Daniel von Renteln

Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Prospective Single Center Study

OBJECTIVES:Endoscopic balloon dilatation and laparoscopic myotomy are established treatments for achalasia. Recently, a new endoscopic technique for complete myotomy was described. Herein, we report the results of the first prospective trial of peroral endoscopic myotomy (POEM) in Europe.METHODS:POEM was performed under general anesthesia in 16 patients (male:female (12:4), mean age 45 years, range 26–76). The primary outcome was symptom relief at 3 months, defined as an Eckhard score ≤3. Secondary outcomes were procedure-related adverse events, lower esophageal sphincter (LES) pressure on manometry, reflux symptoms, and medication use before and after POEM.RESULTS:A 3-month follow-up was completed for all patients. Treatment success (Eckhard score ≤3) was achieved in 94% of cases (mean score pre- vs. post-treatment (8.8 vs. 1.4); P<0.001). Mean LES pressure was 27.2 mm Hg pre-treatment and 11.8 mm Hg post-treatment (P<0.001). No patient developed symptoms of gastro-esophageal reflux after treatment, but one patient was found to have an erosive lesion (LA grade A) on follow-up esophagogastroduodenoscopy. No patient required medication with proton pump inhibitors or antacids after POEM.CONCLUSIONS:POEM is a promising new treatment for achalasia resulting in short-term symptom relief in >90% of cases. Studies evaluating long-term efficacy and comparing POEM with established treatments have been initiated.

Peroral Endoscopic Myotomy for the Treatment of Achalasia: An International Prospective Multicenter Study

Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97% of patients were in symptom remission (95% confidence interval, 89%-99%); symptom scores were reduced from 7 to 1 (P < .001) and lower esophageal sphincter pressures were reduced from 28 to 9 mm Hg (P < .001). The percentage of patients in symptom remission at 6 and 12 months was 89% and 82%, respectively. POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months.

Efficacy of Endoscopic Closure of Acute Perforations of the Gastrointestinal Tract

BACKGROUND & AIMS Acute perforations of the gastrointestinal tract are rare, severe complications of endoscopy that usually require surgical repair. Endoscopic repair of perforations would reduce the need for surgeries; we evaluated the efficacy and safety of endoscopic closure of acute perforations of the gastrointestinal tract by using a new clip device. METHODS We conducted a prospective, international, multicenter study of 36 consecutive patients (15 male) with acute iatrogenic perforations (5 esophageal, 6 gastric, 12 duodenal, and 13 colonic perforation). Endoscopic repair was performed by using the Over-the-Scope-Clip according to a standardized operating procedure. Primary end point was successful closure, which was determined as endoscopic successful closure without leakage (detected by water-soluble contrast x-ray analysis), and absence of adverse events within 30 days after the procedure. RESULTS Immediate closure was endoscopically successful in 33 patients (92%). One patient developed an esophageal perforation while the cap was introduced, and in 2 patients the perforations did not close; these 3 patients were successfully treated with surgery. None of the patients had leakage of soluble contrast on the basis of contrast x-ray. One patient with a closed colonic perforation deteriorated clinically within 6 hours after the procedure. Despite surgery, the patient died within 36 hours. The remaining 32 patients had successful endoluminal closures; the overall success rate was 89% (95% confidence interval, 75%-96%). The mean endoscopic closure time was 5 minutes 44 seconds ± 4 minutes 15 seconds. CONCLUSIONS The Over-the-Scope-Clip is effective for endoluminal closure of acute iatrogenic perforations. It allows patients to avoid surgery, and 89% of patients had successful closures without adverse events.

Endoscopic closure of GI fistulae by using an over-the-scope clip (with videos)

BACKGROUND Preclinical studies have demonstrated the over-the-scope clip (OTSC) to be feasible and safe for closure of gastric, duodenal, and colonic perforations. A retrospective clinical study demonstrated the feasibility and preliminary safety of the OTSC for the treatment of GI bleeding and closure of acute GI perforations. OBJECTIVE Because the OTSC allows rapid and easy endoscopic organ wall closure, we hypothesized that it might be a useful tool to close GI fistulae. DESIGN Case series. SETTING Academic medical center. PATIENTS Four consecutive patients with GI fistulae. INTERVENTIONS In all patients, a 12-mm OTSC, in combination with the dedicated twin grasper, anchor device, or endoscopic suction, was used to facilitate endoscopic closure. MAIN OUTCOME MEASUREMENTS In 2 cases, OTSCs allowed complete closure of a posttraumatic esophagopulmonary fistula and a chronic gastrocutaneous fistula. Leak tests and follow-up examination demonstrated complete leakproof closures. In 1 esophagopulmonary fistula and 1 jejunocutaneous fistula, the initial closure attempts using OTSCs were not successful because of chronic fibrotic changes and scarring at the fistula site. Both OTSCs were removed by using an endoscopic grasping forceps. The mean procedure time was 54 minutes (range 24-93 minutes). There were no procedure-related complications. LIMITATIONS Small sample size. CONCLUSIONS The OTSC seems to be a feasible device to close chronic fistulae of the GI tract. It can achieve leakproof, full-thickness closure of transmural defects. Nevertheless, in circumstances of severe fibrosis and scarring, complete incorporation of the defect into the applicator cap and successful OTSC application might not be possible.

Endoscopic full-thickness resection and defect closure in the colon

BACKGROUND Endoscopic full-thickness resection (eFTR) is a minimally invasive method for en bloc resection of GI lesions. OBJECTIVE The aim of this pilot study was to evaluate the feasibility of a grasp-and-snare technique for eFTR combined with an over-the-scope clip (OTSC) for defect closure. DESIGN Nonsurvival animal study. SETTING Animal laboratory. ANIMALS Fourteen female domestic pigs. INTERVENTIONS The eFTR was performed in porcine colons using a novel tissue anchor in combination with a standard monofilament snare and 14 mm OTSC. In the first group (n = 20), closure of the colonic defects with OTSC was attempted after the resection. In the second group (n = 8), an endoloop was used to secure the resection base before eFTR was performed. RESULTS In the first group (n = 20), eFTR specimens ranged from 2.4 to 5.5 cm in diameter. Successful closure was achieved in 9 out of 20 cases. Mean burst pressure for OTSC closure was 29.2 mm Hg (range, 2-90; SD, 29.92). Injury to adjacent organs occurred in 3 cases. Lumen obstruction due to the OTSC closure occurred in 3 cases. In the second group (n = 8), the diameter of specimens ranged from 1.2 to 2.2 cm. Complete closure was achieved in all cases, with a mean burst pressure of 76.6 mm Hg (range, 35-120; SD, 31). Lumen obstruction due to the endoloop closure occurred in one case. No other complications or injuries were observed in the second group. LIMITATIONS Nonsurvival setting. CONCLUSIONS Colonic eFTR using the grasp-and-snare technique is feasible in an animal model. Ligation of the resection base with an endoloop before eFTR seems to reduce complication rates and improve closure success and leak test results despite yielding smaller specimens.

Natural orifice transluminal endoscopic surgery gastrotomy closure with an over-the-endoscope clip: a randomized, controlled porcine study (with videos)

BACKGROUND Secure endoscopic closure of transgastric natural orifice transluminal endoscopic surgery (NOTES) access is of paramount importance. The over-the-scope clip (OTSC) system has previously been shown to be effective for NOTES gastrotomy closure. OBJECTIVE To compare OTSC gastrotomy closure with surgical closure. DESIGN Randomized, controlled animal study. SETTING Animal facility laboratory. ANIMALS Thirty-six female domestic pigs. INTERVENTIONS Gastrotomies were created by using a needle-knife and an 18-mm balloon. The animals were subsequently randomized to either open surgical repair with interrupted sutures or endoscopic repair with 12-mm OTSCs. In addition, pressurized leak tests were performed in ex vivo specimens of 18-mm scalpel incisions closed with suture (n = 14) and of intact stomachs (n = 10). MAIN OUTCOME MEASUREMENTS The mean time for endoscopic closure was 9.8 minutes (range 3-22, SD 5.5). No complications occurred during either type of gastrotomy closure. At necropsy, examination of all OTSC and surgical closures demonstrated complete sealing of gastrotomy sites without evidence of injury to adjacent organs. Pressurized leak tests showed a mean burst pressure of 83 mm Hg (range 30-140, SD 27) for OTSC closures and 67 mm Hg (range 30-130, SD 27.7) for surgical sutures. Ex vivo hand-sewn sutures of 18-mm gastrotomies (n = 14) exhibited a mean burst pressure of 65 mm Hg (range 20-140, SD 31) and intact ex vivo stomachs (n = 10) had a mean burst pressure of 126 mm Hg (range 90-170, SD 28). The burst pressure of ex vivo intact stomachs was significantly higher compared with OTSC closures (P < .01), in vivo surgical closures (P < .01), and ex vivo hand-sewn closures (P < .01). There was a trend toward higher burst pressures in the OTSC closures compared with surgical closures (P = .063) and ex vivo hand-sewn closures (P = .094). In vivo surgical closures demonstrated similar burst pressures compared with ex vivo hand-sewn closures (P = .848). LIMITATIONS Nonsurvival setting. CONCLUSION Endoscopic closure by using the OTSC system is comparable to surgical closure in a nonsurvival porcine model. This technique is easy to perform and is suitable for NOTES gastrotomy closure.

Feasibility and safety of EUS-guided cryothermal ablation in patients with locally advanced pancreatic cancer

BACKGROUND New therapies are needed for pancreatic cancer. OBJECTIVE To determine the feasibility and safety of a new endoscopic treatment. Secondary endpoints were to determine effects on tumor growth measured with CT scan and to find the overall survival. DESIGN A cohort study of patients with local progression of advanced pancreatic adenocarcinoma after neoadjuvant therapy. The cryotherm probe (CTP), a flexible bipolar device that combines radiofrequency with cryogenic cooling, was used under EUS guidance. SETTING San Raffaele Hospital, Milan, Italy; University Medical Center, Hamburg-Eppendorf, Germany. PATIENTS A total of 22 patients (male/female 11/11; mean age 61.9 years) were enrolled from September 2009 to May 2011. INTERVENTION Radiofrequency heating: 18 W; pressure for cooling: 650 psi (Pounds per Square Inch); application time: depending on tumor size. MAIN OUTCOME MEASUREMENTS Feasibility was evaluated during the procedure. A clinical and radiologic follow-up was planned. RESULTS The CTP was successfully applied in 16 patients (72.8%); in 6 it was not possible because of stiffness of the GI wall and of the tumor. Amylase arose in 3 of 16 patients; none had clinical signs of pancreatitis. Late complications arose in 4 cases: 3 were mostly related to tumor progression. Median postablation survival time was 6 months. A CT scan was performed in all patients, but only in 6 of 16 was it possible to clearly define the tumor margins after ablation. In these patients, the tumor appeared smaller compared with the initial mass (P = .07). LIMITATIONS Small sample of patients, difficulty of objectifying the size of the ablated zone by CT scan. CONCLUSION EUS-guided CTP ablation is feasible and safe. Further investigations are needed to demonstrate progression-free survival and local control.

Endoscopic closure of duodenal perforations by using an over-the-scope clip: a randomized, controlled porcine study

BACKGROUND Duodenal perforations during diagnostic upper endoscopy are rare; however, when therapeutic techniques are performed, the reported incidence is as great as 2.8%. Surgical repair is usually mandated, but it is associated with significant morbidity and mortality. OBJECTIVE To compare closure of duodenal perforations by using an over-the-scope clip (OTSC) with a surgical closure. DESIGN Randomized, controlled animal study. SETTING Animal facility laboratory. ANIMALS Domestic pigs (24 females). INTERVENTIONS Large (10-mm) duodenal perforations were created by using an endoscopic needle-knife. The animals were randomly assigned to either open surgical repair (n=12) or endoscopic closure by using the OTSC system (n=12). Pressurized leak tests were performed during necropsy. MAIN OUTCOME MEASUREMENTS One major bleed occurred because of a liver injury during creation of the duodenotomy. Mean time for endoscopic closure was 5 minutes (range, 3-8 min; SD +/- 2). No complications occurred during any of the closure procedures. At necropsy, all OTSC and surgical closures demonstrated complete sealing of duodenotomy sites. Pressurized leak tests demonstrated a mean burst pressure of 166 mm Hg (range, 80-260; SD +/- 65) for OTSC closures and 143 mm Hg (range, 30-300, SD +/- 83) for surgical sutures. Ex vivo intact duodenal specimens exhibited a mean burst pressure of 247 mm Hg (range, 200-300; SD +/- 35), which was significantly higher compared with in vivo OTSC and surgical closures (P < .01). There were no significant differences between burst pressures of OTSC and surgical closures (P = .461). LIMITATIONS Nonsurvival setting. CONCLUSIONS Endoscopic closure of duodenal perforations by using the OTSC system is comparable with surgical closure in a nonsurvival porcine model. This technique is easy to perform and seems suitable for repairing duodenal perforations.

Gastric full-thickness suturing during EMR and for treatment of gastric-wall defects (with video)

BACKGROUND The endoscopic full-thickness Plicator device was initially developed to provide an endoscopic treatment option for patients with GERD. Because the endoscopic full-thickness Plicator enables rapid and easy placement of transmural sutures, comparable with surgical sutures, we used the Plicator device for endoscopic treatment or prevention of GI-wall defects. OBJECTIVE To describe the outcomes and complications of endoscopic full-thickness suturing during EMR and for the treatment of gastric-wall defects. DESIGN A report of 4 cases treated with the endoscopic full-thickness suturing between June 2006 and April 2007. SETTING A large tertiary-referral center. PATIENTS Four subjects received endoscopic full-thickness suturing. The subjects were women, with a mean age of 67 years. INTERVENTIONS Of the 4 subjects, 3 received endoscopic full-thickness suturing during or after an EMR. One subject received endoscopic full-thickness suturing for treatment of a fistula. MAIN OUTCOME MEASUREMENTS Primary outcome measurements were clinical procedural success and procedure-related adverse events. RESULTS The mean time for endoscopic full-thickness suturing was 15 minutes. In all cases, GI-wall patency was restored or ensured, and no procedure-related complications occurred. All subjects responded well to endoscopic full-thickness suturing. LIMITATIONS The resection of one GI stromal tumor was incomplete. Because of the Plicators 60F distal-end diameter, endoscopic full-thickness suturing could only be performed with the patient under midazolam and propofol sedation. The durable Plicator suture might compromise the endoscopic follow-up after EMR. CONCLUSIONS The endoscopic full-thickness Plicator permits rapid and easy placement of transmural sutures and seems to be a safe and effective alternative to surgical intervention to restore GI-wall defects or to ensure GI-wall patency during EMR procedures.

Endoscopic full-thickness resection of gastric subepithelial tumors: a single-center series

BACKGROUND AND STUDY AIMS Endoscopic full-thickness resection of gastric subepithelial tumors with a full-thickness suturing device has been described as feasible in two small case series. The aim of this study was to evaluate the efficacy, safety, and clinical outcome of this resection technique. PATIENTS AND METHODS After 31 patients underwent endoscopic full-thickness resection, the data were analyzed retrospectively. Before snare resection, 1 to 3 full-thickness sutures were placed underneath each tumor with a device originally designed for endoscopic anti-reflux therapy. RESULTS All tumors were resected successfully. Bleeding occurred in 12 patients (38.7 %); endoscopic hemostasis could be achieved in all cases. Perforation occurred in 3 patients (9.6 %), and all perforations could be managed endoscopically. Complete resection was histologically confirmed in 28 of 31 patients (90.3 %). Mean follow-up was 213 days (range, 1 - 1737), and no tumor recurrences were observed. CONCLUSION Endoscopic full-thickness resection of gastric subepithelial tumors with the suturing technique described above is feasible and effective. After the resection of gastrointestinal stromal tumors (GISTs), we did not observe any recurrences during follow-up, indicating that endoscopic full-thickness resection may be an alternative to surgical resection for selected patients.