Safety analysis of a hemostatic powder in a porcine model of acute severe gastric bleeding.

BACKGROUND: Non-variceal upper gastrointestinal (UGI) bleeding is a common condition that requires prompt lifesaving therapy and traditional endoscopic treatments require high technical proficiency to perform. AIMS: This study was conducted to identify any local or systemic histopathologic effects of a hemostatic powder in a porcine model of active, severe, non-variceal UGI hemorrhage. METHODS: This prospective, non-blinded animal study was performed in accordance with Good Laboratory Practice and Animal Care and Use Guidelines. Six animals underwent gastrotomy and creation of a looped vascular bundle, which was placed into the stomach lumen. The transplanted vascular bundle was punctured with an endoscopic needle-knife to create Forrest grade Ia or Ib bleeding. The hemostatic powder was then applied until hemostasis was achieved. RESULTS: Initial hemostasis was achieved in all animals. Results of pre- and post-treatment coagulation studies were similar. All animals survived at least 9 days post-procedure. The hemostatic powder was not found in any local, regional, or systemic tissues. Gross and histologic analysis of systemic organs showed no infarct, particulate, or embolic effects. No gross or microscopic necropsy findings were treatment-related. CONCLUSIONS: The hemostatic powder achieved initial hemostasis (even in animals with spurting arterial bleeding) with no bowel obstruction or unintended luminal effects, no local or regional particulate effects, no systemic embolic effects, and no systemic coagulopathic effects.

Natural orifice translumenal endoscopic surgery for anterior spinal procedures.

Background. NOTES techniques allow transesophageal access to the mediastinum. The aim of this study was to assess the feasibility of transesophageal biopsy of thoracic vertebrae. Methods. Nonsurvival experiments on four 50-kg porcine animals were performed. Transesophageal access to the mediastinum was attained using submucosal tunneling technique. Results. The posterior mediastinum was successfully accessed and navigated in all animals. Vertebral bodies and intervertebral spaces were easily approached while avoiding damage to adjacent vessels. Bone biopsy was successfully performed without complications, but the hardness of bone tissue resulted in small and fragmented samples. Conclusions. Peroral transesophageal access into the posterior mediastinum and thoracic vertebral bone biopsy was feasible and safe. The proximity of the esophagus to the vertebral column provides close and direct access to the thoracic spine and opens up new ground for the performance of multilevel anterior spine procedures using NOTES techniques.

Endoscopic ultrasound (EUS)-guided pseudocyst drainage as a one-step procedure using a novel multiple-wire insertion technique (with video).

BACKGROUND: The EUS 2008 working group considered the development of equipment and methods to minimize the need for exchanging accessories and to facilitate insertion of multiple transmural stents during endoscopic ultrasound (EUS)-guided pseudocyst drainage as an important advance for therapeutic EUS. The authors aimed to describe their experience with EUS-guided pseudocyst drainage using a novel multiple-wire insertion technique facilitated by the double-lumen biliary cytology brush catheter. METHODS: The study enrolled 10 symptomatic patients undergoing EUS-guided pseudocyst drainage. The EUS-guided pseudocyst drainage was performed as a one-step procedure using graded catheter and balloon dilation of the cystgastrostomy tract and a novel multiple-wire insertion technique facilitated by a modified double-lumen biliary cytology brush catheter. The main outcome measured was technical success. RESULTS: In this study, 10 patients with 11 pseudocysts underwent a EUS-guided pseudocyst using the novel multiple-wire insertion technique. Technical success, defined as successful achievement of access and drainage of pseudocysts, was achieved in all cases (100 %) with no procedural complications. Clinical success was achieved in all cases with complete resolution of pseudocysts. CONCLUSIONS: The novel method of using a modified double-lumen biliary cytology brush catheter allows for a simple and safe one-step EUS-guided drainage of pseudocysts.

Dose-dependent depth of tissue injury with carbon dioxide cryotherapy in porcine GI tract.

BACKGROUND: Cryotherapy is a method of endoscopic mucosal ablation that involves delivery of a cryogen to result in tissue destruction by extreme low temperature. Its effects are influenced by the dosage of cryogen and thawing of ice. There are limited data on the tissue effects of multiple freeze and thaw cycles of carbon dioxide (CO(2)) cryotherapy on GI tissues. OBJECTIVE: To investigate the extent of tissue injury due to escalating doses of CO(2) cryotherapy on the esophagus, stomach, and colon of pigs. DESIGN: Animal experiment. INTERVENTION: Varying doses of CO(2) cryotherapy with increasing number of freeze-thaw cycles were applied to each site. The animals were allowed to survive for 48 hours. MAIN OUTCOME MEASUREMENTS: Depth of tissue injury assessed in blinded fashion by varying doses of cryotherapy on a defined area of porcine esophagus, stomach, and colon. RESULTS: There was a dose-dependent relationship of CO(2) cryogen and depth of injury (P = .0001 and P = .002, respectively). In the stomach, the dose-response relationship was significant (P = .007), but the average grades of injury across the various doses were lower when compared with the esophagus at comparable cryogen doses (P = .0004). The estimated depth of tissue injury from the mucosal surface in the porcine esophagus and colon tissue ranged from 1.2 to 2.5 mm and 1.3 to 2.5 mm, respectively. LIMITATIONS: The study was performed in a normal porcine model. CONCLUSION: There was a dose-dependent relationship between the dose of CO(2) cryotherapy and the depth of tissue injury in the porcine esophagus, stomach, and colon.

Double Hamoudi: A case report.

INTRODUCTION: Solid pseudopapillary neoplasms are rare pancreatic neoplasms with low malignant potential and favorable prognosis that are typically seen in young women. PRESENTATION OF CASE: We report a case of two large solid pseudopapillary neoplasms in a 23-year old woman who was treated successfully with a total pancreatectomy. CONCLUSION: To the best of our knowledge, this is the first report of two discrete solid pseudopapillary neoplasms in the same patient.

Clinical profile of autoimmune pancreatitis and its histological subtypes: an international multicenter survey.

OBJECTIVE: The objective of this study was to clarify the clinical and pathophysiological characteristics of autoimmune pancreatitis (AIP) and its subtypes (lymphoplasmacytic sclerosing pancreatitis [LPSP] and idiopathic duct-centric pancreatitis [IDCP]) seen around the world. METHODS: An international multicenter survey of AIP was conducted in 15 institutes from 8 countries. We compared clinical and pathologic profiles of AIP (n = 731) and the clinical profiles of LPSP (n = 204) and IDCP (n = 64) patients. RESULTS: Patients with LPSP were approximately 16 years older than IDCP patients. Obstructive jaundice was a more frequent presentation in LPSP versus IDCP (75% vs 47%, P < 0.001), whereas abdominal pain (41% vs 68%, P < 0.001) and acute pancreatitis (5% vs 34%, P < 0.001) were more frequent in IDCP patients. Patients with LPSP were more likely to have diffuse swelling of the pancreas (40% vs 25%, P = 0.037) and elevated serum IgG4 levels (63% vs 23%, P < 0.001) but less likely to be associated with ulcerative colitis (1% vs 16%, P < 0.001). Clinical profiles of non-histologically confirmed AIP from Asia, the United States, and United Kingdom corresponded with that of LPSP, whereas those from Italy and Germany suggested a mixture of LPSP and IDCP. CONCLUSIONS: Autoimmune pancreatitis is seen all around the world, with regional differences in the pathologic and clinical features. Lymphoplasmacytic sclerosing pancreatitis and IDCP have distinct clinical profiles.

Tumor size and location correlate with behavior of pancreatic serous cystic neoplasms.

OBJECTIVES: The majority of pancreatic serous cystic neoplasms (SCNs) are benign. However, these neoplasms can cause symptoms and rarely can be aggressive. Identification of factors associated with symptomatic or aggressive SCNs may aid management decisions. The aim of this study was to identify variables that predict aggressive SCNs. METHODS: Prospective pathology database was queried for SCNs that were surgically resected at Johns Hopkins Hospital. Tumors were considered aggressive if they invaded surrounding structures and/or vessels or if they metastasized to lymph nodes or distant organs. The associations of gender, tumor size, and tumor location, with the presence or absence of symptoms and tumor behavior were examined using Fisher's exact test, logistic regression, and multivariate analyses. RESULTS: A total of 257 patients with SCNs underwent surgical resection. Mean tumor diameter was 4.9 cm. Tumor location in the head of pancreas (HOP) was associated with symptoms (odds ratio (OR) 1.87, 95% confidence interval (CI) 1.1-3.3). Computed tomography (CT) predicted the diagnosis of SCN in approximately a quarter of patients. Thirteen tumors (mean 10.5 cm) were considered aggressive. Multivariate analysis showed that tumor diameter (OR 1.53, 95% CI 1.24-1.89) and location of tumor in pancreatic head (OR 10.44, 95% CI 1.73-63.04) were independently associated with aggressive behavior. CONCLUSIONS: We describe the largest case series of patients with pathologically proven SCNs. CT performed poorly in preoperative diagnosis of SCNs. Large tumor size and head location predicted aggressive behavior. These factors should be considered in the management of patients with SCN.

Autoimmune pancreatitis: current diagnostic criteria are suboptimal.

BACKGROUND AND AIMS: The preoperative diagnosis of autoimmune pancreatitis (AIP) is difficult, given its similar clinical presentation to pancreatic cancer. The aims of the study are to describe our center's experience with AIP and apply the Japanese AIP diagnostic criteria to a cohort of patients with histologically-proven AIP in order to assess their performance characteristics. METHODS: A prospective pathology database was queried for AIP patients who were evaluated and/or treated at Johns Hopkins Hospital from 2002 to 2009. AIP histology was defined by the presence of lymphoplasmacytic infiltration, periductal inflammation, fibrosis, and periphlebitis. Imaging, clinical, and biochemical data were analyzed. RESULTS: Thirty patients had pancreatic resection with pathological confirmation of AIP. Imaging revealed pancreatic mass (45%), focal prominence without mass lesion (24%), diffuse enlargement (17%), and normal pancreas (14%). Twenty-four patients underwent an endoscopic retrograde cholangiopancreatography and/or magnetic resonance cholangiopancreatography, and 4/24 (17%) had pancreatic ductal narrowing or irregularity. Extrapancreaticobiliary organ involvement was found in 6% (n = 2) of patients. Biliary strictures were present in 87% of patients. Of 16 patients who underwent preoperative tissue biopsy, 10 had non-diagnostic pathology, five had cellular atypia, and one had AIP. Serum immunoglobulin G4 (IgG4) levels were elevated in 12 of 29 (41%) patients. Three (10%) patients had evidence of extrapancreatic manifestations of AIP. When applying the Japanese criteria to the 27 patients who had serum IgG4 measurement, preoperative biopsy, and cross-sectional abdominal imaging, only 44% of the patients would have been diagnosed accurately. CONCLUSIONS: When applied to a highly-selected single-center referral population in the USA, current Japanese guidelines for the diagnosis of AIP are found to have suboptimal sensitivity.

EUS is still superior to multidetector computerized tomography for detection of pancreatic neuroendocrine tumors.

BACKGROUND: The role of EUS for detection of pancreatic neuroendocrine tumors (PNETs) is not clearly defined in institutions that use multidetector CT for pancreatic imaging. OBJECTIVE: The aims of this study were to (1) compare the detection rates of EUS and CT by type and size of PNET and calculate the incremental benefit of EUS over CT, (2) evaluate the CT detection rate for PNETs adjusted for improved CT technology over time, and (3) determine the factors associated with CT-negative PNETs. DESIGN: Retrospective single-center cohort study. SETTING: Johns Hopkins Hospital. PATIENTS: Patients with pathologically proven PNETs with preoperative CT. Incidentally found PNETs (resection specimens) and those without Johns Hopkins Hospital CT imaging were excluded. MAIN OUTCOME MEASUREMENT: Detection rates of CT and EUS were compared by using pathology as the reference standard. RESULTS: In 217 patients (with 231 PNETs) studied, CT detected 84% of tumors (54.3% of insulinomas). The sensitivity of CT for the detection of PNETs significantly increased with improvement in CT technology (P = .02; χ(2) for trend). CT was more likely to miss lesions <2 cm (P = .005) and insulinomas (P < .0001). In 56 patients who had both CT and EUS, the sensitivity of EUS was greater than CT (91.7% vs 63.3%; P = .0002), particularly for insulinomas (84.2% vs 31.6%; P = .001). EUS detected 20 of 22 CT-negative tumors (91%). LIMITATIONS: Retrospective nonrandomized design and referral bias. CONCLUSIONS: The detection rate of CT has significantly improved over time. CT-negative tumors are small and more likely to be insulinomas. A sequential approach of CT followed by EUS can detect most PNETs. EUS is a more sensitive initial test for the detection of suspected insulinomas.

EUS-guided tattooing before laparoscopic distal pancreatic resection (with video).

BACKGROUND: Precise localization of small pancreatic tumors during laparoscopic distal pancreatectomy (LDP) can be difficult because of decreased tactile ability of laparoscopy and the homogeneous appearance of the pancreas and surrounding retroperitoneal fat. Precise localization of the lesion is critical to achieving adequate margins of resection and preserving healthy pancreatic tissue. EUS-guided fine-needle tattooing (EUS-FNT) of a pancreatic lesion before LDP has been described in single case reports, but no large series have reported its effectiveness in patients undergoing LDP. OBJECTIVE: To assess the feasibility, safety, and efficacy of EUS-FNT in consecutive patients undergoing LDP. DESIGN: Retrospective cohort study. SETTING: Tertiary-care referral hospital. PATIENTS: This study involved 30 consecutive patients who underwent LDP from 2008 to 2010. Thirteen had EUS-FNT followed by LDP, and 17 had LDP alone. INTERVENTIONS: LDP or EUS-FNT with a sterile carbon-particle tattoo followed by LDP. MAIN OUTCOME MEASUREMENTS: The following features were examined: the technical success and complication rates of EUS-FNT, visibility of the tattoo at the time of laparoscopy, durability of the tattoo, and pathologic absence of tumor at the resection margin. RESULTS: The final pathology of pancreatic lesions of patients who had EUS-FNT was similar to those who had LDP alone. The median resected tumor size was significantly larger for the LDP-alone patients (median 4.0 cm vs 1.3 cm; P = .03). Thirty-one percent (4/13) of lesions in the EUS-FNT group were not visualized by prior preoperative pancreatic protocol CT. EUS-FNT was feasible in all 13 patients at laparoscopy, with R0 resection and negative final pathology margins in all cases. The tattoo was visible in all 13 EUS-FNT cases, with mean time from EUS-FNT to surgery of 20.3 days (range, 3-69 days). There were no significant complications associated with EUS-FNT. LIMITATIONS: Small, retrospective, single-center study. CONCLUSIONS: Preoperative EUS-FNT of lesions was technically feasible and safe, and it assisted in the localization of lesions in patients before LDP. The carbon particle tattoo was durable and visible in all cases.

Gastric wall healing after NOTES procedures: closure with endoscopic clips provides superior histological outcome compared with threaded tags closure.

BACKGROUND: Closure of the transgastric access to the peritoneal cavity is a critical step in natural orifice transluminal endoscopic surgery (NOTES). OBJECTIVE: To perform a direct comparison of the histological healing post clips and threaded tags (T-tags) closure after transgastric NOTES procedures. DESIGN AND INTERVENTION: Twelve survival porcine experiments. After standardized endoscopic gastric wall puncture, balloon-dilation, and transgastric peritoneoscopy, closure of the gastric wall was performed with either clips or T-tags. Necropsy at 14 days was performed for histological evaluation of 2-mm interval transversal cross sections of the gastrotomy site. MAIN OUTCOME MEASUREMENTS: Histological healing of the gastric wall opening. RESULTS: Endoscopic closure of the gastrotomy was successfully achieved in all 12 animals, followed by an uneventful 2-week clinical follow-up. Transmural healing was seen in 3 (75%) animals after clip closure compared with only 1 (12.5%) in the group with T-tag closure (P = .06). Gastric wall muscular bridging was observed in 4 (100%) animals with clip closure compared with only 1 (12.5%) in the group with T-tag closure (P = .01). LIMITATIONS: Animal model with short-term follow-up. CONCLUSIONS: Endoscopic clip closure results in a layer-to-layer transmural healing of the gastric wall. In contrast, T-tag gastric wall plication impairs gastric layer bridging. These findings might guide the future design of new endoscopic devices and techniques for gastrotomy closure after NOTES procedures.

A 2-microm continuous-wave laser system for safe and high-precision dissection during NOTES procedures.

INTRODUCTION: Lasers 2-microm in wavelength offer efficient tissue cutting with limited thermal damage in biological tissue. OBJECTIVE: To evaluate the dissection capabilities of a 2-microm continuous-wave laser for NOTES procedures. METHODS AND PROCEDURES: We conducted 18 acute animal experiments. Group 1 (three animals): transcolonic access to the peritoneal cavity (15-W transcolonic laser puncture, balloon dilation over the laser probe). Group 2 (six animals): transcolonic access with needle-knife puncture and balloon dilation. Group 3 (three animals): transgastric access to the peritoneal cavity (similar technique as group 1) followed by laser-assisted dissection of the kidney. In one animal of group 3, a therapeutic target (hematoma) was created by percutaneous puncture of the kidney. Group 4 (six animals): transgastric access (similar to the technique of group 2). RESULTS: Translumenal access to the peritoneal cavity was achieved in 2-3 min in group 1 (significantly shorter than with the needle-knife-assisted technique, 4-5 min, p=0.02) and in 7-10 min in group 3 (compared to 6-17 min in group 4, p=0.88). In group 3, laser dissection of the parietal peritoneum and of perinephric connective tissue allowed access to the retroperitoneum with complete removal of a blood collection in the animal with puncture trauma. Laser dissection demonstrated good maneuverability, clean and rapid cutting, and excellent hemostasis. Peritoneoscopy and necropsy showed no damage of targeted tissue and surrounding organs. CONCLUSIONS: The 2-microm continuous-wave laser system showed promising capabilities for highly precise and safe dissection during NOTES procedures.

A comparative evaluation of single-balloon enteroscopy and spiral enteroscopy for patients with mid-gut disorders.

BACKGROUND: Single-balloon enteroscopy (SBE) and spiral enteroscopy (SE) are recently described device-assisted techniques in endoluminal evaluation of the small bowel. No studies comparing SBE and SE in patients with suspected small-bowel disorders have previously been reported. OBJECTIVE: The aims of this study were to compare SBE and SE in terms of diagnostic yield, procedure time, depth of maximal insertion, and complications. DESIGN: Retrospective cohort study. SETTING: Tertiary-care referral center. PATIENTS: A retrospective analysis was performed on all patients at our institution undergoing anterograde SBE or SE between 2007 and 2009. Patients with altered anatomy or prior small-bowel surgery were excluded. INTERVENTION: Deep enteroscopy. MAIN OUTCOME MEASUREMENT: Diagnostic yield. RESULTS: During the study period, 92 patients underwent 105 procedures (52 SBE, 53 SE). The most common indication for small-bowel endoscopy was obscure GI bleeding (n = 42). The diagnostic yield was not statistically different between SBE and SE (59.6% and 43.4%, respectively, P = .12). The overall diagnostic yield in patients with obscure GI bleeding was 67%. There was no significant difference between mean SBE and SE procedure times (53 minutes [range 15-99 minutes] vs 47 minutes [range 20-125 minutes], respectively; P = .2). The mean depth of maximal insertion beyond the ligament of Treitz for SE was significantly higher than that for SBE (301 cm [range 175-400 cm] vs 222 cm [range 110-400 cm], respectively; P < .001). Perforation occurred in one SBE procedure. LIMITATIONS: Retrospective design and nonstandardized gas insufflation. CONCLUSION: This is the first report comparing SE and SBE. Although SE yielded greater depth of maximal insertion than SBE, both techniques had similar diagnostic yields and procedure times. In addition, both techniques were safe and were particularly useful in patients with obscure GI bleeding.

Preoperative endoscopic tattooing of pancreatic body and tail lesions decreases operative time for laparoscopic distal pancreatectomy.

BACKGROUND: Precise and expedient localization of small pancreatic tumors during laparoscopic distal pancreatectomy can be difficult owing to the decreased tactile ability of laparoscopy and the homogenous appearance of the surrounding retroperitoneal fat. Precise localization of the lesion is critical to achieving adequate margins of resection while preserving as much healthy pancreas as possible. The objective in this study was to determine the effect of endoscopic tattooing of the distal pancreas on operative time. METHODS: We reviewed retrospectively 36 consecutive patients who had a laparoscopic distal pancreatectomy at our institution over a 4-year period (2006-2009). Ten patients underwent preoperative tattooing via an endoscopic transgastric technique using ultrasound guidance. The tattoo was performed using 2-4 cc of sterile purified carbon particles injected immediately proximal and anterior to the pancreatic lesion. Operative times were compared according to the presence of a tattoo. RESULTS: The endoscopically placed tattoo was easily visible upon entering the lesser sac in all 10 patients at laparoscopy. Patients with a tattoo had a shorter operative time (median, 128.5 minutes; range, 53-180) compared with patients without a tattoo (median, 180 minutes; range, 120-240; P < .01). None of the tattoo group required repeat surgery, whereas 1 patient who was not tattooed required re-resection for a lesion missed in the initial specimen. There were no complications associated with the endoscopic ultrasound-guided tattoo. CONCLUSION: Endoscopic ultrasound-guided tattooing of pancreas lesions before a laparoscopic distal pancreatectomy is safe and is associated with decreased operative time compared with nontattooed patients. This technique can allow for quick and precise localization of the lesion, allowing for optimal preservation of pancreas parenchyma and demarcating an appropriate line of resection.

Gastric sarcoidosis: case report and literature review.

Sarcoidosis involving the gastrointestinal tract is extremely rare. Clinically recognizable gastrointestinal system involvement occurs in 0.1% to 0.9% of patients with sarcoidosis. We encountered a 22-year-old African American female admitted to Johns Hopkins Hospital (Baltimore, Maryland) for a 2-week history of fever, chills, eye pain, and abdominal pain. Her abdominal CT scan showed multiple subcentimeter retroperitoneal lymph nodes. An upper endoscopy was performed and discovered an antral nodule that measured about 7 mm and antral gastritis in which biopsies showed active chronic necrotizing granulomatous gastritis. Biopsies of the antral polyp showed focal intestinal metaplasia and active chronic necrotizing granulomatous pattern. Stains for Helicobacter pylori, acid fast, and fungi were negative. A small-bowel series showed no abnormality. Ophthalmologic evaluation revealed panuveitis with bilateral optic disc edema. The patient was later prescribed 60 mg of prednisone by mouth once a day and subsequently her abdominal pain and fever resolved during follow-up 2 months later. This literature review demonstrates the importance in the diagnosis, pathophysiology, clinical manifestations, types of gastric sarcoidosis, major endoscopic findings, and management of gastric sarcoidosis.

Infection during natural orifice transluminal endoscopic surgery: a randomized, controlled study in a live porcine model.

BACKGROUND: Currently reported natural orifice transluminal endoscopic surgery (NOTES) procedures in animals have been done in heterogeneous milieus ranging from nonsterile to sterile procedures, with mixed results, including no infection in those performed in nonsterile settings. OBJECTIVE: To establish the potential frequency of infection during NOTES, comparing sterile to nonsterile approaches. SETTING: Survival experiments on sixteen 50-kg pigs. DESIGN AND INTERVENTIONS: From pilot data (100% infection frequency after nonsterile procedures), sample size (8 animals in each group) was calculated by using a power of 95% and an alpha risk of 0.05. The animals were randomly assigned to two groups: In the transgastric peritoneoscopy study group, liver and ovarian biopsies were performed with sterile overtubes, endoscopes, and accessories and the use of preoperative intravenous antibiotics and antiseptic gastric lavage. In the nonsterile (control) group, the same procedures were performed with nonsterile endoscopes and accessories without the use of gastric lavage and preoperative antibiotics. Complete transmural closure of the transgastric access site was made in all animals. After a 1-week survival time, all animals were killed for necropsy, which included Gram staining and peritoneal cultures. MAIN OUTCOME MEASUREMENTS: Intraperitoneal infection on necropsy. RESULTS: All necropsies revealed intraperitoneal infection (abscesses, fibrinopurulent exudates, and adhesions) in the control group (frequency of infection 100%). Peritoneal bacterial culture grew various aerobic and anaerobic organisms. No gross or bacteriological evidence of infection was seen in the sterile group (frequency of infection 0%, P value = <.0002). LIMITATIONS: Animal experiments. CONCLUSION: Nonsterile conditions invariably lead to intraperitoneal infection. Aseptic techniques during NOTES can prevent intra-abdominal infection. Future studies will determine which infection prevention steps are mandatory and which can be omitted during NOTES procedures.

Patient- and cyst-related factors for improved prediction of malignancy within cystic lesions of the pancreas.

BACKGROUND AND AIMS: Early diagnosis of cancer in pancreatic cysts is important for timely referral to surgery. The aim of this study was to develop a predictive model for pancreatic cyst malignancy to improve patient selection for surgical resection. METHODS: We performed retrospective analyses of endoscopic ultrasound (EUS) and pathology databases identifying pancreatic cysts with available final pathological diagnoses. Main-duct intraductal papillary mucinous neoplasms (IPMNs) were excluded due to the clear indication for surgery. Patient demographics and symptoms, cyst morphology, and cyst fluid characteristics were studied as candidate risk factors for malignancy. RESULTS: 270 patients with pancreatic cysts were identified and analyzed (41% men, mean age 61.8 years). Final pathological diagnoses were branch-duct IPMN (n = 118, 50% malignant), serous cystadenoma (n = 71), pseudocyst (n = 37), mucinous cyst adenoma/adenocarcinoma (n = 36), islet cell tumor (n = 4), simple cyst (n = 3), and ductal adenocarcinoma with cystic degeneration (n = 1). Optimal cut-off points for surgical resection were cyst fluid carcinoembryonic antigen (CEA) > or =3,594 ng/ml, age >50, and cyst size >1.5 cm. Cyst malignancy was independently associated with white race (OR = 4.1, p = 0.002), weight loss (OR = 3.9, p = 0.001), cyst size >1.5 cm (OR = 2.4, p = 0.012), and high CEA > or =3,594 (OR = 5.3, p = 0.04). In white patients >50 years old presenting with weight loss and cyst size >1.5 cm, the likelihood of malignancy was nearly sixfold greater than in those patients who had none of these factors (OR = 5.8, 95% CI = 2.1-16.1, p = 0.004). CONCLUSIONS: Risk factors other than cyst size are important for determination of malignancy in pancreatic cysts. Exceptionally high cyst fluid CEA levels and certain patient-related factors may help to better predict cyst malignancy and the need for surgical treatment.

Successful diagnostic and therapeutic intrauterine fetal interventions by natural orifice transluminal endoscopic surgery (with videos).

BACKGROUND: Despite advances in the development of fetal surgery, morbidity and mortality are substantial. A natural orifice transluminal endoscopic surgery (NOTES)-guided approach to the gravid uterus may offer a less-invasive technique. OBJECTIVE: To assess the feasibility of NOTES for diagnostic and therapeutic intrauterine fetal interventions. SETTING: Survival and nonsurvival experiments on pregnant sheep. DESIGN AND INTERVENTION: Nonsurvival experiments performed in 2 pregnant sheep (80-110 days' gestation). A third ewe underwent NOTES and survived for 4 weeks. Transgastric (nonsurvival ewes) and transvaginal (1 nonsurvival and the survived ewe) peritoneoscopy was performed after standard needle-knife entry into the peritoneal cavity. Endoscopic access to the gravid uterus was assessed. EUS-guided, transuterine injection of saline solution into the fetal cardiac ventricle and vessels was attempted in all. MAIN OUTCOME MEASUREMENTS: Feasibility of NOTES- and EUS-guided intervention in a pregnant animal model, visibility of fetal parts via EUS compared with transabdominal US. RESULTS: Entry into the peritoneal cavity was achieved in each ewe. Access to and complete visualization of the gravid uterus were successful once within the abdominal cavity. Visualization of the fetal parts and the placental cotyledons by EUS was achieved in all animals. EUS-guided amniocenteses and transuterine intracardiac and intravascular injection of saline were successful. There were no complications or preterm delivery after the procedures. LIMITATIONS: Animal model. CONCLUSIONS: NOTES is technically feasible in the pregnant ewe. Intraperitoneal EUS via a NOTES approach provides excellent access and visualization of the intrauterine cavity and fetal parts.