Stent treatment or surgical closure for perforated duodenal ulcers: a prospective randomized study.

BACKGROUND: Perforated peptic ulcer is a life-threatening condition. Traditional treatment is surgery. Esophageal perforations and anastomotic leakages can be treated with endoscopically placed covered stents and drainage. We have treated selected patients with a perforated duodenal ulcer with a partially covered stent. The aim of this study was to compare surgery with stent treatment for perforated duodenal ulcers in a multicenter randomized controlled trial. METHODS: All patients presenting at the ER with abdominal pain, clinical signs of an upper G-I perforation, and free air on CT were approached for inclusion and randomized between surgical closure and stent treatment. Age, ASA score, operation time, complications, and hospital stay were recorded. Laparoscopy was performed in all patients to establish diagnosis. Surgical closure was performed using open or laparoscopic techniques. For stent treatment, a per-operative gastroscopy was performed and a partially covered stent was placed through the scope. Abdominal lavage was performed in all patients, and a drain was placed. All patients received antibiotics and intravenous PPI. Stents were endoscopically removed after 2-3 weeks. Complications were recorded and classified according to Clavien-Dindo (C-D). RESULTS: 43 patients were included, 28 had a verified perforated duodenal ulcer, 15 were randomized to surgery, and 13 to stent. Median age was 77.5 years (23-91) with no difference between groups. ASA score was unevenly distributed between the groups (p = 0.069). Operation time was significantly shorter in the stent group, 68 min (48-107) versus 92 min (68-154) (p = 0.001). Stents were removed after a median of 21 days (11-37 days) without complications. Six patients in the surgical group had a complication and seven patients in the stent group (C-D 2-5) (n.s.). CONCLUSIONS: Stent treatment together with laparoscopic lavage and drainage offers a safe alternative to traditional surgical closure in perforated duodenal ulcer. A larger sample size would be necessary to show non-inferiority regarding stent treatment.

Hepatitis E virus genotype 3 is associated with gallstone-related disease.

Objective: Hepatitis E virus (HEV) genotype 3 is endemic in Northern Europe and despite a high seroprevalence of anti-HEV IgG antibodies among blood donors (≈17%), few clinical cases are notified in Sweden. Low awareness of hepatitis E and its possible symptoms may contribute to this discrepancy. The aim of this study was to investigate the prevalence of acute HEV infection among hospital admitted patients with abdominal pain and elevated liver enzymes.Materials and methods: During 2016-2017, 148 adult patients with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > twice normal levels were prospectively enrolled at surgical wards at three Swedish hospitals. Serum samples were analyzed for HEV RNA as well as anti-HEV IgM and IgG, and medical records were reviewed.Results: Six (6/148, 4.1%) patients were HEV infected confirmed by detectable HEV RNA, but only one of these patients had detectable anti-HEV antibodies. Four of the HEV infected patients were diagnosed with gallstone-related disease: three with biliary pancreatitis and one with biliary colic. The remaining two were diagnosed with bowel obstruction and pancreatic malignancy. Four HEV strains were typed by sequencing to genotype 3.Conclusions: This study identified acute HEV3 infection in 4% of the patients with elevated liver enzymes admitted to a surgical ward. HEV infection was not the solitary disease leading to hospitalization, instead it was found to be associated with other surgical conditions such as gallstone-related disease including biliary pancreatitis. Additionally, HEV RNA might be the preferential diagnostic tool for detecting ongoing HEV infection.

Stress response and well-being after open, laparoscopic, and NOTES transgastric uterine horn resection in a randomized porcine model.

BACKGROUND: NOTES is believed to induce less surgical trauma than open and laparoscopic surgery. The degree of surgical trauma can be assessed by measuring serum levels of acute-phase proteins such as CRP and TNF-α. We conducted a prospective randomized survival trial in which the inflammatory responses after laparoscopic, open, and NOTES transgastric uterine horn resection were compared. The aim of this study was to investigate whether NOTES procedures induce less inflammatory response. METHODS: Thirty pigs were randomized into three groups to undergo open, laparoscopic, or transgastric uterine horn resection. Weight, body temperature, and postoperative recovery were recorded and venous blood samples were taken for analysis of CRP and TNF-α at different time points. Analyses of CRP and TNF-α were performed using pig-specific ELISA assays. RESULTS: Procedure time was significantly longer for NOTES [median = 121 min (range = 94-155)] compared with that for open surgery [median = 22 min (14-27)] and laparoscopy [median = 37 min (20-45)] (p < 0.0001). There was a nonsignificant tendency for shorter recovery time for the NOTES animals. Twenty-seven animals survived for 4 weeks. One animal in each group was euthanized prior to 4 weeks. All animals gained weight during the 4-week period with no significant differences. Only animals in the NOTES group showed a significant weight gain during the first postoperative week (p = 0.007). On postoperative day (POD) 1, CRP was significantly lower in the NOTES group compared with the open and laparoscopic groups (mean = 0.72 ± 0.22, 0.98 ± 0.26, and 0.97 ± 0.20, respectively; p = 0.048). The CRP levels were normalized on day 14. Throughout the study there were no significant changes in TNF-α levels in the laparoscopic and NOTES groups. At POD 3 the open surgery group showed significantly higher TNF-α levels than the other groups (p = 0.036). CONCLUSIONS: Despite the longer operating time, the transgastric NOTES approach seems to be less traumatic than open or laparoscopic uterine horn resection in this porcine model.

A randomized trial comparing rates of abdominal contamination and postoperative infection among natural orifice transluminal endoscopic surgery, laparoscopic surgery, and open surgery in pigs.

BACKGROUND: Bacterial contamination of the abdominal cavity and infectious complications have been debated concerning transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures. OBJECTIVE: The aim of this study was to compare bacterial contamination of the abdominal cavity and clinically relevant infections after open, laparoscopic, and transgastric NOTES procedures. DESIGN: Randomized survival study in a porcine model. SETTING: Animal laboratory at a university hospital. INTERVENTION: Thirty pigs were randomized to open, laparoscopic, or transgastric NOTES uterine horn resection under sterile conditions. Bacterial cultures were obtained from the pelvic area immediately at entry of the abdominal cavity and just before closure. The left uterine horn was dissected and ligated. The animals survived for 4 weeks. At necropsy, bacterial culture was obtained from the pelvic area. MAIN OUTCOME MEASUREMENTS: Perioperative: operation time and incision length, bacterial growth in abdominal samples. Postoperative: infections or complications, weight gain. Necropsy: signs of peritonitis or infection, abdominal bacterial growth. RESULTS: Procedure time was significantly longer for transgastric NOTES. At the start of the procedure, 4 of the NOTES animals showed positive cultures, but only 1 showed positive cultures at the end. No open surgery or laparoscopic surgery animals showed positive cultures at these time points. At necropsy, none of the animals in the NOTES group showed bacterial growth, whereas 4 open surgery animals and 3 laparoscopic surgery animals had positive cultures. Four of these animals (2 from each group) had concurrent wound infections. LIMITATIONS: Small sample size and lack of power calculation. CONCLUSION: This study indicates that clinically relevant infections are rare after transgastric NOTES procedures despite evidence of bacterial contamination and longer operating times.

Stenting for colorectal cancer obstruction compared to surgery--a study of consecutive patients in a single institution.

BACKGROUND: Colonic obstruction is a common complication to colorectal cancer and surgical treatment is associated with high morbidity and mortality. Stenting has emerged as an alternative to surgery. The aim of this study was to compare short-term morbidity, mortality and hospital stay between treatment with self-expandable metallic stent and emergency surgery performed at our department during a 5-year period in a non-randomized setting. METHODS: Patients with colonic obstruction due to rectal or colon cancer referred to the Endoscopic Unit or Surgical Department for insertion of a colonic stent between 1 August 2003 and 1 August 2008 were prospectively registered and followed (n = 112). A control group was identified using the hospital records of operations with the International Classification Code-10 (ICD-10) for bowel obstruction and colorectal cancer (n = 60). Age, gender, indication, preoperative investigations, surgical procedure, complications and procedure-related mortality were registered. Patients were followed in accordance with local guidelines. RESULTS: The complication rate was similar in the two groups, although there was a trend toward a higher number of severe complications in the surgical group. The hospital stay was significantly lower in the stent group, median of 4 vs. 9 days (p < 0.0001). The procedure-related mortality was lower in the stent group; 7% vs. 20% (p < 0.05). CONCLUSIONS: Stenting can be safely performed with lower or similar complication rate and lower mortality rate compared to surgery and results in significantly shorter hospital stay. The results support stenting as the treatment of choice in patients with acute colonic obstruction, especially in disseminated disease.

New methods for innovation: the development of a toolbox for natural orifice translumenal endoscopic surgery (NOTES) procedures.

BACKGROUND: Devices used for flexible intralumenal procedures are inadequate when used for intraperitoneal surgical procedures such as cholecystectomy. OBJECTIVE: To assess/address limitations of flexible endoscopic devices in intraperitoneal surgery. DESIGN: To describe processes used to invent new devices to facilitate this new surgical genre. SETTING: Engineering laboratory. PATIENTS: None. INTERVENTIONS AND INVENTIONS: Reviews of the limitations of flexible endoscopic instruments and instrumentation/invention needs for a "NOTES cholecystectomy" were completed. MAIN OUTCOME MEASURES: The appropriateness of existing methods of device innovation was evaluated against an inventory of new technologies necessary to perform NOTES. The deficiencies in traditional innovation methods led to the creation of a novel process for invention of new medical devices: the "Inventorama." METHODS: Cooperation between clinicians and industry to develop device concepts to enable NOTES. RESULTS: The devices included: (1) steerable flex trocar, (2) rotary access needle, (3) bipolar hemostasis forceps, (4) Maryland dissectors, (5) articulating hook knife, (6) rotating hook knife, (7) articulating graspers, (8) scissors, (9) ligating clip applier, and (10) tissue apposition system. Six of these ten were built and tested as initial crude prototypes in the Inventorama process; two underwent major modifications. Three were invented via alternate methods, including by independent clinicians. CONCLUSIONS: A new method for efficient medical device invention and development was created to address key technology needs for NOTES. The result was a "toolbox" of devices designed to address the key surgical activities necessary for advanced intralumenal and translumenal flexible endoscopic procedures.

A randomized comparison of a new flexible bipolar hemostasis forceps designed principally for NOTES versus a conventional surgical laparoscopic bipolar forceps for intra-abdominal vessel sealing in a porcine model.

BACKGROUND: Current devices for hemostasis in flexible endoscopy are inferior to methods used during open or laparoscopic surgery and might be ineffective for natural orifice transluminal endoscopic surgery. OBJECTIVE: To compare new flexible bipolar forceps (FBF), designed principally for natural orifice transluminal endoscopic surgery, with laparoscopic bipolar forceps (LBF) for hemostasis of intra-abdominal porcine arteries. SETTING: Surgical laboratories in Europe and the United States. DESIGN AND INTERVENTIONS: New FBF for hemostasis (3.7-mm diameter), featuring electrode isolation, were compared with rigid 5-mm LBF (ERBE BiClamp LAP forceps) at recommended settings. A porcine model of acute hemostasis was prepared by suturing the uterine horns and cecum to the abdominal wall, exposing uterine arteries, ovarian pedicles, cecal mesenteric bundles, and the inferior mesenteric artery. This allowed access to 10 vessels in each pig by transabdominal laparoscopic devices or a transgastric double-channel gastroscope. Vessels were measured, coagulated at 4 and more points, and transected. Blood pressure was increased to more than 200 mm Hg for 10 minutes by administering phenylephrine. Delayed bleeding was identified. MAIN OUTCOME MEASUREMENTS: In 7 pigs, a total of 65 vessels (1.5-6.0 mm) were randomly allocated to FBF (n = 32) or LBF (n = 33). Successful hemostasis both before and after blood pressure increase was equivalent between the 2 groups (before: 88% FBF vs 88% LBF, not significant [NS]; after: 97% FBF vs 94% LBF, NS). With FBF, the number of seals per vessel was 4.8 vs 4.4 with LBF (NS). The energy used to create FBF seals was 19.8 J vs 38.2 J for LBF (P < .05). LIMITATIONS: Results from porcine studies may not reflect patient outcomes. CONCLUSIONS: In a porcine model, transgastric FBF endoscopic hemostasis was as effective as conventional laparoscopic hemostasis using LBF across a wide range of vessels.

Bacterial colonization of the stomach and duodenum in a Swedish population with and without proton pump inhibitor treatment.

BACKGROUND AND AIM: Microbial contamination of the abdominal cavity is a serious concern during transgastric endoscopic interventions and perforations, particularly in patients who have inhibited gastric acid secretion due to treatment with proton pump inhibitors (PPIs).The aim of this study was to investigate the gastric and duodenal bacterial flora in patients with and without PPI treatment. METHODS: Patients referred for gastroscopy, without recent antibiotic treatment, were eligible for inclusion. Use of PPIs was recorded. Samples for bacterial culturing were obtained from the antrum of the stomach and from the duodenal bulb through a gastroscope. Positive cultures were examined for bacterial types and subtypes. Biopsies were taken in the antrum for urease test to detect Helicobacter pylori. RESULTS: Bacterial cultures from the stomach were obtained from 103 patients, and duodenal samples were also cultured from 49 of them, for a total of 53 patients with PPI use and 50 patients without. Positive gastric cultures were found in 42 of 53 patients with PPI use and in 13 of 50 without (P < 0.0001). Duodenal cultures were positive in 20 of 24 with PPI and 8 of 25 without (P < 0.0001). The most commonly identified bacterial species were oral strains of Streptococcus, followed by Neisseria and Haemophilus influenzae. Of 103 patients, 10 had a positive urease test, indicating H. pylori infection, 1 with PPI and 9 without. CONCLUSIONS: Bacterial growth in the stomach and duodenum is more common in patients with PPI treatment. The dominating bacterial species found in the stomach and duodenum originates from the oropharynx. Clinical trials registry: Trial registration number 98041 in Researchweb (FoU in Sweden).

Endoscopic closure of colon perforation compared to surgery in a porcine model: a randomized controlled trial (with videos).

BACKGROUND: Endoscopic closure of inadvertent or intentional colon perforations might be valuable if comparable to surgical closure. OBJECTIVE: The aim of this study was to compare endoscopic closure of a 4-cm colon perforation in a porcine model with surgical closure in a multicenter study. SETTING: University hospitals in the United States and Europe. DESIGN AND INTERVENTIONS: After creating a 4-cm linear colon perforation, the animals were randomized to either endoscopic or surgical closure. The total procedure time from the beginning of perforation to the completion of procedure was measured. The animals were euthanized after 2 weeks to evaluate healing, unless there was a complication. RESULTS: Fifty-four animals were randomized to either surgical or endoscopic closure of colon perforation. Eight animals developed complications, and 7 of these were euthanized before 2 weeks. Twenty-three animals in each group survived for 2 weeks. Surgical closure of the perforation was successful in all animals in that group, and endoscopic closure was successful in 25 of the 27 animals. The median procedure time was shorter in the surgery group compared to the endoscopy group (35 vs 44 minutes, P = .016). Peritonitis, local adhesions, and leak test results were comparable in both groups. Distant adhesions were less frequent in the endoscopic closure group (26.1% vs 56.5%, P = .03). Five of the 186 T-tags (2.7%) were noted in the adjacent viscera. LIMITATION: This porcine study does not mimic clean colon perforation in humans; it mimics dirty colon perforation in humans. CONCLUSIONS: Endoscopic closure of a 4-cm colon perforation was comparable to surgery, and this technique can be potentially used for closure of intentional or inadvertent colon perforations.

Peritoneal and systemic pH during pneumoperitoneum with CO2 and helium in a pig model.

BACKGROUND: Local peritoneal effects of laparoscopic gases might be important in peritoneal biology during and after laparoscopic surgery. The most commonly used gas, CO(2), is known to be well tolerated, but also causes changes in acid-base balance. Helium is an alternative gas for laparoscopy. Although safe, it is not widely used. In this study a method for monitoring peritoneal pH during laparoscopy was evaluated and peritoneal pH during CO(2) and helium pneumoperitoneum was studied as well as its systemic reflection in arterial pH. METHODS: For these experiments 20 pigs were used, with ten exposed to pneumoperitoneum with CO(2), and ten to helium. Peritoneal and sub-peritoneal pH were continuously measured before and during gas insufflation, during a 30-minute period with a pneumoperitoneum and during a 30-minute recovery period. Arterial blood-gases were collected immediately before gas insufflation, at its completion, at 30 minutes of pneumoperitoneum and after the recovery period. RESULTS: Peritoneal pH before gas insufflation was in all animals 7.4. An immediate local drop in pH (6.6) occurred in the peritoneum with CO(2) insufflation. During pneumoperitoneum pH declined further, stabilising at 6.4, but was restored after the recovery period (7.3). With helium, tissue pH increased slightly (7.5) during insufflation, followed by a continuous decrease during pneumoperitoneum and recovery, reaching 7.2. Systemic pH decreased significantly with CO(2) insufflation, and increased slightly during helium insufflation. Systemic pH showed co-variation with intra-peritoneal pH at the the end of insufflation and after 30 minutes of pneumoperitoneum. CONCLUSIONS: Insufflation of CO(2) into the peritoneal cavity seemed to result in an immediate decrease in peritoneal pH, a response that might influence biological events. This peritoneal effect also seems to influence systemic acid-base balance, probably due to trans-peritoneal absorption.

Exploring pyloric dynamics in stenting using a distensibility technique.

BACKGROUND: Perforated duodenal ulcers can be treated with a covered stent. Stent migration is a severe complication, sometimes requiring surgery. Pyloric physiology during stent treatment has not been studied and mechanisms for migration are unknown. The aim of this study was to investigate the pyloric response to distention, mimicking stent treatment, using the EndoFLIP. METHODS: A nonsurvival study in five pigs was carried out, followed by a pilot study in one volunteer. Animals were gastroscoped during anaesthesia and the EndoFLIP was placed straddling the pylorus. Baseline distensibility readings were performed at stepwise balloon distentions to 20, 30, 40, and 50 mL, measuring pyloric cross-sectional area and pressure. Measurements were repeated after administration of a prokinetic drug and after a liquid meal. In the human study, readings were performed in conscious sedation at baseline and after stimulation with metoclopramide. KEY RESULTS: During baseline readings, the pylorus was shown to open more with increasing distention together with higher amplitude motility waves. Reaching maximum distention-volume (50 mL), pyloric pressure increased significantly (P = 0.016), and motility waves disappeared. After prokinetic stimulation, the pressure decreased and the motility waves increased in frequency and amplitude. After food stimulation, the pressure stayed low and the motility showed increase in amplitude. During both tests, the pylorus showed higher pressure and lack of motility waves at maximum probe distention. CONCLUSIONS AND INFERENCES: The pylorus seems to act as a sphincter at low distention but when further dilated starts acting as a pump. Fully distended the pyloric motility disappears and the pressure remains high, suggesting that a stent with high-radial force might show less migration.

Colonic obstruction caused by video capsule entrapment in a metal stent.

Video capsule endoscopy (VCE) has become the method of choice for visualizing the small bowel mucosa and is generally considered to be a safe method. Although uncommon, the most feared complication of VCE is capsule retention that can potentially lead to life-threatening bowel obstruction. Herein, we present for the first time a case of capsule retention in a colonic stent. The patient had known Crohn's disease with colonic involvement and underwent an uneventful but incomplete small bowel VCE for assessment of disease activity and extension for optimizing medical treatment. Five months later, the patient presented with intestinal obstruction due to a Crohn's-stricture in the sigmoid colon, which was successfully decompressed with a self-expandable metal stent. Nonetheless, two days later the patient showed signs of bowel obstruction again and abdominal X-ray showed that the capsule was trapped in the metal stent in the sigmoid colon. Subsequently, emergency surgery was performed and the patient fully recovered. Intestinal capsule retention necessitating interventional removal is rare. This report describes a unique case of capsule retention in a colonic metal stent and highlights the potential risk of performing capsule endoscopy examinations in patients with gastrointestinal stents.

Surgical Trauma Caused by Different Abdominal Access Routes-Comparison of Open Surgical, Laparoscopic, and NOTES Transgastric Techniques in a Porcine Model.

BACKGROUND: Investigations indicate that natural orifice translumenal endoscopic surgery (NOTES) procedures induce a less pronounced postoperative inflammatory response than open or laparoscopic surgery, inflicting less trauma. In NOTES procedures, no skin incision is performed. We compare the inflammatory response added by the type of incision by measuring C-reactive protein (CRP) and tumors necrosis factor-alfa (TNF-α). METHODS: Twenty-seven pigs were randomized to open surgical, laparoscopic, or transgastric NOTES abdominal access. After completion of the accesses, no surgery was performed. All accesses were left open for 40 minutes followed by closure, animals were survived for 7 days. Blood samples were drawn at the start of the accesses, at 20 and 40 minutes during the procedure, and at postoperative day (POD) 1, 3, and 7. Analyses of CRP and TNF-α were performed. RESULTS: CRP increased in all animals until POD1. This increase was greater in the open group (P = .006). No significant differences in CRP-levels were found at POD 1, 3, or 7. TNF-α showed a peak during the procedure, at 20 and 40 minutes, with normalization at POD1 for 1/3 of the open and laparoscopic animals, but not for the NOTES animals. Due to variations within the groups, no statistical difference was shown between them. At postmortem, 1/3 of the pigs in the laparoscopic and open groups had wound infections, while no NOTES animals showed infections. CONCLUSIONS: This study provides no statistically significant differences in inflammatory response after the different abdominal accesses. However, the lack of a TNF-α-peak in the NOTES group might indicate a less pronounced response, supporting the initial theories.

Development of a new access device for transgastric surgery.

Flexible endoscope-based endoluminal and transgastric surgery for cholecystectomy, appendectomy, bariatric, and antireflux procedures show promise as a less invasive form of surgery. Current endoscopes and instruments are inadequate to perform such complex surgeries for a variety of reasons: they are too flexible and are insufficient to provide robust grasping and anatomic retraction. The lack of support for a retroflexed endoscope in the peritoneal cavity makes it hard to reach remote structures and makes vigorous retraction of tissues and organs difficult. There is also a need for multiple channels in scopes to allow use of several instruments and to provide traction/countertraction. Finally, secure means of tissue approximation are critical. The aim was to develop and test a new articulating flexible endoscopic system for endoluminal and transgastric endosurgery. A multidisciplinary group of gastrointestinal physicians and surgeons worked with medical device engineers to develop new devices and instruments. Needs assessments and design parameters were developed by consensus. Prototype devices were tested using inanimate models until usable devices were arrived at. The devices were tested in nonsurvival pigs and dogs. The devices were accessed through an incision in the wall of the stomach and manipulated in the peritoneal cavity to accomplish four different tasks: right upper quadrant wedge liver biopsy, right lower quadrant cecal retraction, left lower quadrant running small bowel, and left lower quadrant exposure of esophageal hiatus. In another three pigs, transgastric cholecystectomy was attempted. The positions of the device, camera, and endosurgical instruments, with and without ShapeLock technology, were recorded using laparoscopy and endoscopy and procedure times and success rates were measured. Instrument design parameters and their engineering solutions are described. Flexible multilumen guides which could be locked in position, including a prototype which allowed triangulation, were constructed. Features of the 18-mm devices include multidirectional mid body and/or tip angulation, two 5.5-mm accessory channels allowing the use of large (5-mm) flexible endosurgical instruments, as well as a 4-mm channel for an ultraslim prototype video endoscope (Pentax 4 mm). Using the resulting devices, the four designated transgastric procedures were performed in anesthetized animals. One hundred percent of the transgastric endosurgical procedures were accomplished with the exception of a 50% success for hiatal exposure, a 90% success rate for wedge liver biopsy, and a 33.3% success rate for cholecystectomy. A new endosurgical multilumen device and advanced instrumentation allowed effective transgastric exploration and procedures in the abdominal cavity including retraction of the liver and stomach to allow exposure of the gallbladder, retraction of the cecum, manipulation of the small bowel, and exposure of the esophageal hiatus. This technology may serve as the needed platform for transgastric cholecystectomy, gastric reduction, fundoplication, hiatus hernia repair, or other advanced endosurgical procedures.

[Good results of stent treatment in perforated duodenal ulcer]. / Goda resultat av stentbehandling vid perforerat ulcus duodeni.

Despite modern treatment of ulcer disease perforations still occur and constitute a life threatening complication. Standard treatment is surgical closure. We have introduced stent treatment as a minimal invasive alternative, mainly in elderly and co-morbid patients. During a 4-year period (2009-2012) ten patients with perforated duodenal ulcer were treated with a covered duodenal stent at South Älvsborg Hospital. These patients were retrospectively compared with all patients (n = 19) treated with surgical closure at the same hospital during the same time period. Stent treatment shows good clinical results indicating fewer complications than surgical treatment even if the patients had a slightly higher ASA score. In this series stent treatment is shown to be a safe and effective alternative for treating perforated duodenal ulcers, even in old and co-morbid patients.

Endoscopic suturing.

We describe the development of endoscopic sewing machines and ancillary equipment for knot tying and thread cutting. We outline the experimental studies in dogs, pigs and baboons prior to the first studies in man. We consider the early results achieved by groups in Europe and the U.S.A., and present the available evidence from peer-reviewed studies and data from numerous abstracts on the use of endoscopic suturing in man for treating gastro-oesophageal reflux. We consider the limitations of the available studies, and outline the requirements for improvements in flexible endoscopic suturing methods.

Bard EndoCinch: the device, the technique, and pre-clinical studies.

There is, of course, room for improvement. More work is needed to make endoscopic suturing easier, quicker and more reliable. The single most important next goal is to construct a device, which can place multiple stitches without the need to remove the endoscope between each stitch. Devices, which can place two stitches in one go, would be a start. The development of double stitch and multiple stitch devices has been described earlier. The authors are pleased to see two alternative commercial endoscopic sewing devices appear at the last DDW which place two stitches without needing to withdraw the endoscopes--they use a double needle method.

A new in vivo method for testing closures of gastric NOTES incisions using leak of the closure or gastric yield as endpoints.

BACKGROUND: We developed a non-survival in vivo model for testing of gastric natural orifice translumenal endoscopic surgery (NOTES) closures based on the gastric yield pressure. The aim of this study was to test our model comparing different endoscopic closure techniques with surgical closure of a NOTES gastric incision. METHODS: Laparotomy was performed in 30 pigs. One tube for air inflation and one manometry tube were inserted into the stomach via the pylorus, which was closed gas-tight, and the abdominal wall was closed. The stomach was inflated with air, and the gastroesophageal yield pressure was measured. A gastroscopy was performed, and a standard NOTES access was created followed by randomization to closure by surgical suturing, T-tags, Padlock-G over-the-scope (OTS)-clips, OVESCO OTS-clips, and traditional clips. All closures were tested twice with air insufflation. Gastric yield pressure or leak pressure of each closure was recorded. RESULTS: The mean baseline gastric yield pressure was 80.5 mm Hg. Post-closure yield pressure was 79.9 mm Hg. Leak test results after closure were as follows: surgery, 0/6 leaked; T-tags, 1/6 leaked before reaching yield pressure (56 mm Hg); Padlock-G, 2/5 leaked (71.5 mm Hg); OVESCO OTS-clips, 3/6 leaked (27.2 mm Hg); and traditional clips, 5/6 leaked (27.2 mm Hg). TAS T-tags and surgical closures leaked significantly less than the other groups (P=.01). Traditional clips and OVESCO OTS-clips leaked at significantly lower pressures than the other three groups (P=.007). CONCLUSION: This in vivo model using leak of the closure or the gastric yield pressure as endpoints for testing of the closure strength of a NOTES gastric access site seems to be reproducible. Our results support closure with T-tags and Padlock-G-clips over OVESCO OTS-clips and standard endoscopic clips.

Endoscopic closure of transmural bladder wall perforations.

BACKGROUND: Traditionally, intraperitoneal bladder perforations caused by trauma or iatrogenic interventions have been treated by open or laparoscopic surgery. Additionally, transvesical access to the peritoneal cavity has been reported to be feasible and useful for natural orifice translumenal endoscopic surgery (NOTES) but would be enhanced by a reliable method of closing the vesicotomy. OBJECTIVE: To assess the feasibility and safety of an endoscopic closure method for vesical perforations using a flexible, small-diameter endoscopic suturing kit in a survival porcine model. DESIGN, SETTING, AND PARTICIPANTS: This pilot study was performed at the University of Minho, Braga, Portugal, using six anesthetized female pigs. INTERVENTIONS: Closure of a full-thickness longitudinal incision in the bladder dome (up to 10 mm in four animals and up to 20 mm in two animals) with the endoscopic suturing kit using one to three absorbable stitches. MEASUREMENTS: The acute quality of sealing was immediately tested by distending the bladder with methylene-blue dye under laparoscopic control (in two animals). Without a bladder catheter, the animals were monitored daily for 2 wk, and a necropsy examination was performed to check for the signs of peritonitis, wound dehiscence, and quality of healing. RESULTS AND LIMITATIONS: Endoscopic closure of bladder perforation was carried out easily and quickly in all animals. The laparoscopic view revealed no acute leak of methylene-blue dye after distension of the bladder. After recovery from anaesthesia, the pigs began to void normally, and no adverse event occurred. Postmortem examination revealed complete healing of vesical incision with no signs of infection or adhesions in the peritoneal cavity. No limitations have yet been studied clinically. CONCLUSIONS: This study demonstrates the feasibility and the safety of endoscopic closure of vesical perforations with an endoscopic suturing kit in a survival porcine model. This study provides support for further studies using endoscopic closure of the bladder which may lead to a new era in management of bladder rupture and adoption of the transvesical port in NOTES procedures.

Early clinical experience with a new flexible endoscopic suturing method for natural orifice transluminal endoscopic surgery and intraluminal endosurgery (with videos).

BACKGROUND: To perform advanced endoscopic treatments, one has to be able to close defects and perforations. Many devices have been constructed to perform endoscopic suturing, but all are rather complicated, expensive, and difficult to use. OBJECTIVE: To develop and use a new simple stitching technique at intraluminal flexible endoscopy. DESIGN: A flexible 19-gauge needle, loaded with a metal tag attached to a 3-0 polypropylene thread is passed down the working channel of a conventional endoscope. Two tags are placed into the stomach or the intestinal wall, 1 on each side of the defect. The threads are then locked together and cut. Precise stitch positioning is possible. Multiple stitches can be placed quickly, without removal of the endoscope. SETTING: Surgical department at Sahlgrenska University Hospital in Göteborg, Sweden. PATIENTS: Three patients in whom other conventional treatments had failed. INTERVENTIONS: Initially, survival studies in pigs were performed, and full-thickness resections, pyloroplasty, and gastrojejunostomies could be completed. The technique was subsequently used in patients when surgery was not feasible and when other endoscopic interventions had failed. MAIN OUTCOME MEASUREMENTS: Clinical evaluation; successful sealing of defects, leaks, or a bleeding vessel. RESULTS: We present 3 human cases and describe endoluminal closure of a perforated duodenal ulcer, a leaking gastroenteroanastomosis after gastroplasty, and successful treatment of upper-GI bleeding by oversewing a bleeding vessel. CONCLUSIONS: This stitching technique is easy to use and makes endoscopic suturing possible for closure of perforations and tissue approximation almost anywhere in the GI tract that can be reached by a flexible endoscope.