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Enteryx (R): Worldwide pivotal studies in 237 patients [Meeting Abstract]
Cohen, LB; Aisenberg, J; Foley, TR; Ganz, RA; Johnson, DA; Lehman, GA; Schumacher, B; Neuhaus, H; Ortner, M; Laugier, R; Ponchon, T; Peters, JH; Haber, GB; Deviere, J
ISI:000224479700891
ISSN: 0002-9270
CID: 1861662
A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study
Chuttani, Ram; Sud, Randhir; Sachdev, Gopal; Puri, Rajesh; Kozarek, Richard; Haber, Gregory; Pleskow, Douglas; Zaman, Mohammed; Lembo, Anthony
BACKGROUND: The novel full-thickness plication described in this study was designed to inhibit gastroesophageal reflux by placement of a transmural plication near the gastroesophageal junction under direct endoscopic visualization. The resulting serosa-to-serosa tissue union is thought to accentuate and restore the valvular mechanism of the gastroesophageal junction. The aim of this study was to assess the safety and feasibility of endoscopic full-thickness plication for the treatment of patients with GERD symptoms. METHODS: A pilot study was performed in patients with chronic heartburn and pathologic reflux requiring maintenance antisecretory therapy. A single full-thickness plication was placed in the gastric cardia within 1 to 2 cm of the gastroesophageal junction. The primary end points of the study were procedure safety and feasibility, as well as long-term durability of the full-thickness tissue fixation. Secondary end points included medication use and the GERD-Health Related Quality of Life questionnaire and Gastrointestinal Symptom Rating Scale. RESULTS: Full-thickness plication was performed successfully in 6 of 7 patients, with one procedure aborted because of difficulty in sedating the patient. Mean procedure time was 21 minutes. Mild epigastric pain was reported by two patients and difficulty with eructation by one patient; all symptoms resolved spontaneously within 7 days of the procedure. Endoscopy at 6 months revealed an intact plication in all patients. At 1 year after the procedure, patients reported sustained reduction in heartburn scores. One patient, who did not experience significant relief of symptoms, ultimately underwent successful laparoscopic Nissen fundoplication at 6 months after the procedure. At 1 year after the procedure, 3 of 5 patients were not taking anti-GERD medications. CONCLUSIONS: Endoscopic full-thickness plication is feasible, safe and, in this pilot study, appeared to reduce symptoms and medication use associated with GERD.
PMID: 14595322
ISSN: 0016-5107
CID: 1860382
Ampullary adenoma: clinical manifestations, diagnosis, and treatment
Martin, John A; Haber, Gregory B
Ampullary adenomas occur sporadically and in the setting of familial polyposis syndromes. In either case, and whether symptomatic at presentation or found asymptomatically in the setting of endoscopic screening programs, they are premalignant lesions with risk for malignant degeneration to carcinoma following the adenoma-to-carcinoma sequence that is well recognized in colonic adenocarcinoma. Accordingly, many experts advocate excision, although others cite the low rate of histologic progression suggested by some recent studies as justification for close endoscopic surveillance rather than excision before demonstration of dysplastic change. This recommendation, however, is complicated by considerable data underscoring the limited accuracy of endoscopic forceps biopsy in detecting occult foci of carcinoma within ampullary adenoma. Thus, the optimal management of these lesions continues to generate considerable controversy. Indications for excision of an ampullary adenoma include treatment of immediate symptoms as well as prevention of malignant degeneration. Although pancreaticoduodenectomy has long been considered the standard procedure for ampullary carcinoma, much controversy exists regarding the procedure of choice for ampullary adenoma. Radical surgery (pancreaticoduodenectomy) possesses the advantage of low recurrence rate but at the expense of higher morbidity (25%-65%) and mortality (0%-10%). Local surgical excision (surgical ampullectomy) possesses the advantages of lower morbidity (0%-25%), essentially nil mortality, and possibly decreased length of hospital stay, but decidedly higher recurrence rates (generally 5%-30%) and the need for postoperative endoscopic surveillance. Snare ampullectomy is a newer endoscopic excisional technique for which limited data are available; advantages compared with radical surgery mirror those of local surgical excision, with apparent lower mortality (0%-1%) and lower morbidity (12%). Presumed advantages compared with local surgical excision include lack of necessity for general anesthesia and laparotomy with comparable morbidity. Disadvantages seem to include limited availability of experienced operators, procedural complexity sometimes requiring adjunctive modalities such as fulguration, the need for multiple procedures (mean, 2.0 procedures) to effect complete excision, and recurrence rates approaching 30%, with a requirement for continued endoscopic surveillance. Ultimately, choice is driven by availability of local expertise, patient tolerance of or expected compliance with long-term endoscopic surveillance programs, presence or absence of coexisting familial polyposis syndromes, medical comorbidities, and overall life expectancy.
PMID: 14986792
ISSN: 1052-5157
CID: 1860362
Capsule endoscopy regional transit abnormality: a sign of underlying small bowel pathology [Case Report]
Tang, Shou-Jiang; Zanati, Simon; Dubcenco, Elena; Christodoulou, Dimitrios; Cirocco, Maria; Kandel, Gabor; Kortan, Paul; Haber, Gregory B; Marcon, Norman E
BACKGROUND: Wireless capsule endoscopy is being used increasingly to investigate GI bleeding of obscure etiology and other small bowel abnormalities. Currently, there is no standard for capsule endoscopy image interpretation and classification METHODS: This report describes an abnormality, termed "regional transit abnormality," noted during a review of capsule endoscopic images. Capsule regional transit abnormality simply refers to delayed capsule transit within a segment of small bowel, with or without visualization of a mucosal abnormality. The slowed transit usually is accompanied by mucosal collapse, sometimes with the appearance of the capsule pressing or impacting upon the mucosa. Regional transit abnormality usually persists more than 15 minutes CONCLUSIONS: Capsule regional transit abnormality is considered to be a "red flag" sign that indicates a likelihood of some underlying small bowel pathology.
PMID: 14520302
ISSN: 0016-5107
CID: 1860392
In vivo Doppler optical coherence tomography of mucocutaneous telangiectases in hereditary hemorrhagic telangiectasia
Tang, Shou-Jiang; Gordon, Maggie L; Yang, Victor X D; Faughnan, Marie E; Cirocco, Maria; Qi, Bing; Yue, Emily Seng; Gardiner, Geoffrey; Haber, Gregory B; Kandel, Gabor; Kortan, Paul; Vitkin, Alex; Wilson, Brian C; Marcon, Norman E
BACKGROUND: Hereditary hemorrhagic telangiectasia is characterized by mucocutaneous telangiectases and visceral arteriovenous malformations. Knowledge is limited concerning the development hemodynamics of mucocutaneous telangiectases. Doppler optical coherence tomography can demonstrate microvascular blood flow at flow rates as low as 20 microm/second, which is up to approximately 100 times more sensitive than Doppler US. The aims of this study were to collect in vivo Doppler optical coherence tomography images of mucocutaneous telangiectases and normal surrounding mucosa and skin, and to gain experience for an in vivo GI endoscopic study. It was hypothesized that visibly normal areas may have occult telangiectases and that mucocutaneous telangiectases that have bled may have a higher rate of blood flow than mucocutaneous telangiectases with no history of bleeding. METHODS: Twelve patients with hereditary hemorrhagic telangiectasia and mucocutaneous telangiectases were studied. Two to 3 visible mucocutaneous telangiectases on the digits, lips, and tongue were imaged with Doppler optical coherence tomography, along with visually normal surrounding areas at each site. The Doppler optical coherence tomography images were obtained in 0.5 second by using 1310 nm light. RESULTS: A total of 67 mucocutaneous telangiectases from the 12 patients were imaged (38 digit, 16 lip, 13 tongue). Blood flow was demonstrated within every mucocutaneous telangiectasis imaged. Doppler optical coherence tomography did not identify any abnormal vasculature within visually normal areas. Mucocutaneous telangiectases with a history of bleeding (n = 18) were situated closer to the surface, compared with mucocutaneous telangiectases with no bleeding history (n = 49), but there was no difference in the Doppler flow appearance. CONCLUSIONS: Visually normal areas in patients with hereditary hemorrhagic telangiectasia did not appear to have abnormal vasculature. Mucocutaneous telangiectases with a history of bleeding were more superficial but were otherwise similar to mucocutaneous telangiectases with no bleeding history.
PMID: 14520301
ISSN: 0016-5107
CID: 1860402
Endoscopic implantation of enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial
Johnson, David A; Ganz, Robert; Aisenberg, James; Cohen, Lawrence B; Deviere, Jacques; Foley, T Raymond; Haber, Gregory B; Peters, Jeffrey H; Lehman, Glen A
OBJECTIVES: This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD). METHODS: In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2-4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by >/=50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events. RESULTS: At 12 months, 80.3% (95% CI = 69.9%-88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by >/=50%. Treatment response was more likely in patients with residual implant volume of >/=5 mL (p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline (p < 0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH <4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication. CONCLUSIONS: Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.
PMID: 14499767
ISSN: 0002-9270
CID: 1860412
Endoscopic full-thickness plication for GERD: 12-Month multi-center study results [Meeting Abstract]
Pleskow, Douglas K; Rothstein, Richard I; Lo, Simon K; Hawes, Robert H; Kozarek, Richard A; Haber, Gregory B; Gostout, Christopher J; Lembo, Anthony J
BCI:BCI200400048575
ISSN: 0002-9270
CID: 1861832
Is seeing believing? [Comment]
Haber, Gregory B
PMID: 12709701
ISSN: 0016-5107
CID: 1860422
Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial
Johnson, David A; Ganz, Robert; Aisenberg, James; Cohen, Lawrence B; Deviere, Jacques; Foley, T Raymond; Haber, Gregory B; Peters, Jeffrey H; Lehman, Glen A
OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.
PMID: 12591037
ISSN: 0002-9270
CID: 1860432
"The devil is in the details". Reflections on an "overview" of endoscopic treatment of post liver transplant bile duct strictures [Comment]
Haber, G B
PMID: 12502208
ISSN: 1590-8658
CID: 1860472