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Endoluminal Closure of Large Perforations of Colon with Clips in a Porcine Model
Abstracts
T1472 EsophyXÔ Endoluminal Fundoplication for the Treatment of Severe Chronic GERD: Multiple Tissue Fasteners Secure Valvuloplasty As Demonstrated in an Animal Model Stefan J. Kraemer, Richard a. Kozarek, Brett J. Carter, Donald E. Low Background: Previous work has suggested that the anatomy of the gastroesophageal junction can help define propensity to reflux. Most currently published endoluminal approaches reportedly use a single fastener approach. Historically, the ‘‘one-stitch Nissen’’ lead to failure of creating a lasting antireflux procedure with a single stitch, which doesn’t result in a tension-free suture (line) and appropriate and sufficient fusion of the serosal surfaces in the area of the wrap. This study was designed to demonstrate efficacy and safety of a multiple fastener approach applied with a novel flexible endoluminal fundoplication device and method. Method: Dogs naturally have a very lose gastroesophageal junction including a weak LES. A gastroesophageal valve is mostly absent in healthy dogs. In retroflexed endoscopic view the canine valve appearance closely resembles the poor or absent valve in patients with severe chronic GERD. In a GLP setting 19 mongrel dogs were treated with an endoluminal fundoplication in order to create a robust gastroesophageal valve (GEV) at the gastroesophageal junction, using proprietary polypropylene tissue fasteners. Endoscopic follow-up time at was 4, respectively 12 weeks. Observations: Following tissue retraction, a median of 8 tissues fasteners were placed endoluminally transgastrically with a novel endoluminal fundoplication device at the gastroesophageal junction to secure the newly created antireflux valve by approximating and fastening the two serosal surfaces. The number of fasteners placed ranged from 5 to 13. Fewer fasteners resulted typically in a flap valve, while the application of more tissue fasteners resulted in an omega-shaped nipple valve. All valves largely retained their shape and length over the time of the study. Upon resection, the intra- and extragastric appearance of the fasteners, which had been placed approximately 0.5-2 cm apart from each other, was similar to the suture or staple lines created in open or laparoscopic surgery. Conclusions: Like in surgery placement of more than one fastener is beneficial for the longevity of an anastomosis or anatomical tissue reconfiguration.
T1473 D50 Is Superior to Normal Saline As Medium for Endoscopic Mucosal Resection Shyam Varadarajulu, Robert Slaughter Background: Endoscopic mucosal resection (EMR) traditionally is performed by using normal saline (NS) as the submucosal fluid cushion. However, NS being isotonic does not maintain mucosal elevation for prolonged periods. We hypothesized that Dextrose 50% (D50) being a hypertonic solution would be an ideal medium for EMR. The efficacy and safety of D50 for performing EMR was assessed. Methods: This is a prospective randomized study of all patients undergoing gastroscopy or colonoscopy who underwent EMR. EUS was done prior to EMR in all patients who underwent gastroscopy. Patients were randomized to receive either NS or D50 as the submucosal fluid cushion. The endoscopist was blinded to the nature of solution injected. The volume of solution and number of sites injected to elevate the lesion, no. of times EMR was interrupted to inject more fluid to maintain elevation, rates of en bloc (one piece resection) and complete (removal of the entire lesion at one endoscopy session) resections, and complication rates between both groups were evaluated. Mean follow-up was 6 months. Results: 52 sessile lesions were removed in 50 patients. Locations were esophagus (1), stomach (14), duodenum (9), rectum (3), left colon (8), and right colon (17). Post-EMR histopathology was adenomatous polyp (19), tubulovillous polyp (14), hyperplastic polyp (10), gastric carcinoma-in-situ (1), Tis colon cancer (1), lipoma (2), serrated polyp (3), granular cell tumor (1), and carcinoid (1). The submucosal area remained elevated even after completion of EMR in 96% of patients randomized to D50 versus 20% with NS (p ! 0.001). Four patients randomized to NS experienced resection-related bleeding that was managed endoscopically. At follow-up, recurrence rates between groups were not significantly different. SUMMARY: 1) D50 has a good safety profile. 2) D50 is
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superior to NS by maintaining better submucosal elevation for prolonged periods with lesser volume and fewer number of injections. 3) Technical outomes, such as en-bloc resection rates, were better with D50 than with NS. Conclusions: D50, an easily available and inexpensive solution, is superior to normal saline as medium for endoscopic mucosal resection. Variables
D50 (n Z 27)
NS (n Z 25)
25 5.6 1
22 7 2
0.4 0.02 0.003
4
25
0.04
81 96 0 4
44 80 16 16
0.01 0.09 0.05 0.7
Lesion size (mean, mm) Vol. injected (median, cc) No. of sites injected around lesion to attain elevation (median) Intermittent injections during EMR to maintain elevation (%) En-bloc EMR (%) Complete EMR (%) Bleeding (%) Recurrence rate (%)
p
T1474 Endoluminal Closure of Large Perforations of Colon with Clips in a Porcine Model Gottumukkala S. Raju, Ijaz Ahmed, Douglas Brining, Shu-Yuan Xiao Background: Very little is known about endoluminal closure of colon perforations with clips. We have shown that endoluminal closure of small perforations of the colon is successful using clips in a porcine model (GIE 2005;62:791-95). It was unclear whether large perforations of colon can also be closed successfully with clips deployed through a colonoscope. Aims: The aims of this study were to evaluate technical feasibility & outcome of endoluminal closure of large perforations of colon with clips. Methods: This was an animal experimental study of endoluminal closure of large perforations of colon (R5 cm) with Resolution Clips (Boston Scientific) in 8 pigs. a) Technical Feasibility of Endoluminal Closure: Evaluated in 8 animals. b) Quality of Endoluminal Closure: Assessed by dye leak test immediately after closure & 2 weeks after closure. c) Clinical Monitoring: Animals in the survival group were monitored daily for 2 weeks for clinical signs of sepsis & peritonitis. d) Necropsy: Immediately (n Z 4) & 2 weeks after closure (n Z 4) to check for fecal peritonitis, inspect the colon perforation site for apposition/healing, culture peritoneal fluid & microscopy of the site to examine histological healing of perforation. Results: Endoscopic closure of colon perforation was successful in 6 of 8 animals. Clip closure resulted in a leak proof sealing & prevented fecal peritonitis, sepsis, pericolic abscess formation. The perforation site demonstrated a thin scar & there was histological healing as well. Endoscopic closure of colon perforation was unsuccessful due to prolapse of adjacent viscera into the colon (n Z 1) & severe bleeding that obscured the view (n Z 1). Results were summarized in tables 1 & 2. Conclusions: Endoluminal application of clips is successful in the closure of large perforations of colon in a porcine model. Table 1. Results of endoluminal closure of large perforations of colon with clips - acute non-survival study Endoluminal Closure
Necropsy
Leak Peritoneal Serosal side of Clips @ Clips Proof perforation Perforation applied end of Successful Closure Cavity serosal apposition Seal expt. of Perforation (n) S. No (cm) 1 2
7 4
20 3
20 3
Cve -ve
3 4
5 5
4 16
4 16
-ve Cve
Clean Blood C Stool Stool Clean
Cve -ve
Cve )
-ve -ve
) Cve
)Leak test not done. Table 2. Results of endoluminal closure of large perforations of colon with clips - 2 week survival study Endoluminal Closure
Necropsy
Peritoneal Paracoic Clips Clips Gutter cavity applied @ 2 Fluid - Fibrin wks Successful Clinical Perforation (scant) Closure Peritonitis S. No (cm)
Serosal Leak Side of Perforation Proof Seal - Scar
1 2 3 4
Cve Cve Cve Cve
4 5 5 5
6 7 7 7
3 3 3 5
Cve Cve Cve Cve
-ve -ve -ve -ve
Cve Cve -ve -ve
Staph Staph E.coli E.coli C Staph
Cve Cve ) Cve
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB235
T1472 EsophyXÔ Endoluminal Fundoplication for the Treatment of Severe Chronic GERD: Multiple Tissue Fasteners Secure Valvuloplasty As Demonstrated in an Animal Model Stefan J. Kraemer, Richard a. Kozarek, Brett J. Carter, Donald E. Low Background: Previous work has suggested that the anatomy of the gastroesophageal junction can help define propensity to reflux. Most currently published endoluminal approaches reportedly use a single fastener approach. Historically, the ‘‘one-stitch Nissen’’ lead to failure of creating a lasting antireflux procedure with a single stitch, which doesn’t result in a tension-free suture (line) and appropriate and sufficient fusion of the serosal surfaces in the area of the wrap. This study was designed to demonstrate efficacy and safety of a multiple fastener approach applied with a novel flexible endoluminal fundoplication device and method. Method: Dogs naturally have a very lose gastroesophageal junction including a weak LES. A gastroesophageal valve is mostly absent in healthy dogs. In retroflexed endoscopic view the canine valve appearance closely resembles the poor or absent valve in patients with severe chronic GERD. In a GLP setting 19 mongrel dogs were treated with an endoluminal fundoplication in order to create a robust gastroesophageal valve (GEV) at the gastroesophageal junction, using proprietary polypropylene tissue fasteners. Endoscopic follow-up time at was 4, respectively 12 weeks. Observations: Following tissue retraction, a median of 8 tissues fasteners were placed endoluminally transgastrically with a novel endoluminal fundoplication device at the gastroesophageal junction to secure the newly created antireflux valve by approximating and fastening the two serosal surfaces. The number of fasteners placed ranged from 5 to 13. Fewer fasteners resulted typically in a flap valve, while the application of more tissue fasteners resulted in an omega-shaped nipple valve. All valves largely retained their shape and length over the time of the study. Upon resection, the intra- and extragastric appearance of the fasteners, which had been placed approximately 0.5-2 cm apart from each other, was similar to the suture or staple lines created in open or laparoscopic surgery. Conclusions: Like in surgery placement of more than one fastener is beneficial for the longevity of an anastomosis or anatomical tissue reconfiguration.
T1473 D50 Is Superior to Normal Saline As Medium for Endoscopic Mucosal Resection Shyam Varadarajulu, Robert Slaughter Background: Endoscopic mucosal resection (EMR) traditionally is performed by using normal saline (NS) as the submucosal fluid cushion. However, NS being isotonic does not maintain mucosal elevation for prolonged periods. We hypothesized that Dextrose 50% (D50) being a hypertonic solution would be an ideal medium for EMR. The efficacy and safety of D50 for performing EMR was assessed. Methods: This is a prospective randomized study of all patients undergoing gastroscopy or colonoscopy who underwent EMR. EUS was done prior to EMR in all patients who underwent gastroscopy. Patients were randomized to receive either NS or D50 as the submucosal fluid cushion. The endoscopist was blinded to the nature of solution injected. The volume of solution and number of sites injected to elevate the lesion, no. of times EMR was interrupted to inject more fluid to maintain elevation, rates of en bloc (one piece resection) and complete (removal of the entire lesion at one endoscopy session) resections, and complication rates between both groups were evaluated. Mean follow-up was 6 months. Results: 52 sessile lesions were removed in 50 patients. Locations were esophagus (1), stomach (14), duodenum (9), rectum (3), left colon (8), and right colon (17). Post-EMR histopathology was adenomatous polyp (19), tubulovillous polyp (14), hyperplastic polyp (10), gastric carcinoma-in-situ (1), Tis colon cancer (1), lipoma (2), serrated polyp (3), granular cell tumor (1), and carcinoid (1). The submucosal area remained elevated even after completion of EMR in 96% of patients randomized to D50 versus 20% with NS (p ! 0.001). Four patients randomized to NS experienced resection-related bleeding that was managed endoscopically. At follow-up, recurrence rates between groups were not significantly different. SUMMARY: 1) D50 has a good safety profile. 2) D50 is
www.giejournal.org
superior to NS by maintaining better submucosal elevation for prolonged periods with lesser volume and fewer number of injections. 3) Technical outomes, such as en-bloc resection rates, were better with D50 than with NS. Conclusions: D50, an easily available and inexpensive solution, is superior to normal saline as medium for endoscopic mucosal resection. Variables
D50 (n Z 27)
NS (n Z 25)
25 5.6 1
22 7 2
0.4 0.02 0.003
4
25
0.04
81 96 0 4
44 80 16 16
0.01 0.09 0.05 0.7
Lesion size (mean, mm) Vol. injected (median, cc) No. of sites injected around lesion to attain elevation (median) Intermittent injections during EMR to maintain elevation (%) En-bloc EMR (%) Complete EMR (%) Bleeding (%) Recurrence rate (%)
p
T1474 Endoluminal Closure of Large Perforations of Colon with Clips in a Porcine Model Gottumukkala S. Raju, Ijaz Ahmed, Douglas Brining, Shu-Yuan Xiao Background: Very little is known about endoluminal closure of colon perforations with clips. We have shown that endoluminal closure of small perforations of the colon is successful using clips in a porcine model (GIE 2005;62:791-95). It was unclear whether large perforations of colon can also be closed successfully with clips deployed through a colonoscope. Aims: The aims of this study were to evaluate technical feasibility & outcome of endoluminal closure of large perforations of colon with clips. Methods: This was an animal experimental study of endoluminal closure of large perforations of colon (R5 cm) with Resolution Clips (Boston Scientific) in 8 pigs. a) Technical Feasibility of Endoluminal Closure: Evaluated in 8 animals. b) Quality of Endoluminal Closure: Assessed by dye leak test immediately after closure & 2 weeks after closure. c) Clinical Monitoring: Animals in the survival group were monitored daily for 2 weeks for clinical signs of sepsis & peritonitis. d) Necropsy: Immediately (n Z 4) & 2 weeks after closure (n Z 4) to check for fecal peritonitis, inspect the colon perforation site for apposition/healing, culture peritoneal fluid & microscopy of the site to examine histological healing of perforation. Results: Endoscopic closure of colon perforation was successful in 6 of 8 animals. Clip closure resulted in a leak proof sealing & prevented fecal peritonitis, sepsis, pericolic abscess formation. The perforation site demonstrated a thin scar & there was histological healing as well. Endoscopic closure of colon perforation was unsuccessful due to prolapse of adjacent viscera into the colon (n Z 1) & severe bleeding that obscured the view (n Z 1). Results were summarized in tables 1 & 2. Conclusions: Endoluminal application of clips is successful in the closure of large perforations of colon in a porcine model. Table 1. Results of endoluminal closure of large perforations of colon with clips - acute non-survival study Endoluminal Closure
Necropsy
Leak Peritoneal Serosal side of Clips @ Clips Proof perforation Perforation applied end of Successful Closure Cavity serosal apposition Seal expt. of Perforation (n) S. No (cm) 1 2
7 4
20 3
20 3
Cve -ve
3 4
5 5
4 16
4 16
-ve Cve
Clean Blood C Stool Stool Clean
Cve -ve
Cve )
-ve -ve
) Cve
)Leak test not done. Table 2. Results of endoluminal closure of large perforations of colon with clips - 2 week survival study Endoluminal Closure
Necropsy
Peritoneal Paracoic Clips Clips Gutter cavity applied @ 2 Fluid - Fibrin wks Successful Clinical Perforation (scant) Closure Peritonitis S. No (cm)
Serosal Leak Side of Perforation Proof Seal - Scar
1 2 3 4
Cve Cve Cve Cve
4 5 5 5
6 7 7 7
3 3 3 5
Cve Cve Cve Cve
-ve -ve -ve -ve
Cve Cve -ve -ve
Staph Staph E.coli E.coli C Staph
Cve Cve ) Cve
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB235