Endoscopic therapy of upper gastrointestinal bleeding remains challenging with conventional endoscopic devices. Use of Hemospray, where a nanopowder with clotting abilities is sprayed onto the ...bleeding site, had been highly effective for management of arterial bleeding in a heparizined animal model. The safety and effectiveness of Hemospray for hemostasis of active peptic ulcer bleeding in humans was evaluated.
In a prospective, single-arm, pilot clinical study, consecutive adults with confirmed peptic ulcer bleeding (Forrest score Ia or Ib), who had all given informed consent to participation, underwent upper gastrointestinal endoscopy and application of Hemospray within 24 hours of hospital admission once hemodynamically stable. Up to two applications of Hemospray, not exceeding a total of 150 g were allowed. Bleeding recurrence was monitored post procedurally, by second-look endoscopy (72 hours post treatment), and by phone at 30 days. Rate of hemostasis, recurrent bleeding, mortality, need for surgical intervention, and treatment-related complications were assessed.
20 patients were recruited (18 men, 2 women; mean age 60.2 years). Acute hemostasis was achieved in 95 % (19 / 20) of patients; 1 patient had a pseudoaneurysm requiring arterial embolization. Bleeding recurred in 2 patients within 72 hours (shown by hemoglobin drop); neither had active bleeding identified at the 72-hour endoscopy. No mortality, major adverse events, or treatment- or procedure-related serious adverse events were reported during 30-day follow-up.
These pilot results indicate that Hemospray is safe in humans. Hemospray was effective in achieving acute hemostasis in active peptic ulcer bleeding.
Endoscopic therapy of brisk upper gastrointestinal bleeding remains challenging. A proprietary nanopowder (TC-325) has been proven to be effective in high pressure bleeding from external wounds. The ...efficacy and safety of TC-325 were assessed in a survival gastrointestinal bleeding animal model.
10 animals were randomized to treatment or sham. All animals received intravenous antibiotics, H2-blockers and heparin (activated clotting time 2 × normal). In a sterile laparotomy the gastroepiploic vessels were dissected, inserted through a 1-cm gastrotomy, and freely exposed in the gastric lumen, and the exposed vessel lacerated by needle knife. The treatment group received TC-325 by a modified delivery catheter while the sham group received no endoscopic treatment. Time to hemostasis, and mortality at 60 minutes, 24 hours, 48 hours, and 7 days were noted. Necropsy was performed in all animals.
Spurting arterial bleeding was achieved in all animals. No control animal showed hemostasis within the first hour compared with 100 % (5 / 5) in the treatment arm (mean 13.8 minutes, P < 0.0079). Durable hemostasis was achieved with no evidence of rebleeding after 1 and 24 hours in 80 % (4 / 5) of the treated animals compared with none in the control group ( P < 0.0098). None of the control animals survived more than 6 hours. Necropsy at 1 week in treated animals revealed healed gastrotomy without foreign body granuloma or embolization to the lung or brain.
TC-325 is safe and highly effective in achieving hemostasis in an anticoagulated severe arterial gastrointestinal bleeding animal model.
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.
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.
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.
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.
Fine optical coherence tomography (OCT) imaging needles that can be integrated with a standard biopsy needle have been developed with a new optics design to improve the optical quality and mechanical ...robustness, where a fiber-optic lens (that is spliced to a single-mode fiber) and a microreflector are encased within a microglass tube. The design also minimizes the cylindrical lens effect induced by the glass tube and eases the needle assembly process. Real-time cross-sectional OCT imaging of various tissue samples were performed ex vivo using the miniature-imaging needle along with a 1300-nm swept-source OCT system. The preliminary results demonstrate the improved mechanical and optical performance and suggest the potential of the fine OCT needle for minimally invasive interstitial imaging and image-guided biopsy.
Reliable closure of the transluminal incision is the crucial step for natural orifice transluminal endoscopic surgery (NOTES) procedures. The aim of this study was to evaluate the feasibility and ...effectiveness of transgastric access closure with a flexible stapling device in a porcine survival model.
We carried out four experiments (two sterile and two nonsterile) on 50 kg pigs. The endoscope was passed through a gastrotomy made with a needle knife and an 18-mm controlled radial expansion dilating balloon. After peritoneoscopy, a flexible linear stapling device (NOLC60, Power Medical Interventions, Langhorne, Pennsylvania, USA) was perorally advanced over a guide wire into the stomach, positioned under endoscopic guidance, and opened to include the site of gastrotomy between its two arms; four rows of staples were fired. One animal was sacrificed 24 hours after the procedure (progression of pre-existing pneumonia). The remaining animals were survived for 1 week and then underwent repeat endoscopy and postmortem examination.
Peroral delivery and positioning of the stapling device involved some technical difficulties, mostly due to the short length (60 cm) of the stapling device. The stapler provided complete leak-resistant gastric closure in all pigs. None of the surviving animals had any clinical signs of infection. Necropsy demonstrated an intact staple line with full-thickness healing of the gastrotomy in all animals. Histologic examination confirmed healing, but also revealed intramural micro-abscesses within the gastric wall after nonsterile procedure.
Gastrotomy closure with a perorally delivered flexible stapling device created a leak-resistant transmural line of staples followed by full-thickness healing of the gastric wall incision. Increasing the length of the instrument and adding device articulation will further facilitate its use for NOTES procedures.
Africa's economic transformation relies on a radical transformation of its higher education institutions. The establishment of regional higher education Centres of Excellence (CoE) across Africa ...through a World Bank support aims to stimulate the needed transformation in education and research. However, excellence is a vague, and often indiscriminately used concept in academic circles. More importantly, the manner in which aspiring institutions can achieve academic excellence is described inadequately. The main objective of this paper is to describe the core processes of excellence as a prerequisite to establishing academic CoE in Africa.
The paper relies on our collaborative discussions and real-world insight into the pursuit of academic excellence, a narrative review using Pubmed search for a contextual understanding of CoEs in Africa supplemented by a Google search for definitions of CoEs in academic contexts.
We identified three key, synergistic processes of excellence central to institutionalizing academic CoEs: participatory leadership, knowledge management, and inter-disciplinary collaboration. (1) Participatory leadership encourages innovations to originate from the different parts of the organization, and facilitates ownership as well as a culture of excellence. (2) Centers of Excellence are future-oriented in that they are constantly seeking to achieve best practices, informed by the most up-to-date and cutting-edge research and information available. As such, the process by which centres facilitate the flow of knowledge within and outside the organization, or knowledge management, is critical to their success. (3) Such centres also rely on expertise from different disciplines and 'engaged' scholarship. This multidisciplinarity leads to improved research productivity and enhances the production of problem-solving innovations.
Participatory leadership, knowledge management, and inter-disciplinary collaborations are prerequisites to establishing academic CoEs in Africa. Future studies need to extend our findings to understand the processes key to productivity, competitiveness, institutionalization, and sustainability of academic CoEs in Africa.
Background
Reliable closure of the translumenal incision is one of the main challenges facing natural orifice translumenal endoscopic surgery (NOTES). This study aimed to evaluate the use of an ...automated flexible stapling device (SurgASSIST) for closure of the gastrotomy incision in a porcine model.
Methods
A double-channel gastroscope was advanced into the stomach. A gastric wall incision was made, and the endoscope was advanced into the peritoneal cavity. After peritoneoscopy, the endoscope was withdrawn into the stomach. The SurgASSIST stapler was advanced orally into the stomach. The gastrotomy edges were positioned between the opened stapler arms using two endoscopic grasping forceps. Stapler loads with and without a cutting blade were used for gastric closure. After firing of the stapler to close the gastric wall incision, x-ray with contrast was performed to assess for gastric leakage. At the end of the procedure, the animals were killed for a study of closure adequacy.
Results
Four acute animal experiments were performed. The delivery and positioning of the stapler were achieved, with technical difficulties mostly due to a short working length (60 cm) of the device. Firing of the staple delivered four rows of staples. Postmortem examination of pig 1 (when a cutting blade was used) demonstrated full-thickness closure of the gastric wall incision, but the cutting blade caused a transmural hole right at the end of the staple line. For this reason, we stopped using stapler loads with a cutting blade. In the three remaining animals (pigs 2–4), we were able to achieve a full-thickness closure of the gastric wall incision without any complications.
Conclusions
The flexible stapling device may provide a simple and reliable technique for lumenal closure after NOTES procedures. Further survival studies are currently under way to evaluate the long-term efficacy of gastric closure with the stapler after intraperitoneal interventions.
The peroral transgastric endoscopic approach for intraabdominal procedures appears to be feasible, although multiple aspects of this approach remain unclear. This study aimed to measure ...intraperitoneal pressure in a porcine model during the peroral transgastric endoscopic approach, comparing an endoscopic on-demand insufflator/light source with a standard autoregulated laparoscopic insufflator.
All experiments were performed with 50-kg female pigs under general anesthesia. A standard upper endoscope was advanced perorally through a gastric wall incision into the peritoneal cavity. The peritoneal cavity was insufflated with operating room air from an endoscopic light source/insufflator. Intraperitoneal pressure was measured by three routes: (1) through the endoscope biopsy channel, (2) through a 5-mm transabdominal laparoscopic port, and (3) through a 16-gauge Veress needle inserted into the peritoneal cavity through the anterior abdominal wall. The source of insufflation alternated between on-demand manual insufflation through the endoscopic light source/insufflator using room air and a standard autoregulated laparoscopic insufflator using carbon dioxide (CO(2)).
Six acute experiments were performed. Intraperitoneal pressure measurements showed good correlation regardless of measurement route and were independent of the type of insufflation gas, whether room air or CO(2). On-demand insufflation with the endoscopic light source/insufflator resulted in a wide variation in pressures (range, 4-32 mmHg; mean, 16.0 +/- 11.7). Intraabdominal pressures using a standard autoregulated laparoscopic insufflator demonstrated minimal fluctuation (range, 8-15 mmHg; mean, 11.0 +/- 2.2 mmHg) around a predetermined value.
Use of an on-demand unregulated endoscopic light source/insufflator for translumenal surgery can cause large variation in intraperitoneal pressures and intraabdominal hypertension, leading to the risk of hemodynamic and respiratory compromise. Safety may favor well-controlled intraabdominal pressures achieved with a standard autoregulated laparoscopic insufflator.
The peroral transluminal approach to the peritoneal cavity appears safe, feasible, and may further reduce the invasiveness of surgery. However, flexible endoscopes have multiple limitations inside ...the peritoneal cavity, which can potentially be overcome by blending the use of both a laparoscope and a flexible upper endoscope--a hybrid approach. The goal of the present study was to evaluate a hybrid minimally invasive technique for cholecystectomy in a porcine model.
Hybrid cholecystectomies were performed in acute experiments on 50-kg pigs under general anesthesia. Pneumoperitoneum was created with a Veress needle, and a laparoscopic 10-mm port was inserted. Under laparoscopic observation, the gastric wall incision was done with an endoscopic needle-knife and sphincterotome, and the upper endoscope was advanced into the peritoneal cavity. A laparoscopic 10-mm port was inserted into the right upper quadrant of the abdomen for gallbladder traction to facilitate exposure of the cystic duct and artery. Via the biopsy channel of the flexible endoscope, and using a knife with an isolated tip, a needle knife, and clips, both the cystic duct and artery were identified, clipped, and transected. The gallbladder itself was then dissected and retracted through the mouth, and the gastric wall incision was closed with endoscopic clips.
Five hybrid cholecystectomies were performed without complications. The laparoscopic port enabled a stable pneumoperitoneum, good traction and counter-traction, and improved spatial orientation and visualization. Necropsy did not reveal any intraperitoneal complications.
The hybrid approach increases safety of initial gastric puncture and gastric wall incision, improves orientation and navigation of the flexible endoscope inside the peritoneal cavity, simplifies peroral transgastric cholecystectomy, and could be used to decrease invasiveness of laparoscopic surgery and to facilitate development and clinical introduction of transgastric endoscopic procedures.
The online version of this article (doi:10.1007/s00464-007-9329-2) contains supplementary material, which is available to authorized users.
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