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A Randomised Comparative Study Between Dilation By Electrocautery Incision and Savary Bougies for Benign Anastomotic Gastro-Esophageal Strictures
Abstracts
Prone vs Left Lateral Colonoscopy in Obese Patients
BMI Time to Cecum (min) Max Pain (0-10) Midazolam (mg) Fentanyl (mcg)
Prone Position
Left-Lateral Position
38 5 1.3 2.4 82
36 11 3.0 2.4 92
p p p p p
! ! ! Z Z
0.05 0.001 0.001 NS NS
months. Three patients with a long-segment stenosis (O 1 cm) experienced a recurrence, and it was statistically significant (P Z .003). Restenosis following treatment occurred in 1.6 month, mean and 2 sessions of treatment were repeated. All procedures were successfully completed within 10 minutes. None of the patients experienced threatening complications such as bleeding or perforation. Conclusions: Endoscopic incisional therapy using an Iso-Tome and an end-viewing endoscope fitted with a transparent hood in patients with anastomotic esophageal strictures is an easy, safe and feasible method for primary treatment. It appears to keep a longer rate of patency than bougie or balloon dilation. However, this study had a limited number of patients and a randomized, controlled study is required to verify these findings.
443 A Randomised Comparative Study Between Dilation By Electrocautery Incision and Savary Bougies for Benign Anastomotic Gastro-Esophageal Strictures Marjan L. Hordijk, Jeanin E. Hooft Van, Bettina E. Hansen, Paul Fockens, E. J. Kuipers
445 Randomized Controlled Study of Endoscopic Mucosal Resection (EMR) Versus Endoscopic Submucosal Dissection with a Waterjet Hybridknife (ESDH) of Esophageal Lesions in a Porcine Model Horst Neuhaus, Katja Wirths, Markus D. Enderle, Brigitte Schumacher
Introduction: A gastro-esophageal anastomosis is complicated by a stricture in 5-46% of patients. With Savary bougies (SB) repeated dilations are often required. Electrocautery incision (EI) has been shown excellent for anastomotic strictures refractory to SB.Study aims: To compare the efficacy of dilation with EI or SB in patients with an anastomotic stricture after esophageal resection with regard to objective and subjective criteria. Methods: Patients with dysphagia grade II (solids) or worse were randomized to EI or SB and followed up after 1, 3 and 6 month. Dilation took place with EI by needle knife incisions (Wilson Cook, Boston Scientific). The minimal diameter was 11 mm in EI and 16 mm in SB. Study endpoint was O5 dilations. Objective (weight change; success rate [percentage of patients with %5 dilations in 6 month]; time interval between dilations) and subjective criteria were compared (dysphagia; saliva, acid, bile regurgitation; coughing; enjoying meal; eating frequency; portion size; pain; patients’ tolerability of the procedure and perception of satisfaction after therapy). Results: 62 patients (50 male, 12 female, aged 41-76, mean 61.7) were randomized to EI or SB. Of the first treatments 75.8% were within 4 month after surgery. No complication of EI or SB was seen. Overall weight change was significant in favour of EI (mean þ0.8 kg vs. mean -2 kg, p Z 0.05). Between EI and SB was no significant difference in success rate (96.2% vs. 80.8%, p Z 0.08) and time interval between dilations (median 6 weeks, 95% confidence interval [CI] 3.1-8.9 vs. median 6 weeks, CI 4.4-7.6, p Z 0.73). Overall estimated stenosis length was significant longer in EI (0.2-5 cm, mean 1.35 vs. 0.2-2 cm, mean 0.55, p ! 0.001). To correct for this skewed distribution we analyzed the group of 17 patients with postoperative complications were the most extreme stenosis lengths were observed and EI and SB showed no significant difference in lengths (0.3-5 cm, mean 2 vs. 0.2-2 cm, mean 0.8, p Z 0.07). In this group EI showed a significant higher success rate (88.9% vs. 37.5%, p Z 0.03) and longer time interval between dilations (median 6 weeks, CI 4.1-7.9 vs. median 4 weeks, CI 3.3-4.7, p Z 0.04). Overall subjective criteria improved significant after therapy in both groups (p Z 0.03-p ! 0.001), though with EI patients’ tolerability of the procedure and perception of satisfaction after therapy were significant better (p Z 0.001, p Z 0.002). Conclusion: Overall patients with anastomotic esophageal strictures preferred EI above SB. Weight change was in favour of EI. Patients with postoperative complications needed less dilations and the time interval between dilations was longer with EI.
Introduction: Uncontrolled studies indicated that ESD is superior to EMR for enbloc resection of gastrointestinal mucosal lesions. However, ESD is technically difficult and seems to be more time-consuming and hazardous than EMR. In addition experience with this method is limited in the esophagus although there may be more clinical applications for esophageal lesions than for gastric lesions in Western countries. The objective of our study is to compare a new simplified ESD technique with conventional EMR. Methods and aims: The study was performed in 6 pigs under general anesthesia. A total of 25 esophageal areas with a diameter of 20 mm were marked with coagulation spots. These lesions were then randomized to either EMR by use of the cap technique or ESD. Submucosal injection of saline solution was used for both methods. ESD was done with a hybrid knife which allows cutting / coagulation as well as injection / flushing through an axial water-jet channel with a preselected pressure of a high pressure waterjet system (Erbe Jet 2). Intraoperative bleedings were treated with hemostatic forceps. Primary objective: to achieve complete resection of the lesions including the coagulation markers with no mucosal bridges; secondary objectives: to minimize the number of specimen, to determine the complication rate and procedural duration. Results: 13 lesions were randomized to EMRC and 12 to ESDH. ESDH achieved complete resection significantly more frequently than EMRC (10/12 versus 6/13 p Z 0.05). All ESDH resections were performed as a single piece whereas a mean ( SD) of 2.5 0.9 resections were needed for EMRC (p ! 0.05). Mean areas of the specimen were 4.7 0.7 cm2 in the ESDH group and 3.7 1.2 cm2 in the EMRC group (p ! 0.04). ESDH was performed with a larger amount of fluid for injection/flushing compared to EMRC (78.1 32.8 ml vs 20.9 7.6 ml; p ! 0.001). The procedural duration was longer for ESDH than for EMRC (28.2 11.9 min vs 12.2 4.9 min; p ! 0.001). ESDH and EMRC caused bleedings in 6/12 and 5/13 (p Z 0.09) of the cases, respectively. Hemostasis could be achieved in all cases. There was no perforation in both groups. Conclusions: This randomized controlled trial shows that ESDH significantly achieves complete resection of esophageal lesions more frequently with less number of specimen than EMRC. ESDH is more time-consuming but the procedural duration seems to be shorter than conventional ESD because there is no need for exchange of devices for injection and cutting. The easy use of water-jet assisted injection of large amount of fluids may explain that ESDH was as safe as EMRC in spite of the thin esophageal wall in a porcine model.
444 Endoscopic Incisional Therapy with Iso-Tome and Transparent Hood in Patients with Benign Anastomotic Esophageal Stricture Tae Hoon Lee, Suck-Ho Lee, Ji-Young Park, Jeong Hoon Park, Do Hyun Park, Il Kwun Chung, Hong-Soo Kim, Sang-Heum Park, Sun-Joo Kim, Su Jin Hong, Moon Sung Lee Background: Benign anastomotic stricture of the esophagus following surgical resection has been reported to occur in 5% to 46% of patients. There is a significant recurrence rate in bougie, or balloon dilation, which requires repeated dilation sessions to maintain the patency. Electrocautery treatment was proposed to be a good alternative treatment in several studies. Aim: Our study evaluated the efficacy of endoscopic incisional therapy using an Iso-Tome and an end-viewing endoscope fitted with a transparent hood in patients with benign anastomotic esophageal strictures, prospectively. Materials and Methods: A total of 24 patients having benign anastomotic esophageal strictures after total gastrectomy with gastrojejunostomy were treated with endoscopic incisional therapy using Iso-Tome under direct vision through a transparent hood to ensure a safety-margin. Radial incisions parallel to the longitude of the esophagus were carefully performed by pulling up the Iso-Tome, and terminated when the endoscope could easily pass without pressure to the stricture. The number (8-10 incisions) and the length of incisions were quantified to completely remove the rim of the stenosis. Clinical evaluation and EGD were carried out for every patient one month later and then followed-up during the next 18 months. Results: All 21 patients with a stricture shorter than 1cm in length were dilated successfully following a single incisional treatment, and it was not necessary to repeat the sessions during the following 18
AB90 GASTROINTESTINAL ENDOSCOPY Volume 67, No. 5 : 2008
446 A New Transoral Gastroplasty Device for GERD and Obesity Rudolf J. Stadlhuber, Fumiaki Yano, Sumeet K. Mittal, Raul J. Rosenthal, Richard I. Rothstein, Charles J. Filipi Background: Gastro-esophageal-reflux-disease and morbid obesity are significant health problems in the western world and are associated with morbidities and increasing costs. The common surgical therapy is either a laparoscopic or open operation. We are developing a device that allows a physician to create an endoscopic, full-thickness gastroplasty under conscious sedation; the primary goals being efficacy and durability of effect by reducing the diameter of the gastroesophageal junction (GERD) or the stomach volume (obesity). Methods: The gastroplasty is formed by a new dilator shaped device (SafesStitch Medical Inc.). The instrument consists of a flexible tube with an integrated excision and suture capsule on the distal end. A standard small caliber transnasal endoscope is introduced through the device for direct observation. A rigid distal capsule measuring 5 2cm in diameter contains a guillotine excision blade, vertical anchor needles for tissue holding and Adrenalin injection, and two needles each connected to a separate suture running through the device. Four full-thickness sutures are placed and two mucosal excisions down to the level of the muscularis propria are used for each stage of the gastroplasty. After correct positioning of the device under direct endoscopic visualization the gastric wall is pulled into the trough with 180 mm/Hg negative pressure. The two three-quarter-circle needles are actuated to rotate 360 through the captured tissue. The tissue is then injected with 8 cc of 1:200,000 adrenalin-solution to create tissue swelling for a safe cut in the correct gastric wall layer and hemostasis. The second suture excision cycle is performed by turning the device into the correct position and repeating the sequence. The
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Prone vs Left Lateral Colonoscopy in Obese Patients
BMI Time to Cecum (min) Max Pain (0-10) Midazolam (mg) Fentanyl (mcg)
Prone Position
Left-Lateral Position
38 5 1.3 2.4 82
36 11 3.0 2.4 92
p p p p p
! ! ! Z Z
0.05 0.001 0.001 NS NS
months. Three patients with a long-segment stenosis (O 1 cm) experienced a recurrence, and it was statistically significant (P Z .003). Restenosis following treatment occurred in 1.6 month, mean and 2 sessions of treatment were repeated. All procedures were successfully completed within 10 minutes. None of the patients experienced threatening complications such as bleeding or perforation. Conclusions: Endoscopic incisional therapy using an Iso-Tome and an end-viewing endoscope fitted with a transparent hood in patients with anastomotic esophageal strictures is an easy, safe and feasible method for primary treatment. It appears to keep a longer rate of patency than bougie or balloon dilation. However, this study had a limited number of patients and a randomized, controlled study is required to verify these findings.
443 A Randomised Comparative Study Between Dilation By Electrocautery Incision and Savary Bougies for Benign Anastomotic Gastro-Esophageal Strictures Marjan L. Hordijk, Jeanin E. Hooft Van, Bettina E. Hansen, Paul Fockens, E. J. Kuipers
445 Randomized Controlled Study of Endoscopic Mucosal Resection (EMR) Versus Endoscopic Submucosal Dissection with a Waterjet Hybridknife (ESDH) of Esophageal Lesions in a Porcine Model Horst Neuhaus, Katja Wirths, Markus D. Enderle, Brigitte Schumacher
Introduction: A gastro-esophageal anastomosis is complicated by a stricture in 5-46% of patients. With Savary bougies (SB) repeated dilations are often required. Electrocautery incision (EI) has been shown excellent for anastomotic strictures refractory to SB.Study aims: To compare the efficacy of dilation with EI or SB in patients with an anastomotic stricture after esophageal resection with regard to objective and subjective criteria. Methods: Patients with dysphagia grade II (solids) or worse were randomized to EI or SB and followed up after 1, 3 and 6 month. Dilation took place with EI by needle knife incisions (Wilson Cook, Boston Scientific). The minimal diameter was 11 mm in EI and 16 mm in SB. Study endpoint was O5 dilations. Objective (weight change; success rate [percentage of patients with %5 dilations in 6 month]; time interval between dilations) and subjective criteria were compared (dysphagia; saliva, acid, bile regurgitation; coughing; enjoying meal; eating frequency; portion size; pain; patients’ tolerability of the procedure and perception of satisfaction after therapy). Results: 62 patients (50 male, 12 female, aged 41-76, mean 61.7) were randomized to EI or SB. Of the first treatments 75.8% were within 4 month after surgery. No complication of EI or SB was seen. Overall weight change was significant in favour of EI (mean þ0.8 kg vs. mean -2 kg, p Z 0.05). Between EI and SB was no significant difference in success rate (96.2% vs. 80.8%, p Z 0.08) and time interval between dilations (median 6 weeks, 95% confidence interval [CI] 3.1-8.9 vs. median 6 weeks, CI 4.4-7.6, p Z 0.73). Overall estimated stenosis length was significant longer in EI (0.2-5 cm, mean 1.35 vs. 0.2-2 cm, mean 0.55, p ! 0.001). To correct for this skewed distribution we analyzed the group of 17 patients with postoperative complications were the most extreme stenosis lengths were observed and EI and SB showed no significant difference in lengths (0.3-5 cm, mean 2 vs. 0.2-2 cm, mean 0.8, p Z 0.07). In this group EI showed a significant higher success rate (88.9% vs. 37.5%, p Z 0.03) and longer time interval between dilations (median 6 weeks, CI 4.1-7.9 vs. median 4 weeks, CI 3.3-4.7, p Z 0.04). Overall subjective criteria improved significant after therapy in both groups (p Z 0.03-p ! 0.001), though with EI patients’ tolerability of the procedure and perception of satisfaction after therapy were significant better (p Z 0.001, p Z 0.002). Conclusion: Overall patients with anastomotic esophageal strictures preferred EI above SB. Weight change was in favour of EI. Patients with postoperative complications needed less dilations and the time interval between dilations was longer with EI.
Introduction: Uncontrolled studies indicated that ESD is superior to EMR for enbloc resection of gastrointestinal mucosal lesions. However, ESD is technically difficult and seems to be more time-consuming and hazardous than EMR. In addition experience with this method is limited in the esophagus although there may be more clinical applications for esophageal lesions than for gastric lesions in Western countries. The objective of our study is to compare a new simplified ESD technique with conventional EMR. Methods and aims: The study was performed in 6 pigs under general anesthesia. A total of 25 esophageal areas with a diameter of 20 mm were marked with coagulation spots. These lesions were then randomized to either EMR by use of the cap technique or ESD. Submucosal injection of saline solution was used for both methods. ESD was done with a hybrid knife which allows cutting / coagulation as well as injection / flushing through an axial water-jet channel with a preselected pressure of a high pressure waterjet system (Erbe Jet 2). Intraoperative bleedings were treated with hemostatic forceps. Primary objective: to achieve complete resection of the lesions including the coagulation markers with no mucosal bridges; secondary objectives: to minimize the number of specimen, to determine the complication rate and procedural duration. Results: 13 lesions were randomized to EMRC and 12 to ESDH. ESDH achieved complete resection significantly more frequently than EMRC (10/12 versus 6/13 p Z 0.05). All ESDH resections were performed as a single piece whereas a mean ( SD) of 2.5 0.9 resections were needed for EMRC (p ! 0.05). Mean areas of the specimen were 4.7 0.7 cm2 in the ESDH group and 3.7 1.2 cm2 in the EMRC group (p ! 0.04). ESDH was performed with a larger amount of fluid for injection/flushing compared to EMRC (78.1 32.8 ml vs 20.9 7.6 ml; p ! 0.001). The procedural duration was longer for ESDH than for EMRC (28.2 11.9 min vs 12.2 4.9 min; p ! 0.001). ESDH and EMRC caused bleedings in 6/12 and 5/13 (p Z 0.09) of the cases, respectively. Hemostasis could be achieved in all cases. There was no perforation in both groups. Conclusions: This randomized controlled trial shows that ESDH significantly achieves complete resection of esophageal lesions more frequently with less number of specimen than EMRC. ESDH is more time-consuming but the procedural duration seems to be shorter than conventional ESD because there is no need for exchange of devices for injection and cutting. The easy use of water-jet assisted injection of large amount of fluids may explain that ESDH was as safe as EMRC in spite of the thin esophageal wall in a porcine model.
444 Endoscopic Incisional Therapy with Iso-Tome and Transparent Hood in Patients with Benign Anastomotic Esophageal Stricture Tae Hoon Lee, Suck-Ho Lee, Ji-Young Park, Jeong Hoon Park, Do Hyun Park, Il Kwun Chung, Hong-Soo Kim, Sang-Heum Park, Sun-Joo Kim, Su Jin Hong, Moon Sung Lee Background: Benign anastomotic stricture of the esophagus following surgical resection has been reported to occur in 5% to 46% of patients. There is a significant recurrence rate in bougie, or balloon dilation, which requires repeated dilation sessions to maintain the patency. Electrocautery treatment was proposed to be a good alternative treatment in several studies. Aim: Our study evaluated the efficacy of endoscopic incisional therapy using an Iso-Tome and an end-viewing endoscope fitted with a transparent hood in patients with benign anastomotic esophageal strictures, prospectively. Materials and Methods: A total of 24 patients having benign anastomotic esophageal strictures after total gastrectomy with gastrojejunostomy were treated with endoscopic incisional therapy using Iso-Tome under direct vision through a transparent hood to ensure a safety-margin. Radial incisions parallel to the longitude of the esophagus were carefully performed by pulling up the Iso-Tome, and terminated when the endoscope could easily pass without pressure to the stricture. The number (8-10 incisions) and the length of incisions were quantified to completely remove the rim of the stenosis. Clinical evaluation and EGD were carried out for every patient one month later and then followed-up during the next 18 months. Results: All 21 patients with a stricture shorter than 1cm in length were dilated successfully following a single incisional treatment, and it was not necessary to repeat the sessions during the following 18
AB90 GASTROINTESTINAL ENDOSCOPY Volume 67, No. 5 : 2008
446 A New Transoral Gastroplasty Device for GERD and Obesity Rudolf J. Stadlhuber, Fumiaki Yano, Sumeet K. Mittal, Raul J. Rosenthal, Richard I. Rothstein, Charles J. Filipi Background: Gastro-esophageal-reflux-disease and morbid obesity are significant health problems in the western world and are associated with morbidities and increasing costs. The common surgical therapy is either a laparoscopic or open operation. We are developing a device that allows a physician to create an endoscopic, full-thickness gastroplasty under conscious sedation; the primary goals being efficacy and durability of effect by reducing the diameter of the gastroesophageal junction (GERD) or the stomach volume (obesity). Methods: The gastroplasty is formed by a new dilator shaped device (SafesStitch Medical Inc.). The instrument consists of a flexible tube with an integrated excision and suture capsule on the distal end. A standard small caliber transnasal endoscope is introduced through the device for direct observation. A rigid distal capsule measuring 5 2cm in diameter contains a guillotine excision blade, vertical anchor needles for tissue holding and Adrenalin injection, and two needles each connected to a separate suture running through the device. Four full-thickness sutures are placed and two mucosal excisions down to the level of the muscularis propria are used for each stage of the gastroplasty. After correct positioning of the device under direct endoscopic visualization the gastric wall is pulled into the trough with 180 mm/Hg negative pressure. The two three-quarter-circle needles are actuated to rotate 360 through the captured tissue. The tissue is then injected with 8 cc of 1:200,000 adrenalin-solution to create tissue swelling for a safe cut in the correct gastric wall layer and hemostasis. The second suture excision cycle is performed by turning the device into the correct position and repeating the sequence. The
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