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Treatment of Acute Malignant Colorectal Obstruction with WallflexTM Colonic Stents: A Prospective Study
Abstracts
T1527 Efficacy and Safety of Self Expanding Metal Stent (SEMS) in Patients with Malignant Upper Gastrointestinal Obstruction and Associated Factors with Stent Patency Joing Pil IM, Jung Mook Kang, Soo-Jeong Cho, Byong Duk Ye, Sang Gyun Kim, Joo Sung Kim, Hyun Chae Jung, in Sung Song Background/Aims: Malignant upper gastrointestinal (GI) obstruction caused by advanced or inoperable neoplasm seriously impairs the quality of the patient’s life. Self expanding metal stent (SEMS) has known to be an effective and safe device for palliation of malignant esophageal, esophagogastric junction (EGJ), and gastric outlet (GO) obstruction. However, few studies have reported the long-term primary stent patency and the associated factors. The aims of this study were to evaluate the clinical outcomes including technical and clinical success rate and the associated factors with stent patency. Patients and Methods: A total of 77 consecutive patients who underwent endoscopic SEMS (MI techÒ, Seoul, Korea) placement to alleviate upper GI obstruction with unresectable malignancy were retrospectively reviewed in Seoul National University Hospital between April 2005 and August 2006. Clinical outcomes, complications and patency rate were assessed according to the site of obstruction and the stent type. Results: A total of 77 patients (66 men, mean age 62.1 years, range 37-84) underwent 105 SEMS placements. The site of obstruction was esophagus in 25 patients, EGJ in 15 and GO in 37, respectively. Patients with esophageal and EGJ obstruction were treated with covered stent (CS) and CS with anti-reflux valve, respectively. Twenty patients (54.1%) with GO obstruction were treated with CS. Technical success was achieved in 99% (104/105) and clinical success in 87.5% (91/104). The median stent patency time was 186.4 days with a mean follow up for 114.5 days (range 3-428 d) for 75 patients. Primary stent patency rates of esophagus and EGJ were 95.7%, 79.5%, and 66.3% at 30-, 90-, and 180-day, respectively, and were significantly higher than 80.1%, 56.6%, and 36.4% of GO (p Z 0.008). Re-obstruction by tumor overgrowth or ingrowth developed in 20.6% and was higher in GO than in esophagus or EGJ (27.3% vs. 12.8%, p Z 0.07). In patients with GO obstruction, overgrowth occurred more frequently with CS than with uncovered stents (33.3% vs. 9.7%, p Z 0.04). Migration of the stent occurred in 7.8% and was not significantly different in relation to site of obstruction and stent type. The majority of patients with reobstruction or migration were managed by placement of another SEMS (96.6%). There was no perforation, significant bleeding or procedure-related mortality. Conclusions: Endoscopic SEMS placement is an effective and safe palliative treatment for malignant upper GI obstruction and the stent patency is different in relation to site of obstruction and stent type.
T1528 Comparative Performance of Submucosal Fluid Injection with Hydroxypropyl Metylcellulose 0.25%, Carboxymethylcellulose 0.5% and Normal Saline Solution in a Porcine Model Luciano Lenz, Veruska Di Sena, Fernanda Thuler, Rodrigo Azevedo, Marcus Dos Santos, Frank Nakao, Gustavo De Paulo, Ermelindo Libera, Maria Rachel Rohr, Angelo P. Ferrari Background: Endoscopic mucosal resection (EMR) is an established modality for excision of sessile lesions in the gastrointestinal tract. Injection of fluid into the submucosa creates a submucosal fluid cushion and protects from thermal injury and the risk for perforation. This blinded study investigated the performance of three different solutions to create submucosal fluid cushions in a porcine stomach. Methods: Nine minipigs BR1 were studied in this blinded study. Injected solutions were: normal saline solution (NSS), carboxymethylcellulose 0.5% (CMC) and hydroxypropyl methylcellulose 0.25% (HPMC). In each pig, three 6 ml submucosal injections of each solution were used with one drop of methylene blue for better visualization. The time for the bleb to disappear was recorded. Results: The overall median time submucosal for fluid cushion was 37 minutes (range 12-60) for HPMC, 31 minutes for CMC (range 10-43) and 19 minutes for NSS (range 8-37). There was no significant difference in NSS and CMC (p Z 0,146) and either between CMC and HPMC (p Z 0,119) but the median duration of HPMC was significantly longer than NSS (p Z 0,039). Conclusions: The length of HPMC submucosal fluid cushion is longer in comparison with NSS. The median time for CMC was not significantly longer than NSS. HPMC in the concentration of 0.25% may be an inexpensive and available alternative for submucosal injections.
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T1529 Treatment of Acute Malignant Colorectal Obstruction with WallflexTM Colonic Stents: A Prospective Study Giuseppe De Caro, Alessandro Repici, Salvatore Comunale, Vincenzo Cennamo, Carlo Fabbri, Paoletta Preatoni, Nico Pagano, Cristina M. Hervoso, Silvio Danese, Carmelo Luigiano, Tommaso Stefanelli, Alberto Malesci Background: Colonic stenting may serve as a bridge to surgery. Alternatively, in patients who are not candidates for surgery, colonic stenting may be performed for palliation. The aim of this prospective study was to evaluate the efficacy and safety of the new WallflexTM colonic stents for acute bowel obstruction due to primary or recurrent colonic adenocarcinoma. Methods: from May 2004 to September 2006, patients with malignant large bowel occlusion were included in the study. Study was approved by the EC and patients gave informed consent. Exclusion criteria consisted of: benign stricture; perforated colon; extrinsic compressive tumor; concurrent radiotherapy for the colorectal stricture or treatment with an investigational drug or device within the preceding 4 weeks; placement of another metal stent for the same stricture. The presence of large bowel obstruction was confirmed by erect and supine abdominal X-rays and CT scan. Results: SEMS insertion was performed in 40 consecutive patients (17 females, 23 males, mean age 72.2 years with a range of 53 to 92 years). Technical and clinical success was obtained in 36 of 40 patients (92,5%). Failures were due to: stent misplacement; no expansion of the stent; impossibility to pass through the stricture. The distribution of malignant stenosis was as follows: rectum (n Z 7, 17.5%), sigmoid colon (n Z 18, 45%), descending colon (n Z 9, 22.5%), splenic flexure (n Z 2, 5%), transverse colon (n Z 2, 5%) and hepatic flexure (n Z 2, 5%). Colonic stenting was performed as bridge to surgery in 18 patients (45%) and as palliative treatment in 22 patients (55%). Early complications (within 1 week after SEMS placement) occurred in 2 patients: one colon perforation and one stent occlusion for stool impaction. Long-term complications occurred in 6 patients: 1 stent occlusion for fecal impaction, 2 for tumor ingrowth and 1 for tumor overgrowth and 1 rectal bleeding. The mean time between stent placement and surgery was 5.2 days (range, 2-12). There were not surgery complications. At the end of the follow-up period among patients treated for palliation 15 died with a median survival rate of 163 days (range 13 days-309 days) and seven were alive. Conclusions: The new Wallflex colonic stent can be used effectively to manage patients presenting with large bowel obstruction. The use of stents as a ‘‘bridge to the elective surgery’’ allowed the intestinal preparation, general status restoration, and a one-stage operation with resection and primary reanastomosis.
T1530 Elective Cushion of the Submucosal Layer By Water Jet - Potential Advantage for Endoscopic Mucosal Resection Georg F. Kaehler, Moritz G. Sold, Stefan Post Introduction: Numerous new techniques for endoscopic mucosal resection (EMR) have been published in the recent years to enable endoscopists to treat large flat lesions of the GI tract. While some authors compared different substances for submucosal injection, others developed new cutting devices. The water jet is well established as an instrument for the dissection of parenchymatous organs due to its tissue selectivity. We report about the experimental use of a water jet in order to create submucosal cushions to prepare the mucosa for EMR. Aims & Methods: The effectiveness of creating submucosal cushions is tested by a direct application of the water jet to the mucosa. First we determined the pressure necessary to establish a submucosal fluid cushion [SFC] using saline solution in isolated stomachs of domestic pigs. Then we checked the influence of the angle of application between applicator and mucous membrane. Based on these findings, we generated 75 SFC’s in different parts of the stomach and quantified the size of the cushions by a special software programme. To verify these results the investigations were repeated in vivo in a pig model. Results: SFC’s of the gastric wall were created regularly with a pressure between 30 to 70 bar. The necessary pressure varied according to the spot of application. The angle of application had no effect on the formation of the SFC’s. After the first 10 seconds of applying the fluid the cushions seemed saturated and did not show a major change in size. The ex vivo results could be confirmed in a living pig model. Conclusion: The possibility of using a precisely focused water jet to penetrate the mucosa and to selectively create fluid cushions into the submucosa facilitates the endoscopic mucosal resection and is a promising alternative of the standard needle injection. The water jet application is potentially more efficient and could therefore help to develop a new minimal invasive therapy of mucosal tumors which could not be treated endoscopically so far for reasons of size, extension and position.
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB283
T1527 Efficacy and Safety of Self Expanding Metal Stent (SEMS) in Patients with Malignant Upper Gastrointestinal Obstruction and Associated Factors with Stent Patency Joing Pil IM, Jung Mook Kang, Soo-Jeong Cho, Byong Duk Ye, Sang Gyun Kim, Joo Sung Kim, Hyun Chae Jung, in Sung Song Background/Aims: Malignant upper gastrointestinal (GI) obstruction caused by advanced or inoperable neoplasm seriously impairs the quality of the patient’s life. Self expanding metal stent (SEMS) has known to be an effective and safe device for palliation of malignant esophageal, esophagogastric junction (EGJ), and gastric outlet (GO) obstruction. However, few studies have reported the long-term primary stent patency and the associated factors. The aims of this study were to evaluate the clinical outcomes including technical and clinical success rate and the associated factors with stent patency. Patients and Methods: A total of 77 consecutive patients who underwent endoscopic SEMS (MI techÒ, Seoul, Korea) placement to alleviate upper GI obstruction with unresectable malignancy were retrospectively reviewed in Seoul National University Hospital between April 2005 and August 2006. Clinical outcomes, complications and patency rate were assessed according to the site of obstruction and the stent type. Results: A total of 77 patients (66 men, mean age 62.1 years, range 37-84) underwent 105 SEMS placements. The site of obstruction was esophagus in 25 patients, EGJ in 15 and GO in 37, respectively. Patients with esophageal and EGJ obstruction were treated with covered stent (CS) and CS with anti-reflux valve, respectively. Twenty patients (54.1%) with GO obstruction were treated with CS. Technical success was achieved in 99% (104/105) and clinical success in 87.5% (91/104). The median stent patency time was 186.4 days with a mean follow up for 114.5 days (range 3-428 d) for 75 patients. Primary stent patency rates of esophagus and EGJ were 95.7%, 79.5%, and 66.3% at 30-, 90-, and 180-day, respectively, and were significantly higher than 80.1%, 56.6%, and 36.4% of GO (p Z 0.008). Re-obstruction by tumor overgrowth or ingrowth developed in 20.6% and was higher in GO than in esophagus or EGJ (27.3% vs. 12.8%, p Z 0.07). In patients with GO obstruction, overgrowth occurred more frequently with CS than with uncovered stents (33.3% vs. 9.7%, p Z 0.04). Migration of the stent occurred in 7.8% and was not significantly different in relation to site of obstruction and stent type. The majority of patients with reobstruction or migration were managed by placement of another SEMS (96.6%). There was no perforation, significant bleeding or procedure-related mortality. Conclusions: Endoscopic SEMS placement is an effective and safe palliative treatment for malignant upper GI obstruction and the stent patency is different in relation to site of obstruction and stent type.
T1528 Comparative Performance of Submucosal Fluid Injection with Hydroxypropyl Metylcellulose 0.25%, Carboxymethylcellulose 0.5% and Normal Saline Solution in a Porcine Model Luciano Lenz, Veruska Di Sena, Fernanda Thuler, Rodrigo Azevedo, Marcus Dos Santos, Frank Nakao, Gustavo De Paulo, Ermelindo Libera, Maria Rachel Rohr, Angelo P. Ferrari Background: Endoscopic mucosal resection (EMR) is an established modality for excision of sessile lesions in the gastrointestinal tract. Injection of fluid into the submucosa creates a submucosal fluid cushion and protects from thermal injury and the risk for perforation. This blinded study investigated the performance of three different solutions to create submucosal fluid cushions in a porcine stomach. Methods: Nine minipigs BR1 were studied in this blinded study. Injected solutions were: normal saline solution (NSS), carboxymethylcellulose 0.5% (CMC) and hydroxypropyl methylcellulose 0.25% (HPMC). In each pig, three 6 ml submucosal injections of each solution were used with one drop of methylene blue for better visualization. The time for the bleb to disappear was recorded. Results: The overall median time submucosal for fluid cushion was 37 minutes (range 12-60) for HPMC, 31 minutes for CMC (range 10-43) and 19 minutes for NSS (range 8-37). There was no significant difference in NSS and CMC (p Z 0,146) and either between CMC and HPMC (p Z 0,119) but the median duration of HPMC was significantly longer than NSS (p Z 0,039). Conclusions: The length of HPMC submucosal fluid cushion is longer in comparison with NSS. The median time for CMC was not significantly longer than NSS. HPMC in the concentration of 0.25% may be an inexpensive and available alternative for submucosal injections.
www.giejournal.org
T1529 Treatment of Acute Malignant Colorectal Obstruction with WallflexTM Colonic Stents: A Prospective Study Giuseppe De Caro, Alessandro Repici, Salvatore Comunale, Vincenzo Cennamo, Carlo Fabbri, Paoletta Preatoni, Nico Pagano, Cristina M. Hervoso, Silvio Danese, Carmelo Luigiano, Tommaso Stefanelli, Alberto Malesci Background: Colonic stenting may serve as a bridge to surgery. Alternatively, in patients who are not candidates for surgery, colonic stenting may be performed for palliation. The aim of this prospective study was to evaluate the efficacy and safety of the new WallflexTM colonic stents for acute bowel obstruction due to primary or recurrent colonic adenocarcinoma. Methods: from May 2004 to September 2006, patients with malignant large bowel occlusion were included in the study. Study was approved by the EC and patients gave informed consent. Exclusion criteria consisted of: benign stricture; perforated colon; extrinsic compressive tumor; concurrent radiotherapy for the colorectal stricture or treatment with an investigational drug or device within the preceding 4 weeks; placement of another metal stent for the same stricture. The presence of large bowel obstruction was confirmed by erect and supine abdominal X-rays and CT scan. Results: SEMS insertion was performed in 40 consecutive patients (17 females, 23 males, mean age 72.2 years with a range of 53 to 92 years). Technical and clinical success was obtained in 36 of 40 patients (92,5%). Failures were due to: stent misplacement; no expansion of the stent; impossibility to pass through the stricture. The distribution of malignant stenosis was as follows: rectum (n Z 7, 17.5%), sigmoid colon (n Z 18, 45%), descending colon (n Z 9, 22.5%), splenic flexure (n Z 2, 5%), transverse colon (n Z 2, 5%) and hepatic flexure (n Z 2, 5%). Colonic stenting was performed as bridge to surgery in 18 patients (45%) and as palliative treatment in 22 patients (55%). Early complications (within 1 week after SEMS placement) occurred in 2 patients: one colon perforation and one stent occlusion for stool impaction. Long-term complications occurred in 6 patients: 1 stent occlusion for fecal impaction, 2 for tumor ingrowth and 1 for tumor overgrowth and 1 rectal bleeding. The mean time between stent placement and surgery was 5.2 days (range, 2-12). There were not surgery complications. At the end of the follow-up period among patients treated for palliation 15 died with a median survival rate of 163 days (range 13 days-309 days) and seven were alive. Conclusions: The new Wallflex colonic stent can be used effectively to manage patients presenting with large bowel obstruction. The use of stents as a ‘‘bridge to the elective surgery’’ allowed the intestinal preparation, general status restoration, and a one-stage operation with resection and primary reanastomosis.
T1530 Elective Cushion of the Submucosal Layer By Water Jet - Potential Advantage for Endoscopic Mucosal Resection Georg F. Kaehler, Moritz G. Sold, Stefan Post Introduction: Numerous new techniques for endoscopic mucosal resection (EMR) have been published in the recent years to enable endoscopists to treat large flat lesions of the GI tract. While some authors compared different substances for submucosal injection, others developed new cutting devices. The water jet is well established as an instrument for the dissection of parenchymatous organs due to its tissue selectivity. We report about the experimental use of a water jet in order to create submucosal cushions to prepare the mucosa for EMR. Aims & Methods: The effectiveness of creating submucosal cushions is tested by a direct application of the water jet to the mucosa. First we determined the pressure necessary to establish a submucosal fluid cushion [SFC] using saline solution in isolated stomachs of domestic pigs. Then we checked the influence of the angle of application between applicator and mucous membrane. Based on these findings, we generated 75 SFC’s in different parts of the stomach and quantified the size of the cushions by a special software programme. To verify these results the investigations were repeated in vivo in a pig model. Results: SFC’s of the gastric wall were created regularly with a pressure between 30 to 70 bar. The necessary pressure varied according to the spot of application. The angle of application had no effect on the formation of the SFC’s. After the first 10 seconds of applying the fluid the cushions seemed saturated and did not show a major change in size. The ex vivo results could be confirmed in a living pig model. Conclusion: The possibility of using a precisely focused water jet to penetrate the mucosa and to selectively create fluid cushions into the submucosa facilitates the endoscopic mucosal resection and is a promising alternative of the standard needle injection. The water jet application is potentially more efficient and could therefore help to develop a new minimal invasive therapy of mucosal tumors which could not be treated endoscopically so far for reasons of size, extension and position.
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB283