Rogier P. Voermans

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.

In vitro comparison and evaluation of seven gastric closure modalities for natural orifice transluminal endoscopic surgery (NOTES)

BACKGROUND AND STUDY AIMS Secure transluminal closure is the most fundamental prerequisite for the safe introduction of natural orifice transluminal endoscopic surgery (NOTES). The aim was to compare acute strength of various gastrotomy closure techniques in an in vitro porcine stomach model by assessing leak pressures. METHODS Standardized gastrotomies were closed manually, without the use of an endoscope, by one of seven NOTES closure devices: (i) T tags, (ii) purse string modified T tags, (iii) Eagle Claw VIII, (iv) Resolution clips, (v) flexible stapler; (vi) purse string suturing device, and (vii) flexible Endostitch. After closure, each specimen was fixed on the experimental apparatus and the pressure was gradually increased. By linking the pressure gauge and two cameras, the leak location and pressure could be determined in detail. We began by collecting gold standard reference values, by testing 15 gastrotomies closed with interrupted surgical sutures; these were associated with a mean leak pressure of 206 mmHg (SD 59). Using a noninferiority design, a sample size of 11 specimens for each NOTES closure technique was determined. RESULTS The Resolution clips ( P = 0.0285), Eagle Claw VIII ( P = 0.0325), flexible stapler ( P < 0.001) and flexible Endostitch ( P = 0.002) produced noninferior closures in comparison with the predetermined gold standard; T tags ( P > 0.6775), purse string modified T tags ( P > 0.999), and the purse string suturing device ( P = 0.9875) resulted in inferior closures. CONCLUSIONS The Eagle Claw VIII, Resolution clips, flexible stapler and flexible Endostitch produced noninferior closures in comparison with surgical closure in this model. These techniques seem to be the prime candidates for further testing in animal experiments before human trials can be initiated.

Novel over-the-scope-clip system for gastrotomy closure in natural orifice transluminal endoscopic surgery (NOTES): an ex vivo comparison study

BACKGROUND AND STUDY AIMS Secure transluminal closure remains a fundamental barrier to clinical introduction of natural orifice transluminal endoscopic surgery (NOTES). Current NOTES closure modalities either do not provide secure closure or are too challenging to apply in vivo. The aims of this study were to evaluate gastric closure using the over-the-scope clip (OTSC) system in a previously described experimental setup, comparing the acute strength with a gold standard (hand surgical suturing). METHODS Comparison was done using an ex vivo porcine stomach experimental setup. The gastric opening was created by a needle knife puncture followed by dilation with 18-mm balloon. Control gastrotomies (n = 15; surgical suturing) showed a mean leak pressure of 206 mmHg (SD 59). A noninferiority design required a sample size of 11 specimens for the OTSC group. Closure comprised: (i) approximation of muscular layers using a flexible twin grasper; (ii) pulling the tissue into the OTSC cap at the tip of the scope; (iii) releasing the clip. Main outcome measures were leak pressure of closed gastrotomies, leak location, and time needed for adequate closure. RESULTS Closure was successful in all specimens in a median of 3 minutes. Closed gastrotomies showed air leakage at mean pressure of 233 mmHg (SD 47), which was non-inferior compared with the predetermined gold standard (P = 0.003). CONCLUSIONS Closure of gastric incisions to meet a predetermined leak pressure criterion was attainable and easy with the OTSC system. In vivo survival animal experiments are needed to further evaluate this promising closure modality.

Forward-viewing versus oblique-viewing echoendoscopes in transluminal drainage of pancreatic fluid collections: a multicenter, randomized, controlled trial

BACKGROUND EUS-guided drainage of pancreatic fluid collections (PFCs) is commonly performed with oblique-viewing echoendoscopes. However, accessing the PFC under an oblique angle can make drainage difficult. These difficulties might be overcome by using a forward-viewing echoendoscope. OBJECTIVE To compare endoscopic PFC drainage with an oblique-viewing versus a forward-viewing echoendoscope with emphasis on ease of endoscopic drainage. DESIGN Multicenter, randomized, controlled trial. SETTING Four tertiary-care referral centers. PATIENTS This study involved 58 patients with PFCs. INTERVENTION Patients with PFCs (≥ 6 cm) in whom drainage was indicated were randomized to receive EUS-guided drainage with a forward-viewing echoendoscope or an oblique-viewing echoendoscope. In cases of failed drainage, patients were crossed over to the other study arm. MAIN OUTCOME MEASUREMENTS Ease of EUS-guided drainage measured by procedure time. Secondary endpoints included technical success, EUS endoscope preference, clinical success, and adverse events. RESULTS Fifty-eight consecutive patients underwent randomization, of whom 52 were available for primary endpoint analysis. All 26 EUS-guided procedures done with the oblique-viewing echoendoscope and 24 of the 26 procedures done with the forward-viewing echoendoscope were technically successful. Mean (± standard deviation) procedure time was 24:55 ± 9:58 minutes in the forward-viewing echoendoscope group and 27:04 ± 9:58 minutes in the oblique-viewing echoendoscope group (P = .44). Median overall procedure ease was graded as equal (easy) in both groups. Drainage-related adverse events occurred in 2 patients (8%) in the forward-viewing echoendoscope group versus none in the oblique-viewing echoendoscope group (P = .56). Overall clinical success was achieved in 82% of patients (95% confidence interval, 69%-91%). LIMITATIONS Derived main outcome parameter and highly specialized endoscopists in tertiary-care referral centers. CONCLUSION This multicenter, randomized, controlled trial comparing the performance of oblique-viewing echoendoscopes and forward-viewing echoendoscopes in draining PFCs did not show a difference in ease of EUS-guided drainage or procedure safety and efficacy between the forward-viewing echoendoscope and the oblique-viewing echoendoscope. Clinical success was achieved in 82% of patients.

Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study.

BACKGROUND Palliation of malignant gastric outlet obstruction remains challenging. Although there are 2 established treatment options, ie, surgical gastrojejunostomy and endoscopic duodenal stent insertion, there is an ongoing search for a technique that would combine the safety and rapid effect of duodenal stent placement with the long-term efficacy and low reintervention rate of a surgical gastrojejunostomy. OBJECTIVE To investigate the safety and success rate of endoscopic creation of a gastroenteric anastomosis formed by magnetic compression and stent placement. DESIGN Prospective, multicenter cohort study. SETTING Four referral centers. PATIENTS The expected number of patients with symptomatic malignant gastric outlet obstruction to be included at the participating hospitals during a year was 40. Because of a serious adverse device event, the study was terminated after inclusion of 18 patients. INTERVENTION Creation of an endoscopic gastroenteric anastomosis by using the Cook Magnetic Anastomosis Device with transanastomotic deployment of a self-expandable stent. MAIN OUTCOME MEASUREMENTS Primary endpoints were safety and success rate associated with the creation of an endoscopic gastrojejunostomy by using a magnetic anastomotic device with transanastomotic deployment of a self-expandable stent. RESULTS Because of a serious adverse event, the study was terminated prematurely. A success rate of 66.7% (12 of 18 patients) was achieved; 1 serious adverse event (stent perforation) occurred leading to the death of the patient. Three patients (25%) experienced an adverse device effect (stent migration). LIMITATIONS Small sample size, lack of a control group. CONCLUSION Endoscopic creation of a gastroenteric anastomosis by magnetic compression is feasible and safe; however, the necessity of a stent led to serious morbidity and even mortality in this study. The current system can therefore not be recommended for clinical use.

Comparison of endoscopic closure modalities for standardized colonic perforations in a porcine colon model.

BACKGROUND AND STUDY AIM Colonic perforation is a serious complication of colonoscopy, with surgical repair usually indicated. The aim was to compare acute strength of various endoscopic colonic closure techniques by assessing air leak pressures in a previously described ex vivo experimental apparatus. METHODS Standardized colonic perforations were created using fresh porcine colon and subsequently closed on a bench. Six techniques included surgical suture (gold standard), QuickClips, T-tags, over-the-scope-clip (OTSC) system, and two types of flexible stapler (Covidien). After closure, each specimen was fixed in the apparatus and pressure was gradually increased until air bubbles were seen. Leak pressure was the primary outcome parameter. Closure using the gold standard (first 15 experiments) resulted in a mean leak pressure of 86.9 mmHg (SD 7). Using a noninferiority design a sample size of 12 specimens for each closure technique was determined. RESULTS Mean colotomy leak pressures in millimeters of mercury (mmHg) and difference (with 95% confidence intervals [CI]) between each technique and the gold standard were: QuickClips 85.1 (difference -1.8; 95% CI -7.0 to 3.9); T-tags 53.9 (difference -33.0; -39.0 to -27.0); OTSC 90.3 mmHg (difference 3.4; -6.1 to 12.9); 15-mm shaft stapler 98.5 mmHg (difference 9.7; 0.8 to 18.5) and 8-mm shaft stapler 96.6 mmHg (difference 11.6; 1.5 to 21.7). CONCLUSIONS OTSCs, QuickClips, and both flexible staplers produced results comparable to hand-sewn colotomy closure in this ex vivo porcine colonic model. These devices seem to be prime candidates for further evaluation in survival animal studies.

Feasibility of transgastric and transcolonic natural orifice transluminal endoscopic surgery peritoneoscopy combined with intraperitoneal EUS

BACKGROUND If natural orifice transluminal endoscopic surgery (NOTES) peritoneoscopy is to become an alternative to diagnostic laparoscopy, NOTES peritoneoscopy must be comparable to laparoscopy in its diagnostic accuracy. OBJECTIVE To assess the feasibility of transgastric (TG) and transcolonic (TC) NOTES peritoneoscopy combined with intraperitoneal EUS. DESIGN Twelve nonsurvival experiments on 6 female pigs. SETTING Animal laboratory. PATIENTS Six 35- to 40-kg female pigs. INTERVENTIONS Randomization was performed to determine the order of approach (TG or TC as first procedure). After peritoneal access, systematic peritoneoscopy was performed according to a preassessed list of 12 locations considered clinically important. For each visualized location, 1 point was scored and 1 point added if it was touched as well, leading to a maximum score of 24 points. Subsequently, the endoscope was exchanged for a linear EUS-scope. The percentage of visualization of the 4 sections of the liver was recorded (0, not visible; 1, 33%; 2, 66%; 3, 100%; maximum score, 12 points). After withdrawal, the protocol was repeated by using the second natural orifice (TG or TC). MAIN OUTCOME MEASUREMENTS Extent of adequate visualization of diagnostic peritoneoscopy and intraperitoneal EUS measured by a preassessed record form. RESULTS Access was achieved without difficulties at all 12 sites. TG peritoneoscopy resulted in a median of 23 points (range 20-24) via the TC approach. A maximum of 24 points was recorded in all pigs (P = .102). TG-EUS resulted in a median of 11 points (range 6-12) and TC-EUS in a median of 12 points (range 8-12) (P = .317). LIMITATION Lack of objective landmarks for EUS. CONCLUSIONS TG and TC NOTES peritoneoscopy combined with intraperitoneal EUS is technically feasible. Furthermore, NOTES peritoneoscopy and intraperitoneal EUS seem to result in adequate visualization of the peritoneal cavity and liver, respectively.

Comparison of transgastric NOTES and laparoscopic peritoneoscopy for detection of peritoneal metastases

Background:Transgastric peritoneoscopy (TGP) may be a future alternative to the diagnostic laparoscopy (LAP). Objective:To create a model of peritoneal metastases for development of TGP and to employ this model to compare TGP to LAP. Methods:Small beads were stapled in porcine peritoneal cavities to simulate metastases. Using a noninferiority design a sample size of 64 beads was determined, which were divided over 12 animals. Randomization was performed for number and location of beads. LAP was performed by one of 2 blinded surgeons. TGP was then performed in the same pig using either standard endoscopic accessories (TGP-s) or a specially designed toolkit (TGP-t) in randomized order by 1 of 2 blinded endoscopists. Primary outcome was number of beads found and touched during peritoneoscopy. Results:Locations of beads included: abdominal peritoneum (14 beads), diaphragm (11), surface of liver and hepatoduodenal ligament (32), and miscellaneous sites (7). LAP detected 61 beads (yield = 95%), TGP-s 40 beads (63%), and TGP-t 40 beads (63%). TGP-s and TGP-t were both inferior in comparison with LAP (P = 0.8465 and P = 0.7440 respectively). TGP-s and TGP-t were similar in number, distribution and time to detect beads. TGP was superior for detecting beads on the abdominal and diaphragmatic peritoneum than for the liver, namely TGP-s: 23/25 (92%) versus 12/32 (38%) (P < 0.001); TGP-t: 25/25 (100%) versus 11/32 (34%) (P < 0.001). Conclusion:In this first prospective, blinded, comparative trial TGP was inferior to LAP for the detection of simulated metastases. Future development for NOTES peritoneoscopy should focus on improved access to the region of the liver and enhanced endoscopic optics and performance.

Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial

BACKGROUND Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN09186711. FINDINGS Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0·97, 95% CI 0·62-1·51; p=0·88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1·38, 95% CI 0·53-3·59, p=0·50), nor did any of the major complications included in the primary endpoint. INTERPRETATION In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference. FUNDING The Dutch Digestive Disease Foundation, Fonds NutsOhra, and the Netherlands Organization for Health Research and Development.

Laparoscopic resection with transcolonic specimen extraction for ileocaecal Crohn's disease.

Ileocolic resection for Crohns disease can be performed entirely laparoscopically. However, an incision is needed for specimen extraction. This prospective observational study assessed the feasibility of endoscopic transcolonic specimen removal.