- Email: [email protected]
IT-ESD Is Useful Technique for the Elderly Patients with Gastric Cancer
Abstracts
T1494 Self Expending Metallic Stents (SEMS) with Antireflux Valve for Distal Esophageal Carcinoma: Results of a Randomized Trial Marc Le Rhun, Emmanuel Ben Soussan, Emmanuel Coron, Anne Le Sidaner, Thierry Barrioz, Dimitri Coumaros, Jean-Michel Nguyen, Bertrand Vedrenne, Philippe Bichard, Christian Boustiere, Frederic Prat D’Endoscopie Digestive Societe Francaise Aims: SEMS are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were 1) to assess the influence of the antireflux valve on trans-prothetic reflux (primary outcome) and 2) to compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and complications (secondary outcomes). Patients and Methods: Thirty eight patients (age 71 G 12 years ; sex ratio 5) with malignant strictures of the distal esophagus or gastric cardia (53% adenocarcinomas) were enrolled in 9 centers. Carcinomas were locally advanced (47%) or generalized. After randomization, patients received either a covered SEMS without antireflux valve (CHOOSTENTÒ, Life Europe) associated to standard PPI therapy and postural advice (n Z 19) or a similar type of SEMS including an antireflux device (DOSTENTÒ, Life Europe) (n Z 19). Trans-prosthetic reflux was assessed at day 2 using a radiological score based on barium esophagography performed after Trendelenburg maneuver and graded from 0 (no reflux) to 12 (maximum). Monthly telephone interviews were conducted for: a) OMS scoring from 0 (excellent) to 5 (poor) b) QOL assessment (based on the Reflux-Qual Simplifie´ scoring system) from 0 (poor) to 100 (excellent) c) dysphagia scoring from 0 (no dysphagia) to 5 (complete dysphagia) and d) regurgitation scoring from 0 (no regurgitation) to 16 (maximum). Results :No difference was noted in terms of age, sex, size of lesion, prosthesis length (12 G 2.5 cm) and need for dilation (30%) prior to SEMS placement. No difficulty to place SEMS nor complication were noted. QOL and dysphagia were improved in both groups. Mean survival was similar in both groups (180 days). Results according to the type of SEMS were as follows: (table 1) Conclusions: These two types of SEMS are equally effective on the palliation of dysphagia and improvement of QOL. However, SEMS with antireflux valve are more efficient to prevent trans-prosthetic gastroesophageal reflux but at the cost of an increased likehood of migrations.
Scores Radiological reflux Regurgitation at 1 month OMS stage at 1 month Dysphagia at 1 month Quality of life at 1 month Prosthesis migration
SEMS without antireflux valve(n Z 19) 4.8 6.5 1.7 0.7 56
G G G G G 1
3.4 5.3 1.4 0.8 21
SEMS with antireflux valve (n Z 19)
p
0.06 G 0.2 1.4 G 3.7 1.6 G 1.0 0.6 G 0.9 62 G 23 4
! 0.0001 0.008 NS NS NS NS
T1495 IT-ESD Is Useful Technique for the Elderly Patients with Gastric Cancer Masahito Nomoto, Yoshiyuki Watanabe, Mami Iwashige, Ryujiro Negishi, Mika Kobayashi, Minako Kobayashi, Tadateru Maehata, Masaru Okamoto, Santa Hattori, Naoyuki Kato, Satoshi Baba, Yasushi Adachi, Yasuo Kato, Hirofumi Niwa, Fumio Itoh Background: Minimally invasive treatments, such as endoscopic mucosal resection (EMR), are now performed as usual clinical practice in Japan. Moreover, the introduction of various new devices, such as the insulation-tipped electrosurgical knife (IT-Knife), has expanded the indication of EMR for the treatment of earlystage gastric carcinoma, and it is called as endoscopic submucosal dissection using an IT-knife (IT-ESD). IT-ESD makes EMR possible to remove more wide lesion and en bloc resection. However, the safety of this strategy has not validated completely, particularly for elderly patients. In order to assess the availability and safety, especially for the elderly patients with gastric carcinoma, we evaluated efficacy of our expanded criteria compare to the standard criteria, and analyzed our results of IT-ESD retrospectively. Materials & Methods: All patients were undergoing for mucosal gastric carcinoma treated with IT-ESD in our expanded criteria. Our expanded criteria is 1. Mucosal invasive lesion, 2. Adenoma with severe atypia and differentiated carcinoma, 3. No ulceration, 4. Without limitation of tumor size. We retrospectively reviewed the records of 184 patients admitted to St. Marianna University School of Medicine Hospital with our criteria between April 2002 and
www.giejournal.org
November 2005. We analyzed our data in several factors, including resection rate, en bloc resection rate, recurrent rage, age, and background characteristics of the patients. We also assessed our expanded criteria compared to the standard one. Results: The number of 154 cases out of 184 (83.7%) were completely removed and 164 cases (87.0%) were en bloc resected with IT-ESD. Two cases were diagnosed to be recurrence by follow up endoscopic biopsy. One case was retried by IT-ESD and another was treated by laparoscopic gastrectomy. Complications, such as post operative bleeding and minimal perforation, occurred in 6%. IT-ESD could remove large lesions (over 20 mm) compare to the traditional EMR apparently. This cohort contained 119 cases (64.7%) of elderly (over 65 years old). There was no significant difference in resection rate and complication between elderly and others. Conclusion: IT-ESD might be safe and useful for treatment of larger tumor than the standard criteria. Moreover, IT-ESD may be useful technique for the elderly patients with gastric cancer.
T1496 Endoscopic Transmural Resection of Gastric Wall Using Full-Thickness Plication Ram Chuttani, Douglas Pleskow, Laura Ornellas Background: Endoscopic mucosal resection allows for removal of premalignant mucosal lesions. Currently, lesions invading into the submucosa and muscularis propria require surgical resection.Aim: To develop and evaluate an endoscopic technique to allow transmural resection of the gastric wall using the Full-Thickness Plicator (NDO Surgical, Mansfield, MA) in the porcine stomach model. The Plicator deploys a transmural pre-tied polypropylene suture with two ePTFE suture pledgets. Methods: A modified Plicator cartridge was created with suture length of 4 mm (50% shorter than standard) between the pledgets. Five excised porcine stomachs were used in the experiments. The Plicator was inserted into the stomach and the tissue retractor was extended into targeted gastric wall; the gastric wall was retracted into the open arms of the Plicator and a full-thickness plication was created to promote serosa to serosa tissue apposition. A stiff snare was used to resect the plicated gastric wall above the suture/ePTFE implant using electrocautery. The serosa to serosa tissue union was left intact. The excised wall was examined to ensure a full-thickness resection and the size was measured. The integrity of the plication was tested by instilling a colored, carbonated liquid to distend the stomach. Results: A transmural, full-thickness gastric wall resection was achieved in all 5 porcine stomachs. The diameter of the excised specimen ranged from 2 to 3 cm. The gastric wall was securely closed with no leaks observed after the full-thickness resection was performed. Conclusions: 1. Endoscopic transmural resection of gastric wall is possible by first performing full-thickness plication. 2. Following resection, no perforation of the gastric wall was evident and no leaks were observed. 3. This technique could become an endoscopic alternative to surgery for early gastric malignancies.
T1497 The Usefulness of an Insulated Tip-Knife for Endoscopic Treatment of Postoperative Esophageal Stenosis Chang Beom Ryu, Jae Hwa Jung, Sang Gyune Kim, in Sup Jung, Bong Min Ko, Su Jin Hong, Young Seok Kim, Jong Ho Moon, Joo Young Cho, Joon Seong Lee, Moon Sung Lee, Chan Sup Shim, Boo Sung Kim Background: Although benign esophageal stenosis following surgical resection can be treated by using balloon dilator, bougie or microwave, a sustained response is difficult to achieve because of restenosis or poor acceptance by patients. The study examined the effectiveness and usefulness of insulated tip-knife for the endoscopic treatment of postoperative anastomotic esophageal stenosis. Methods: Endoscopic incision using IT-knife in four directions of the stricture site under the endocut mode was performed with eight patients (4:4 (male:female); 48.6 yrs (mean age)) with esophageal stenosis who underwent esophagojejunostomy (six patients) or esophagogastrostomy (two patients). While patient’s ability to swallow was graded according to the five-point dysphagia scale, the degree of stricture was classified by the extent of endoscopic penetration, and further the frequency of treatments was comparatively studied. Results: Endoscopic incision using IT-knife was successful in all patients whose dysphagia score showed lower. The mean baseline dysphagia score was 2.4, but declined to 1.1 after the dilation. The degree of stricture improved in all patients, revealing no procedure-related complication resulted. The mean frequency of treatments was 1.3 (ranging 1-3), and endoscopy showed no recurrence of stenosis but one patient died of cancer recurrence during the mean follow-up period of 11.5 months (ranging 5-22 months). Conclusion: Using IT-knife is effective to dilate the stricture without complications and to sustain the response. Therefore, the results suggest that an IT-knife be useful for endoscopic treatment of postoperative esophageal stenosis.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB241
T1494 Self Expending Metallic Stents (SEMS) with Antireflux Valve for Distal Esophageal Carcinoma: Results of a Randomized Trial Marc Le Rhun, Emmanuel Ben Soussan, Emmanuel Coron, Anne Le Sidaner, Thierry Barrioz, Dimitri Coumaros, Jean-Michel Nguyen, Bertrand Vedrenne, Philippe Bichard, Christian Boustiere, Frederic Prat D’Endoscopie Digestive Societe Francaise Aims: SEMS are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were 1) to assess the influence of the antireflux valve on trans-prothetic reflux (primary outcome) and 2) to compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and complications (secondary outcomes). Patients and Methods: Thirty eight patients (age 71 G 12 years ; sex ratio 5) with malignant strictures of the distal esophagus or gastric cardia (53% adenocarcinomas) were enrolled in 9 centers. Carcinomas were locally advanced (47%) or generalized. After randomization, patients received either a covered SEMS without antireflux valve (CHOOSTENTÒ, Life Europe) associated to standard PPI therapy and postural advice (n Z 19) or a similar type of SEMS including an antireflux device (DOSTENTÒ, Life Europe) (n Z 19). Trans-prosthetic reflux was assessed at day 2 using a radiological score based on barium esophagography performed after Trendelenburg maneuver and graded from 0 (no reflux) to 12 (maximum). Monthly telephone interviews were conducted for: a) OMS scoring from 0 (excellent) to 5 (poor) b) QOL assessment (based on the Reflux-Qual Simplifie´ scoring system) from 0 (poor) to 100 (excellent) c) dysphagia scoring from 0 (no dysphagia) to 5 (complete dysphagia) and d) regurgitation scoring from 0 (no regurgitation) to 16 (maximum). Results :No difference was noted in terms of age, sex, size of lesion, prosthesis length (12 G 2.5 cm) and need for dilation (30%) prior to SEMS placement. No difficulty to place SEMS nor complication were noted. QOL and dysphagia were improved in both groups. Mean survival was similar in both groups (180 days). Results according to the type of SEMS were as follows: (table 1) Conclusions: These two types of SEMS are equally effective on the palliation of dysphagia and improvement of QOL. However, SEMS with antireflux valve are more efficient to prevent trans-prosthetic gastroesophageal reflux but at the cost of an increased likehood of migrations.
Scores Radiological reflux Regurgitation at 1 month OMS stage at 1 month Dysphagia at 1 month Quality of life at 1 month Prosthesis migration
SEMS without antireflux valve(n Z 19) 4.8 6.5 1.7 0.7 56
G G G G G 1
3.4 5.3 1.4 0.8 21
SEMS with antireflux valve (n Z 19)
p
0.06 G 0.2 1.4 G 3.7 1.6 G 1.0 0.6 G 0.9 62 G 23 4
! 0.0001 0.008 NS NS NS NS
T1495 IT-ESD Is Useful Technique for the Elderly Patients with Gastric Cancer Masahito Nomoto, Yoshiyuki Watanabe, Mami Iwashige, Ryujiro Negishi, Mika Kobayashi, Minako Kobayashi, Tadateru Maehata, Masaru Okamoto, Santa Hattori, Naoyuki Kato, Satoshi Baba, Yasushi Adachi, Yasuo Kato, Hirofumi Niwa, Fumio Itoh Background: Minimally invasive treatments, such as endoscopic mucosal resection (EMR), are now performed as usual clinical practice in Japan. Moreover, the introduction of various new devices, such as the insulation-tipped electrosurgical knife (IT-Knife), has expanded the indication of EMR for the treatment of earlystage gastric carcinoma, and it is called as endoscopic submucosal dissection using an IT-knife (IT-ESD). IT-ESD makes EMR possible to remove more wide lesion and en bloc resection. However, the safety of this strategy has not validated completely, particularly for elderly patients. In order to assess the availability and safety, especially for the elderly patients with gastric carcinoma, we evaluated efficacy of our expanded criteria compare to the standard criteria, and analyzed our results of IT-ESD retrospectively. Materials & Methods: All patients were undergoing for mucosal gastric carcinoma treated with IT-ESD in our expanded criteria. Our expanded criteria is 1. Mucosal invasive lesion, 2. Adenoma with severe atypia and differentiated carcinoma, 3. No ulceration, 4. Without limitation of tumor size. We retrospectively reviewed the records of 184 patients admitted to St. Marianna University School of Medicine Hospital with our criteria between April 2002 and
www.giejournal.org
November 2005. We analyzed our data in several factors, including resection rate, en bloc resection rate, recurrent rage, age, and background characteristics of the patients. We also assessed our expanded criteria compared to the standard one. Results: The number of 154 cases out of 184 (83.7%) were completely removed and 164 cases (87.0%) were en bloc resected with IT-ESD. Two cases were diagnosed to be recurrence by follow up endoscopic biopsy. One case was retried by IT-ESD and another was treated by laparoscopic gastrectomy. Complications, such as post operative bleeding and minimal perforation, occurred in 6%. IT-ESD could remove large lesions (over 20 mm) compare to the traditional EMR apparently. This cohort contained 119 cases (64.7%) of elderly (over 65 years old). There was no significant difference in resection rate and complication between elderly and others. Conclusion: IT-ESD might be safe and useful for treatment of larger tumor than the standard criteria. Moreover, IT-ESD may be useful technique for the elderly patients with gastric cancer.
T1496 Endoscopic Transmural Resection of Gastric Wall Using Full-Thickness Plication Ram Chuttani, Douglas Pleskow, Laura Ornellas Background: Endoscopic mucosal resection allows for removal of premalignant mucosal lesions. Currently, lesions invading into the submucosa and muscularis propria require surgical resection.Aim: To develop and evaluate an endoscopic technique to allow transmural resection of the gastric wall using the Full-Thickness Plicator (NDO Surgical, Mansfield, MA) in the porcine stomach model. The Plicator deploys a transmural pre-tied polypropylene suture with two ePTFE suture pledgets. Methods: A modified Plicator cartridge was created with suture length of 4 mm (50% shorter than standard) between the pledgets. Five excised porcine stomachs were used in the experiments. The Plicator was inserted into the stomach and the tissue retractor was extended into targeted gastric wall; the gastric wall was retracted into the open arms of the Plicator and a full-thickness plication was created to promote serosa to serosa tissue apposition. A stiff snare was used to resect the plicated gastric wall above the suture/ePTFE implant using electrocautery. The serosa to serosa tissue union was left intact. The excised wall was examined to ensure a full-thickness resection and the size was measured. The integrity of the plication was tested by instilling a colored, carbonated liquid to distend the stomach. Results: A transmural, full-thickness gastric wall resection was achieved in all 5 porcine stomachs. The diameter of the excised specimen ranged from 2 to 3 cm. The gastric wall was securely closed with no leaks observed after the full-thickness resection was performed. Conclusions: 1. Endoscopic transmural resection of gastric wall is possible by first performing full-thickness plication. 2. Following resection, no perforation of the gastric wall was evident and no leaks were observed. 3. This technique could become an endoscopic alternative to surgery for early gastric malignancies.
T1497 The Usefulness of an Insulated Tip-Knife for Endoscopic Treatment of Postoperative Esophageal Stenosis Chang Beom Ryu, Jae Hwa Jung, Sang Gyune Kim, in Sup Jung, Bong Min Ko, Su Jin Hong, Young Seok Kim, Jong Ho Moon, Joo Young Cho, Joon Seong Lee, Moon Sung Lee, Chan Sup Shim, Boo Sung Kim Background: Although benign esophageal stenosis following surgical resection can be treated by using balloon dilator, bougie or microwave, a sustained response is difficult to achieve because of restenosis or poor acceptance by patients. The study examined the effectiveness and usefulness of insulated tip-knife for the endoscopic treatment of postoperative anastomotic esophageal stenosis. Methods: Endoscopic incision using IT-knife in four directions of the stricture site under the endocut mode was performed with eight patients (4:4 (male:female); 48.6 yrs (mean age)) with esophageal stenosis who underwent esophagojejunostomy (six patients) or esophagogastrostomy (two patients). While patient’s ability to swallow was graded according to the five-point dysphagia scale, the degree of stricture was classified by the extent of endoscopic penetration, and further the frequency of treatments was comparatively studied. Results: Endoscopic incision using IT-knife was successful in all patients whose dysphagia score showed lower. The mean baseline dysphagia score was 2.4, but declined to 1.1 after the dilation. The degree of stricture improved in all patients, revealing no procedure-related complication resulted. The mean frequency of treatments was 1.3 (ranging 1-3), and endoscopy showed no recurrence of stenosis but one patient died of cancer recurrence during the mean follow-up period of 11.5 months (ranging 5-22 months). Conclusion: Using IT-knife is effective to dilate the stricture without complications and to sustain the response. Therefore, the results suggest that an IT-knife be useful for endoscopic treatment of postoperative esophageal stenosis.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB241