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A novel endoscopic full thickness plicator for the treatment of GERD: Feasibility study and comparison of ease of use in cadaveric human and pig stomachs
*3423 PRIMARY EXPLORATORY LAPAROSCOPY IN YOUNGER PATIENTS WITH OBSCURE GASTROINTESTINAL BLEEDING: A PROSPECTIVE EVALUATION Blair S. Lewis, Anthony R. De Lillo, Peter E. Legnani, Mark A. Reiner, Robert A. Aldoroty, Bernhard Sauter, Mount Sinai Medical Ctr, New York, NY Background: Patients with obscure GI bleeding are often thought to have small bowel angiodysplasia as the cause of their bleeding. However, otherwise healthy patients under the age of 50 most often have a small bowel tumor as the cause of bleeding. Exploratory laparotomy has long been suggested in younger patients with obscure bleeding, though diagnostic yields have never been reported and patients are usually unwilling to undergo exploratory surgery. We report on the prospective use of primary exploratory laparoscopy in patients with obscure bleeding. Methods: Since 1993, all otherwise healthy patients under the age of 60 who were referred for evaluation of obscure GI bleeding were referred for primary exploratory laparoscopy. Patients were excluded if they had a history of renal insufficeney, cirrhosis, valvular heart disease, or hereditary hemorrhagic telangiectasia syndrome. At laparoscopy, the small bowel was run from the ligament of Trietz to the ileocecal valve using partially open grasping forceps. Ira lesion was found, it was resected at that time. The small bowel was run three times before it was concluded that no site was found in a negative exam. Followup was obtained by direct phone calls to patients. Results: 32 patients were referred for primary exploratory laparoscopy between August 1993 and July 2000. There were 26 men and 6 women. The average age was 39 (19-60). All patients had a history of obscure bleeding and had an extensive evaluation previously including at least one colonoscopy and one upper endoscopy. 25 had had normal enteroscopic examinations. Four patients declined surgery. Followup data on one patient was unavailable. Of 27 patients who underwent exploratory laparoscopy, 17 (63%) had a source of bleeding identified and underwent simultaneous small bowel resection. Diagnoses made included leiomyoma (4), carcinoid (3), lymphoma (2), Meckers (2), lymphangiectasia (1), leiomyosarcoma (1), melanoma (1), Crohn's ileitis (1), endometrioma (1), adenocarcinoma (1). Ten patients (37%) had no source of bleeding found at laparoscopy. 4 have had no further bleeding, 3 were lost to followup, 2 were found to have small intestinal angiodysplasias at subsequent laparotomy and intraoperative endoscopy, and 1 was treated for hemorrhoids. Conclusions: Primary exploratory laparoscopy is an efficient and effective means of evaluating patients under the age of 60 with obscure GI bleeding and should be considered a standard part of the workup of such patients.
*3424 A NOVEL ENDOSCOPIC FULL THICKNESS PLICATOR FOR THE TREATMENT OF GERD: FEASIBILITY STUDY AND COMPARISON OF EASE OF USE IN CADAVERIC HUMAN AND PIG STOMACHS. Ram Chuttani, Beth Israel Deaconess Medical Ctr, Boston, M.A; Gopal Sachdev, Maulana Azad Medical Coll, New Delhi India; Randhir Sud, Sir Ganga Ram Hosp, New Delhi India; Steven L. Brandwein, Douglas K. Pleskow, Subhas Banerjee, Jonathan Critchlow, Beth Israel Deaconess Medical Ctr, Boston, MA Aim: To assess the feasibility of performing endoscopic full thickness plication using a new endoscopic plication device for GERD and to compare the relative ease of use of the device in cadaveric human and pig stomachs. Methods: A new endoscopic full thickness plication device (NDO Surgical Inc., Mansfield, MA) plicates the wall of the stomach and fixates it with a single pre-tied suture based implant. The device was used to create plications in cadeveric human and pig stomachs. Stomach wall thickness was determined in 5 live patients by EUS. The new plication device was used to perform full thickness tissue plications in a formalin preserved human stomach, 2 fresh cadaveric stomachs, a freshly resected human stomach and 8 pig stomachs. The ease of performing plicatians at different sites near the GE junction was assessed. The stomachs were then dissected to
ABll4
GASTROINTESTINAL ENDOSCOPY
assess the presence of full thickness intraluminal plication bulges, the presence of which denotes a successful result. Results: An average of 2 plications each were performed in 8 pig stomachs, the formalin preserved human stomach and the 2 cadeveric human stomachs. All plications were full thickness resulting in serosa to serosa apposition and satisfactory intraluminal tissue bulges. It was significantly easier to accurately position the plication device and perform plication in cadavaric human stomachs than in pig stomachs, due to anatomical differences. EUS in the 5 live patients determined wall thickness near the GE junction to be between 2.8 and 4.1 mm. The cadaveric human specimens had significantly thinner walls when compared to live human and pig stomachs, possibly due to autolysis. The plication device was subsequently used satisfactorily in the freshly resected human stomach. Conclusions: 1. Full thickness endoscopic plication of the stomach wall near the GE junction using the new endoscopic plication device is feasible in the human stomach. 2. The cadeveric human stomach wall is significantly thinner than the pig stomach, but this does not affect the ability of the device to create satisfactory intraluminal tissue bulges. 3. The positioning of the device and plication are significantly easier to perform in the cadaveric human stomach compared to pig stomachs.
*3425 CRITERIA FOR THE DIAGNOSIS OF DYSPLASIA BY OPTICAL COHERENCE TOMOGRAPHY (OCT) Patrick R. Pfau, Michael V. Sivak Jr, Margaret Kinnard, Univ Hospitals of Cleveland, Cleveland, OH; Joseph Izatt, Andrew M. Rollins, Case Western Reserve Univ, Cleveland, OH; Richard Ck Wang, Univ Hospitals of Cleveland, Cleveland, OH; Volker Westphal, Case Western Reserve Univ, Cleveland, OH; Gerard A. Isenberg, Univ Hospitals of Cleveland, Cleveland, OH AIM: We hypothesized, based on observations in Barrett's esophagus, that dysplastic tissue has characteristic OCT image features that include loss of architectural (histologic) organization and decreased refleetivity. OCT imaging is based on light scattering by tissue. Dysplastic tissue may scatter light differently than normal tissue. To test this hypothesis we used colon polyps as a model of dysplasia and prospectively assessed the ability to differentiate adenoma from non-adenoma by OCT METHODS: OCT images were obtained of polyps in patients undergoing colonoscopy using a circular scanning OCT probe (2 mm focus). Phase I: In real time, endoscopists rated the degree to which OCT images of polyps and normal mucosa exhibited histologic structure (primarily the presence of crypts) on a scale of 0 (none) to 5 (most organized). Reflectivity was rated on a scale of 0 (none) to 5 (highest). Tissue organization and reflectance were compared for adenomas, hyperplastic polyps and normal mucosa (chi-squared analysis). Phase II: Pairs of images were captured digitally for polyps and normal mucosa. A software generated square (60 x 60 pixels) was placed over the digital images and the degree of reflectance within the square computed. Complete reflectance assigned a value of 100, no reflectance a value of 0. Differences between polyps and normal mucosa were assessed by histologic type (Student's t-test). RESULTS: 35 polyps (21 patients; llF, 10 M; mean age 67.2 yrs) were imaged with OCT, removed and classified histologically (adenoma 24, hyperplastic 8, normal mucosa 2, and cancer 1). Phase I: OCT images of adenomas had significantly less structure than hyperplastic polyps (Pearson ehi-squared test = 13.1; p = .022), and significantly lower reflectance than hyperplastic polyps (Pearson chi-squared test = 11.2, p=.011). Hyperplastic polyps were significantly closer in reflectance (Pearson chi-squared test = 14.9, p=.011) and organization (Pearson chi-squared test = 12.9, p=.012) to normal colon than adenomas. Phase II: Digital image analysis found significant differences in refleetivity between normal tissue and polyp based on histology. Hyperplastic polyps were significantly closer in reflectance to normal tissue than adenomas (15.9 vs. 43.1), (p=.0013). Conclusions: Using colon adenoma as a model for dysplasia, real time OCT imaging differentiated adenomas, hyperplastic polyps and normal tissue based on reflectance and degree of histologic organization. By OCT imaging, dysplasia appears to have charaeteristic features.
VOLUME 53, NO. 5, 2001
*3424 A NOVEL ENDOSCOPIC FULL THICKNESS PLICATOR FOR THE TREATMENT OF GERD: FEASIBILITY STUDY AND COMPARISON OF EASE OF USE IN CADAVERIC HUMAN AND PIG STOMACHS. Ram Chuttani, Beth Israel Deaconess Medical Ctr, Boston, M.A; Gopal Sachdev, Maulana Azad Medical Coll, New Delhi India; Randhir Sud, Sir Ganga Ram Hosp, New Delhi India; Steven L. Brandwein, Douglas K. Pleskow, Subhas Banerjee, Jonathan Critchlow, Beth Israel Deaconess Medical Ctr, Boston, MA Aim: To assess the feasibility of performing endoscopic full thickness plication using a new endoscopic plication device for GERD and to compare the relative ease of use of the device in cadaveric human and pig stomachs. Methods: A new endoscopic full thickness plication device (NDO Surgical Inc., Mansfield, MA) plicates the wall of the stomach and fixates it with a single pre-tied suture based implant. The device was used to create plications in cadeveric human and pig stomachs. Stomach wall thickness was determined in 5 live patients by EUS. The new plication device was used to perform full thickness tissue plications in a formalin preserved human stomach, 2 fresh cadaveric stomachs, a freshly resected human stomach and 8 pig stomachs. The ease of performing plicatians at different sites near the GE junction was assessed. The stomachs were then dissected to
ABll4
GASTROINTESTINAL ENDOSCOPY
assess the presence of full thickness intraluminal plication bulges, the presence of which denotes a successful result. Results: An average of 2 plications each were performed in 8 pig stomachs, the formalin preserved human stomach and the 2 cadeveric human stomachs. All plications were full thickness resulting in serosa to serosa apposition and satisfactory intraluminal tissue bulges. It was significantly easier to accurately position the plication device and perform plication in cadavaric human stomachs than in pig stomachs, due to anatomical differences. EUS in the 5 live patients determined wall thickness near the GE junction to be between 2.8 and 4.1 mm. The cadaveric human specimens had significantly thinner walls when compared to live human and pig stomachs, possibly due to autolysis. The plication device was subsequently used satisfactorily in the freshly resected human stomach. Conclusions: 1. Full thickness endoscopic plication of the stomach wall near the GE junction using the new endoscopic plication device is feasible in the human stomach. 2. The cadeveric human stomach wall is significantly thinner than the pig stomach, but this does not affect the ability of the device to create satisfactory intraluminal tissue bulges. 3. The positioning of the device and plication are significantly easier to perform in the cadaveric human stomach compared to pig stomachs.
*3425 CRITERIA FOR THE DIAGNOSIS OF DYSPLASIA BY OPTICAL COHERENCE TOMOGRAPHY (OCT) Patrick R. Pfau, Michael V. Sivak Jr, Margaret Kinnard, Univ Hospitals of Cleveland, Cleveland, OH; Joseph Izatt, Andrew M. Rollins, Case Western Reserve Univ, Cleveland, OH; Richard Ck Wang, Univ Hospitals of Cleveland, Cleveland, OH; Volker Westphal, Case Western Reserve Univ, Cleveland, OH; Gerard A. Isenberg, Univ Hospitals of Cleveland, Cleveland, OH AIM: We hypothesized, based on observations in Barrett's esophagus, that dysplastic tissue has characteristic OCT image features that include loss of architectural (histologic) organization and decreased refleetivity. OCT imaging is based on light scattering by tissue. Dysplastic tissue may scatter light differently than normal tissue. To test this hypothesis we used colon polyps as a model of dysplasia and prospectively assessed the ability to differentiate adenoma from non-adenoma by OCT METHODS: OCT images were obtained of polyps in patients undergoing colonoscopy using a circular scanning OCT probe (2 mm focus). Phase I: In real time, endoscopists rated the degree to which OCT images of polyps and normal mucosa exhibited histologic structure (primarily the presence of crypts) on a scale of 0 (none) to 5 (most organized). Reflectivity was rated on a scale of 0 (none) to 5 (highest). Tissue organization and reflectance were compared for adenomas, hyperplastic polyps and normal mucosa (chi-squared analysis). Phase II: Pairs of images were captured digitally for polyps and normal mucosa. A software generated square (60 x 60 pixels) was placed over the digital images and the degree of reflectance within the square computed. Complete reflectance assigned a value of 100, no reflectance a value of 0. Differences between polyps and normal mucosa were assessed by histologic type (Student's t-test). RESULTS: 35 polyps (21 patients; llF, 10 M; mean age 67.2 yrs) were imaged with OCT, removed and classified histologically (adenoma 24, hyperplastic 8, normal mucosa 2, and cancer 1). Phase I: OCT images of adenomas had significantly less structure than hyperplastic polyps (Pearson ehi-squared test = 13.1; p = .022), and significantly lower reflectance than hyperplastic polyps (Pearson chi-squared test = 11.2, p=.011). Hyperplastic polyps were significantly closer in reflectance (Pearson chi-squared test = 14.9, p=.011) and organization (Pearson chi-squared test = 12.9, p=.012) to normal colon than adenomas. Phase II: Digital image analysis found significant differences in refleetivity between normal tissue and polyp based on histology. Hyperplastic polyps were significantly closer in reflectance to normal tissue than adenomas (15.9 vs. 43.1), (p=.0013). Conclusions: Using colon adenoma as a model for dysplasia, real time OCT imaging differentiated adenomas, hyperplastic polyps and normal tissue based on reflectance and degree of histologic organization. By OCT imaging, dysplasia appears to have charaeteristic features.
VOLUME 53, NO. 5, 2001