss were equivalent to the open approach, and there was a statistically shorter hospital stay in the laparoscopic group.

Laparoscopic splenectomy.

BACKGROUND: Laparoscopic splenectomy is currently the procedure of choice for elective splenectomy. This study reviews the initial 100 laparoscopic splenectomies completed at the Cleveland Clinic Foundation. METHODS: A retrospective review of elective laparoscopic splenectomy was performed to assess clinical outcomes at the Cleveland Clinic Foundation. Patient demographics, preoperative diagnoses, operative characteristics, morbidity, and mortality were evaluated. RESULTS: Of the 169 elective splenectomies completed over a 4-year period from 1995 to 1999, 100 were attempted laparoscopically. The proportions of all splenectomies attempted laparoscopically by year were 17%, 38%, 75%, and 72%. Nearly 70% of splenectomies were performed for idiopathic thrombocytopenic purpura or malignancy. Overall, the mean blood loss was 181 ml, and the mean operative time was 170 min. Splenomegaly occurred in 31% of the patients and accounted for longer operative times. Three patients required conversion to an open procedure. Postoperative complications were seen in 13% of the patients. One patient died in the postoperative period from staphylococcal sepsis, giving a mortality rate of 1%. CONCLUSIONS: Laparoscopic splenectomy currently is the procedure of choice for elective splenectomy at our institution. As compared with traditional open splenectomy, laparoscopic splenectomy results in minimal morbidity even in the setting of splenomegaly.

Outcome of laparoscopic splenectomy based on hematologic indication.

BACKGROUND: Laparoscopic splenectomy is the procedure of choice for elective splenectomy at the Cleveland Clinic Foundation. Although the literature clearly documents the technical feasibility and safety of laparoscopic splenectomy, little data exists concerning the results of this procedure based on the hematologic indication for splenectomy. We sought to examine the clinical experience with laparoscopic splenectomy in a single institution, with particular attention to morbidity and clinical outcomes based on hematologic disease process. METHODS: This study retrospectively reviewed a consecutive series of laparoscopic splenectomies performed for nontraumatic, splenic pathology at the Cleveland Clinic Foundation from August 1995 to January 2001. Patient demographics, operative indications, morbidity, mortality, and clinical outcome were evaluated. Hematologic diagnostic groups were compared using Fisher's exact tests and Wilcoxon rank-sum tests. RESULTS: A total of 147 laparoscopic splenectomies were performed. Seven patients (5%) required conversion to open splenectomy. Indications for splenectomy included idiopathic thrombocytopenic purpura (ITP) in 65 patients, hematologic malignancy in 43 patients, autoimmune hemolytic anemia (AIHA) in 9 patients, thrombotic thrombocytopenic purpura (TTP) in 9 patients, splenomegaly in 5 patients, splenic cyst in 4 patients, splenic abscess in 3 patients, hereditary spherocytosis in 2 patients, splenic artery aneurysm in 2 patients, Felty's syndrome in 1 patient, myelofibrosis in 1 patient, and other in 3 patients. Accessory spleens were identified in 20 patients (14%). Postoperative complications occurred in 23 (16%) patients. Patients with ITP had significantly shorter operation times (134 vs 163 min; p = 0.001), decreased estimated blood loss (126 vs 307 ml; p = 0.001), decreased length of hospital stay (2.8 vs 4.6 days; p < 0.001), and less chance of conversion (0 vs 7; p = 0.02) than patients with any other diagnosis. A mean follow-up period of 20 +/- 14 months showed an 85% rate of remission for ITP, 89% for TTP, and 89% for AIHA. Patients with malignant disease had significantly larger spleens (822 vs 313 g; p < 0.001), more estimated blood loss (380 vs 168 ml; p = 0.04), and longer operative times (170 vs 142 min; p = 0.009), as compared patients treated for benign disease. However, the length of hospital stay (4.3 vs 3.6 days; p = 0.06) and complication rates (19% vs 14%; p = 0.08) were not significantly different between the two groups. CONCLUSIONS: When performed for ITP, laparoscopic splenectomy resulted in shorter operations, minimal blood loss, earlier discharge, no conversions, and excellent remission rates, as compared with other hematologic indications. Despite larger spleens, more blood loss, and longer operations in patients with hematologic malignancies, morbidity and length of hospital stay still were similar to those associated with benign indications for laparoscopic splenectomy. In conclusion, laparoscopic splenectomy is safe and efficacious for a multitude of benign and malignant hematologic indications, and our data compares favorably to those for open series.

Somatostatin therapy for glomus tumors: a report of two cases.

Glomus tumors of the head and neck are benign vascular lesions that often provide dilemmas in management. The presence of somatostatin receptors on the tumor cell surface has facilitated an additional imaging technique in the form of radiolabeled octreotide scanning. The use of the somatostatin analogue, octreotide, also provides a therapeutic option for inoperable or recurrent tumors. We present two patients, one with a surgically inaccessible tumor that recurred after primary radiotherapy and one who underwent incomplete resection because of the tumor's proximity to the internal carotid artery. Neither tumor has shown further growth 5 and 3 years after treatment with octreotide, respectively.

Pancreatic complications following laparoscopic splenectomy.

BACKGROUND: Laparoscopic splenectomy (LS) has been widely accepted despite a paucity of outcome data. Therefore, we performed a review of LS to assess the pancreatic complications and outcomes associated with this procedure. METHODS: Ninety-four splenectomies were performed for a variety of hematologic disorders. The patient was placed in the lateral position, and three or four trocars were used. RESULTS: LS was completed successfully in 93 patients. One case was converted to an open splenectomy for suspected gastrotomy. Thirty of 32 patients with splenomegaly underwent successful LS. Fifteen patients (16%) had some evidence of pancreatic injury. Six patients had asymptomatic hyperamylasemia. An injury directly associated with an adverse outcome occurred in nine cases (9.5% overall); six patients had pancreatic collections, one had a pancreatic fistula, and two developed hyperamylasemia and pain altering the length of hospitalization. Four of these nine patients did not have elevated postoperative amylase levels and were readmitted with pancreatic complications. CONCLUSIONS: LS can be performed for most pathologic conditions. Pancreatic injury is the most common morbidity associated with LS. The detection of hyperamylasemia can alert the surgeon to a pancreatic injury and alter postoperative management.