Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.

BACKGROUND: Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined. METHODS: This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy. The trial focused on procedure development, reproducibility, safety, and short-term efficacy. The trial was performed at centers in five countries, in three phases. Phase I was evaluation of safety and technical feasibility of various procedure techniques; stitch patterns and sequences were assessed for efficiency, safety, and feasibility. Phase II entailed continued procedure refinement to establish a standardized technique. Phase III entailed evaluation of technical feasibility and weight loss outcomes in 77 patients; the procedure was performed using the standardized technique, and there was no procedure development. Data were prospectively collected into a registry. RESULTS: In Phase I, the procedure was created and modified to improve time efficiency. Safety and technical feasibility were established, and short-term weight loss was demonstrated. In Phase II, a number of stitch patterns were attempted, and the stitch pattern was modified and finalized. 22 patients were included, and 1-year total weight loss was 17.3 ± 2.6%. In Phase III, conformity with the final technique was high. 77 patients were included, with a mean BMI of 36.1 ± 0.6 kg/m2. Mean weight loss was 16.0 ± 0.8% at 6 months and 17.4 ± 1.2% at 12 months (n = 44). Postprocedural nausea, vomiting, and epigastric pain were frequently reported; there were no reported significant adverse events post-procedure or during the follow-up period. CONCLUSIONS: Following a methodical procedure development phase, ESG demonstrated safety and short-term efficacy in this trial. The procedure also achieved meaningful weight loss during the follow-up period.

Pancreaticoureteral Fistula: A Rare Complication of Chronic Pancreatitis.

CONTEXT: Chronic pancreatitis is an inflammatory condition that may result in progressive parenchymal damage and fibrosis which can ultimately lead to destruction of pancreatic tissue. Fistulas to the pleura, peritoneum, pericardium, and peripancreatic organs may form as a complications of pancreatitis. This case report describes an exceedingly rare complication, pancreaticoureteral fistula (PUF). Only two additional cases of PUF have been reported. However, they evolved following traumatic injury to the ureter or pancreatic duct. No published reports describe PUF as a complication of pancreatitis. CASE REPORT: A 69-year-old Hispanic female with a past medical history of cholecystectomy, pancreatic pseudocyst, and recurrent episodes of pancreatitis presented with severe, sharp, and constant abdominal pain. Upon imaging, a fistulous tract was visualized between the left renal pelvis (at the level of an upper pole calyx) and the pancreatic duct and a ureteral stent was placed to facilitate fistula closure. Following the procedure, the patient attained symptomatic relief and oral intake was resumed. A left retrograde pyelogram was repeated 2 months after the initial stent placement and demonstrating no evidence of a persistent fistulous tract. CONCLUSION: Due to PUF's unclear etiology and possible variance of presentation, it is important for physicians to keep this rare complication of pancreatitis in mind, especially, when evaluating a patient with recurrent pancreatitis, urinary symptoms and abnormal imaging within the urinary collecting system and pancreas.

An unusual initial presentation of hepatocellular carcinoma as a sellar mass.

Sellar masses are frequently adenomatous pituitary tumors. Metastatic disease is unusual, often mimicking the presentations of adenomas. Hepatocellular carcinoma (HCC) is the most common primary hepatic malignancy but unusual to have a pituitary metastasis (PM). A 65-year-old man presented with headache, diplopia, ptosis, decreased vision in the right eye and unintentional weight loss of 32lbs. Preliminary out-patient work-up revealed a mass in the pituitary region. Cranial imaging showed 3.1 cm × 3.2 cm × 4.4 cm lesion. Abdominal imaging (computed tomography and magnetic resonance imaging) demonstrated a lobulated, nodular and heterogeneous right lobe of the liver. Trans-sphenoidal resection of the sellar mass favored metastatic HCC on histology. Liver biopsy confirmed HCC. We recommend maintaining an increased clinical suspicion upon evaluation of nonclassical clinical and radiological presentations of suspected PM/malignancy; as well as pursuing additional investigations in all early cases.

Magnetic pancreaticobiliary stents and retrieval system: obviating the need for repeat endoscopy (with video).

BACKGROUND: Plastic stents are routinely placed in the pancreaticobiliary system to facilitate drainage. A second endoscopy is often required for stent removal. We have developed magnetic pancreaticobiliary stents that can be removed by using an external hand-held magnet, thereby obviating the need for a second endoscopy. OBJECTIVE: To develop and test magnetic pancreaticobiliary stents and retrieval system in ex-vivo and in-vivo porcine models. SETTING: Animal laboratory. DESIGN: Benchtop and animal study. ANIMALS: 5 pigs. INTERVENTIONS: Design: Computer simulations determined both the optimal design of cylindrical magnets attached to the distal aspect of existing plastic stents and the optimal design of the external hand-held magnet. Benchtop ex-vivo experiments measured magnetic force to validate the design. In-vivo analysis: In 5 Yorkshire pigs, magnetic stents were deployed into the common bile duct by using a conventional duodenoscope. An external hand-held magnet was applied for stent removal. Stent insertion and removal times were recorded. MAIN OUTCOME MEASUREMENTS: Technical feasibility. RESULTS: Magnetic stents of varying lengths and calibers were successfully created. In ex-vivo testing, the capture distance was 10.0 cm. During in-vivo testing, the magnetic stents were inserted and removed easily. The mean insertion and removal times were 3.2 minutes and 33 seconds, respectively. LIMITATIONS: Animal study, small numbers. CONCLUSIONS: Magnetic pancreaticobiliary stents and associated retrieval system were successfully designed and tested in the acute porcine model. An external, noninvasive means of stent removal potentially obviates the need for a second endoscopy, which could represent a major gain both for patients and in health care savings.

An implantable wireless biosensor for the immediate detection of upper GI bleeding: a new fluorescein-based tool for diagnosis and surveillance (with video).

BACKGROUND: Early recurrent hemorrhage after endoscopic intervention for acute upper GI bleeding (UGIB) can approach 20% and leads to increased morbidity and mortality. Little has changed over the past several decades regarding immediate posthemorrhage surveillance, and there has likewise been no significant improvement in outcomes. OBJECTIVE: To develop and test an endoscopically implantable wireless biosensor for real-time detection of fluorescein-labeled blood in ex vivo and in vivo porcine models of UGIB. SETTING: Animal laboratory. DESIGN: Benchtop and acute animal studies. SUBJECTS: Five pigs. INTERVENTIONS: UGIB models were surgically created in living pigs. Biosensors were endoscopically deployed in the stomach using standard endoscopic clips. The ability to detect acute UGIB and estimated blood loss leading to biosensor activation were recorded. Feasibility of wireless data transmission out of the body to an external computer and cell phone was assessed. MAIN OUTCOME MEASUREMENTS: Technical feasibility and immediate complications. RESULTS: A porcine UGIB model was successfully created. Biosensors were able to detect all acute bleeding events and wirelessly transmit out of the body, and successfully sent an emergency text message to the intended cell phone in all cases. Average estimated blood loss leading to biosensor activation was 30 mL (10-75 mL). LIMITATIONS: Animal study; small numbers. CONCLUSIONS: An endoscopically implantable wireless biosensor successfully detected acute hemorrhage in a porcine UGIB model and sent an emergency cell-phone alert in real time.

Smart Self-Assembling MagnetS for ENdoscopy (SAMSEN) for transoral endoscopic creation of immediate gastrojejunostomy (with video).

BACKGROUND: Gastrojejunostomy is important for palliation of malignant gastric outlet obstruction and surgical obesity procedures. A less-invasive endoscopic technique for gastrojejunostomy creation is conceptually attractive. Our group has developed a compression anastomosis technology based on endoscopically delivered self-assembling magnets for endoscopy (SAMSEN) to create an instant, large-caliber gastrojejunostomy. OBJECTIVE: To develop and evaluate an endoscopic means of gastrojejunostomy creation by using SAMSEN. SETTING: Developmental laboratory and animal facility. DESIGN: Animal study and human cadaveric study. SUBJECTS: Yorkshire pigs (7 cadaver, 5 acute); human (1 cadaver). INTERVENTIONS: A transoral procedure for SAMSEN delivery was developed in porcine and human cadaver models. Subsequently, gastrojejunostomy creation by using SAMSEN was performed in 5 acute pigs. The endoscope was advanced into the peritoneal cavity through the gastrotomy, and a segment of the small bowel was grasped and pulled closer to the stomach. An enterotomy was created, and a custom overtube was advanced into the small bowel for deployment of the first magnetic assembly. Next, a reciprocal magnetic assembly was deployed in the stomach. The 2 magnetic systems were mated under fluoroscopic and endoscopic guidance. Contrast studies assessed for gastrojejunostomy leak. Immediate necropsies were performed. MAIN OUTCOME MEASUREMENTS: Technical feasibility and complications. RESULTS: Gastrojejunostomy creation by using SAMSEN was successful in all 5 animals. Deep enteroscopy was performed through the stoma without difficulty. No leaks were identified on contrast evaluation. At necropsy, the magnets were properly deployed and robustly coupled together, resistant to vigorous tissue manipulation. LIMITATIONS: Acute animal study. CONCLUSIONS: Endoscopic creation of immediate gastrojejunostomy by using SAMSEN is technically feasible.

Natural orifice translumenal surgery: Flexible platform review.

Natural orifice translumenal surgery (NOTES) has garnished significant attention from surgeons and gastroenterologists, due to the fusion of flexible endoscopy and operative technique. Preliminary efforts suggest that NOTES holds potential for a less invasive approach with certain surgical conditions. Many of the hurdles encountered during the shift from open to laparoscopic surgery are now being revisited in the development of NOTES. Physician directed efforts, coupled with industry support, have brought about several NOTES specific devices and platforms to help address limitations with current instrumentation. This review addresses current flexible platforms and their attributes, advantages, disadvantages and limitations.

A magnetic retrieval system for stents in the pancreaticobiliary tree.

Clinical endoscopic intervention of the pancreaticobiliary tree [endoscopic retrograde cholangiopancreatography (ERCP)] often concludes with the insertion of a temporary plastic stent to reduce the risk of post-ERCP complications by promoting continued flow of bile and pancreatic fluids. This stent is later removed once the patient has fully recovered, but today this necessitates a second endoscopic intervention. The final goal of this work is to obviate the second intervention. This is to be achieved by adding a magnetic ring to the stent such that the stent is removed using a hand-held magnet, held in a suitable position ex vivo . This paper details the design, optimization, and both ex vivo and in vivo testing of the magnetized stent and hand-held magnet, which has been accomplished to date. The optimized design for the hand-held magnet and the modified stent with a magnetic attachment performs in line with simulated expectations, and successful retrieval is achieved in the porcine ex vivo setting at 9-10 cm separation. This is comparable to the mean target capture distance of 10 cm between the entry point to the biliary system and the closest cutaneous surface, determined from random review of clinical fluoroscopies in ten human patients. Subsequently, the system was successfully tested in vivo in the acute porcine model, where retrieval at an estimated separation of 5-6 cm was captured on endoscopic video. These initial results indicate that the system may represent a promising approach for the elimination of a second endoscopic procedures following placement of pancreatic and biliary stents.

Early healing of transcolonic and transgastric natural orifice transluminal endoscopic surgery access sites.

BACKGROUND: Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a developing, minimally invasive surgical approach whose potential benefits are being investigated. Little is known about secure access site closure and early healing kinetics of transvisceral access. STUDY DESIGN: Transvisceral access incisions were created in the colon (C-NOTES, n = 8) and stomach (G-NOTES, n = 8) for peritoneal exploration. Incisions were closed primarily with endoloops, endoclips, or t-tags. Macroscopic and histologic analyses performed on postoperative day 7 assessed gross appearance, granulation tissue, inflammation, ulceration, and complications. RESULTS: Macroscopically, incisions appeared closed without intraperitoneal spillage. Incisions closed by endoloop and t-tags showed intense granulation tissue fill of defect despite partial (G-NOTES, n = 3) and transmural ulceration (C-NOTES, n = 8; G-NOTES, n = 3). Of the 30 t-tags applied, 40% broke or deployed into the peritoneal cavity. Endoclip closures (C-NOTES, n = 1; G-NOTES, n = 1) did not show histologic mucosal continuity. Healing complications included transmural necrosis (C-NOTES, n = 1; G-NOTES, n = 1), foreign body material (C-NOTES, n = 3; G-NOTES, n = 2), and microabscesses (G-NOTES, n = 1). CONCLUSIONS: This study provides a reproducible model to assess noninvasive repair of planned visceral perforations. Of investigated technologies, endoloop closure was favored for transcolonic incisions, and t-tags with omental patch for transgastric incisions, although these have significant limitations. Endoclips were inadequate for primary closure, but may be useful as an adjunctive closure modality. Additional studies are needed to examine visceral repair at later time points, as they will help determine the quality and kinetics of repair of a variety of incision closure strategies. This study demonstrates the need for improved technologies to more reliably close visceral transluminal defects.

Efficacy of a reverse-phase polymer as a submucosal injection solution for EMR: a comparative study (with video).

INTRODUCTION: Reverse-phase polymers undergo a temperature-dependent liquid-to-gel transition that may provide a more durable cushion for EMR and could yield improvements in safety and efficacy. OBJECTIVE: Our purpose was to assess the efficacy of poloxamer solution PS137-25 as a submucosal injection. DESIGN: Comparative study among 3 different solutions for EMR using ex vivo and in vivo porcine models. INTERVENTIONS: A total of 120 gastric submucosal cushions were performed in fresh ex vivo porcine stomachs with saline solution 0.9% (n = 40), hydroxypropyl methylcellulose (HPMC) (n = 40), and PS137-25 (n = 40). Five in vivo porcine colon EMRs were then performed. MAIN OUTCOME MEASUREMENTS: Height and duration of submucosal cushions were measured in the ex vivo model, and the usefulness of reverse-phase polymers was assessed by in vivo en bloc resection. RESULTS: Ex vivo: The height of mucosal elevation was greater with PS137-25 (10.3 +/- 2.2 mm) than with saline solution (8.3 +/- 2.6 mm) or HPMC (9.05 +/- 2.3 mm, not significant). All submucosal elevations with PS137-25 lasted longer (more than 20 minutes) than with saline solution (20.9 +/- 11 minutes, P < .01) or HPMC (89 +/- 32 minutes, P < .01). After 120 minutes, the elevations obtained with PS137-25 showed no differences in size, shape, or consistency from initial measurements. In vivo: All 5 EMRs were successfully performed after 1 injection of PS137-25. No repeat injections were needed. During resection, a large gel cushion was noted. CONCLUSIONS: Mucosal elevation with PS137-25 is more durable than with other substances, with no changes in size or consistency observed over 120 minutes. Additionally, reverse-phase polymers performed well in in vivo colon EMRs. These results suggest that reverse-phase polymers may provide increased safety and efficacy for EMR procedures.

Impact of patient education on quality of bowel preparation in outpatient colonoscopies.

BACKGROUND: High-quality bowel preparation is essential for successful outpatient colonoscopy. Currently, the rate of adequate bowel preparation for outpatient colonoscopy in the USA is low. Patients often fail to adhere to recommended preparation instructions. Limited literature exists on evaluating educational intervention as a means of improving the quality of bowel preparation prior to outpatient colonoscopy. OBJECTIVE: Our objective was to determine the effect of an educational intervention on the quality of outpatient colonoscopy preparation. The secondary objective was to determine whether the quality of bowel preparation improves overall colonoscopy outcomes as measured by rate of polyp detection and caecal intubation time. METHODS: A single-blinded, prospective, randomised, controlled trial was conducted in two inner-city gastroenterology clinics in the USA. One hundred and sixty-four subjects were enrolled and randomly assigned to one of two groups. The control group subjects received verbal and written instructions for colonoscopy. The intervention group subjects received the same instructions and were then asked to answer a questionnaire. The subjects' responses were reviewed and an additional explanation of the preparation process provided. An attending gastroenterologist determined the quality of each bowel preparation at the time of colonoscopy using the Universal Preparation Assessment Scale. RESULTS: The educational intervention had no impact on the overall quality of bowel preparation (P=0.12). However, the type of food (liquid vs solid) consumed during the 24 hours prior to the procedure (P=0.04) and the time since the last solid meal (P=0.03) did have an impact on preparation quality. Other significant factors included elapsed time to first bowel movement from the initiation of bowel preparation (P=0.05) and age younger than 55 (P=0.02). Adequate bowel preparation was associated with shorter total procedure (P=0.001) and caecal intubation (P=0.01) times. CONCLUSION: Our study failed to demonstrate any effect of an educational intervention on the quality of colonoscopy preparation. However, adherence to simple dietary instructions did have a significant impact on the quality of bowel preparation. Adequate bowel preparation was associated with shorter procedure time and caecal intubation time.