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Palliation of Patients with Malignant Gastric Outlet Obstruction with the WallFlex Enteral Stent: A Retrospective Multicentre Study
Abstracts
T1510 A Novel External Lead Sensor Array Placement Approach for Capsule Endoscopy Gary Chen, Oren Goltzer, Jason Shen, Christopher Chang, Shahab Mehdizadeh, James Sul, Rome Jutabha
T1512 Outcome of Endoscopic Management of Complete Cervical Esophageal Obstruction Jennifer Kaufman, Mark Schattner, Richard Wong, Nancy Lee, Jay Boyle, Hans Gerdes, Moshe Shike, Dennis Kraus
Background: Capsule endoscopy (CE) of the small bowel (SB) & esophagus (ESO) requires placement of 8 lead sensor array over the abdomen that receives image and localization data transmitted from the capsule. This current process of applying lead sensor array to the skin has disadvantages: 1) it is time consuming, and 2) it can be uncomfortable to the patient. We hypothesized that a new external sensor array system could adequately receive transmitted images during CE without significant data loss and have equivalent diagnostic yield with standard skin leads. Methods: We tested this new device on 13 patients from 8/2005-11/2005. 8 patients underwent esophageal CE for GERD and 5 had small bowel CE for OGIB. All 13 patients had 2 sets of sensor arrays, batteries, and data recorders placed concurrently. The standard array was placed on the skin surface of the chest or abdomen in the usual manner (control) while the external array was pre-positioned on a gown that was worn over the skin leads. The total number of captured versus dropped images recorded by the skin and external lead systems were compared visually and then analyzed statistically. Results: 8/8 GERD patients had grade 1-2 reflux esophagitis on CE ESO. 4/5 OGIB patients had small bowel AVM’s while 1 patient had a small bowel carcinoid tumor on CE SB. The same final diagnoses were made on all 13 patients by both standard and novel external lead methods. For the 13 patients, a total of 313793 images were detected on CE procedures with the standard method while 311169 images were detected with the novel external method (99.2% of the control). All of the non-captured images missed by the external array leads occurred in short segments (4-5 frame segments); no prolonged stretches of missing data occurred with either method. The quality of captured CE images was identical between the 2 methods, but CE localization tracings were different, presumably related to movement of the leads during the recording period. Most of the patients preferred the novel external method because of less skin irritation and discomfort during the lead removal process, as well as shorter setup time without the need of removing clothing. Conclusion: 1) A pre-positioned external lead sensor array can achieve CE data without clinically significant loss of image quality and diagnostic yield, 2) localization tracings for CE SB are different due to movement of the external array, 3) more patients preferred the novel external method than the standard method. These preliminary results must be confirmed with larger sample size.
Background: Larynx preserving treatment of head and neck cancer has evolved to include a combination of chemotherapy and radiation therapy. As a result of anticipated treatment-induced dysphagia/odynophagia, patients have a gastrostomy tube (PEG) placed for enteral nutrition. Esophageal stricture is a well described complication of radiation therapy, but complete obstruction is uncommon and difficult to treat by standard endoscopic approaches. We are reporting on our experience of using endoscopic techniques to relieve complete radiation-induced pharyngoesophageal obstruction in head and neck cancer patients. Methods: A retrospective review was conducted of all head and neck cancer patients with complete radiation-induced pharyngoesophageal obstruction between January 2004 and August 2005. Fifteen patients were identified as appropriate candidates for an attempt at an endoscopic ‘‘rendezvous procedure’’ which combines anterograde laryngoscopy via the mouth and retrograde endoscopy via the gastrostomy fistula. The subsequent reestablishment of luminal continuity is achieved by controlled perforation of the transilluminated obstructed area with a guidewire under direct visualization followed by savory dilation. Results: The procedure was attempted in 11 male and 4 female patients with an average age of 66 years (range: 45-82). Time from completion of radiation to diagnosis of complete obstruction was 6.8 months (range: 1-15). The average stricture length was 2.4 cm (range: 1 to 6). Success in establishing luminal patency was achieved in 13 patients (87%). Two patients were felt to have strictures too long to achieve technical success. Response to the procedure was defined as complete (able to tolerate a regular diet and have PEG removed), partial (able to tolerate a liquid or pureed diet), or poor (PEG-dependent and taking nothing by mouth). Of the 15 patients, five had a complete response, 6 had a partial response and 4 had a poor response. The average number of post-‘‘rendezvous’’ dilations was 4.6 (range: 1-12). Two complications (1 pneumomediastinum and 1 laryngeal edema) occurred. Both were managed conservatively. There was no procedure related mortality. Conclusion: Combined anterograde-retrograde esophageal dilation is an effective and safe method for reestablishing luminal patency in patients with radiationinduced complete pharyngoesophageal obstruction, allowing for the resumption of oral intake in the majority of patients and alleviating the need for PEG tube dependence in some.
T1511 Endoscopic Balloon Dilation of Stomal Stenosis Following Gastric Bypass Surgery Marc F. Catalano, Thomas Y. Chua, Oscar a. Batista, Goran T. Rudic Obesity has reached epidemic proportions in the US with significant impact on pt health. Many therapies have been unsuccessful. Surgery appears to be the only effective long-term solution. Roux-en-Y bypass (RYGB), takes advantage of both restrictive (small pouch) & malabsorptive technique (bypass). An occasional problem with restrictive procedures is postoperative stenosis of the gastric outlet (stoma) causing variable obstructive symptoms. Methods: Over 4-yrs, 29 RYGB pts with symptoms of gastric outlet obstruction presented for endotherapy. 23 F/6 M, age 28-45 (mean 37.5). Pt presentation: rapid wt loss (24), N/V (28), dehydration (5), & dysphagia (2). Pts presented 1-18 mo following RYGB (mean 4). All procedures were done with standard upper scope under fluoro. Dilation was performed using graduated CRE balloons (8-10, 10-12, 12-15) to maximum diameter (8 atm), 60 sec intervals. One CRE balloon sz range was used per endo session. Following dilation, the stoma was injected with a steroid solution (Kenalog 40 mg, mixture 1:4), 1 cc/ quadrant, circumferentially. Results: All underwent successful balloon dil. Dilating sessions ranged from 1-7 (mean 2.4) at 2-wk intervals. This included 8 pts-one dil, 10 pts-two dil, 7 pts-3 dil, 3 pts-4 dil, 1 pt-7 dil. Those pts requiring repeat dil (21) underwent repeat maximum dil with 8-10 CRE (4), 10-12 CRE (11), & 12-15 CRE (7). Need for repeat dil was determined by persistence of initial symptoms, & stoma sz !10 mm at F/U. Estimated stoma diameter prior to dil was 1-8 mm (mean 3.5). None could be traversed with standard scope. Following dil, diameter of stoma increased to 10-15 mm (mean 12.5). Of pts who required a single dil (8), pre dil stoma sz was a mean of 5.6 mm (range 3-8), which increased to a mean of 12.7 mm (range 10-15). Those requiring multiple dil (21), pre dil stoma sz was a mean of 2.6 mm (range 1-4), which increased to a mean of 12.1 mm (range 10-14). 28 of 29 pts had good long-term response at 6-38 mo. One pt with concomitant large stomal ulcer required surgical revision following 7 dil sessions. All pts had resumption of wt loss expected for RYGB following successful endotherapy. Conclusions: Stomal stenosis following RYGB is a common post surgical complication. Endoscopic balloon dil is an effective, nonsurgical option in the treatment of stomal stenosis with no complications observed in this, the largest reported series. Stoma Diameter-mm(mean) Frequency of Dilation Single Multiple Total
www.giejournal.org
Pt (n)
Pre Dilation (mean)
Post Dilation (mean)
8 21 29
5.6 2.6 3.5
12.7 12.1 12.2
T1513 Palliation of Patients with Malignant Gastric Outlet Obstruction with the WallFlex Enteral Stent: A Retrospective Multicentre Study Jeanin Van Hooft, Massimiliano Mutignani, Alessandro Repici, Helmut Messmann, Horst Neuhaus, Paul Fockens Introduction: Gastric outlet obstruction can be a late complication of advanced gastric, periampullary and duodenal carcinoma. Palliation of symptoms of obstruction is the primary aim of treatment in these patients. Self-expandable metal stents (SEMS) have emerged as a promising treatment option. The purpose of this study was to investigate the technical and short-term clinical success (30 days) of a new enteral stent made of nitinol (WallFlex, Boston Scientific) in a multicentre patient cohort. Methods: The first 18 European centres having this stent were approached to collect data of every patient treated. Of these centres 15 returned their data. The collected data were: general patients’ data, type of tumour, complaints, symptom-score (Gastric-Outlet-Obstruction-Scoring-System: a 4-point scoring system from 0 to 3) before and one week after stent placement, procedure related technical data and complications within 30 days. Descriptive statistics were used and the patients’ improvement of GOOSS-score by two points was calculated using the Chi-square test. A GOOSS-score of 2 and 3 was considered a satisfactory quality of diet. Results: Case record forms of 62 patients (35 men, mean age 70 years) were completed. Obstruction was caused by cancer of the stomach in 9, periampullary in 47, duodenal in 1 and metastases in 5. All patients suffered from nausea, vomiting or inability to eat. The median length of the stenosis was 4 cm (1-15 cm). Sixty-six enteral stents (diameter 27/22 mm) were placed: 58 patients required one stent, 4 patients required two stents either because of the position (2) or the length of the stenosis (1) or due to migration (1). Before stent placement 49 patients had no oral intake or were only tolerating liquids (GOOSS-score 0 or 1). The GOOSS-score after one week was obtained from 56 patients (6 patients died): of these 7 were able to tolerate liquids only and 49 patients tolerated soft solids or a low-residue diet (GOOSS-score 2 or 3). A GOOSS-score improved by two points was significant (p Z 0.007). Oral intake was possible on average 1 day (0-8 days) after stent placement. Of the 62 patients enrolled the 30 days follow-up has so far been collected in 59. Complications within 30 days occurred in 11 patients: perforation (2), stent migration (2), tumour ingrowth (1), bleeding (1), aspiration pneumonia (3), cholangitis (1), sepsis of unknown origin (1). Conclusion: WallFlex enteral stent placement for the palliative treatment of patients with malignant gastric outlet obstruction was technical successful in 58 out of 62 (94%) and allowed 49 out of 62 (79%) patients to resume a satisfactory quality of diet.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB245
T1510 A Novel External Lead Sensor Array Placement Approach for Capsule Endoscopy Gary Chen, Oren Goltzer, Jason Shen, Christopher Chang, Shahab Mehdizadeh, James Sul, Rome Jutabha
T1512 Outcome of Endoscopic Management of Complete Cervical Esophageal Obstruction Jennifer Kaufman, Mark Schattner, Richard Wong, Nancy Lee, Jay Boyle, Hans Gerdes, Moshe Shike, Dennis Kraus
Background: Capsule endoscopy (CE) of the small bowel (SB) & esophagus (ESO) requires placement of 8 lead sensor array over the abdomen that receives image and localization data transmitted from the capsule. This current process of applying lead sensor array to the skin has disadvantages: 1) it is time consuming, and 2) it can be uncomfortable to the patient. We hypothesized that a new external sensor array system could adequately receive transmitted images during CE without significant data loss and have equivalent diagnostic yield with standard skin leads. Methods: We tested this new device on 13 patients from 8/2005-11/2005. 8 patients underwent esophageal CE for GERD and 5 had small bowel CE for OGIB. All 13 patients had 2 sets of sensor arrays, batteries, and data recorders placed concurrently. The standard array was placed on the skin surface of the chest or abdomen in the usual manner (control) while the external array was pre-positioned on a gown that was worn over the skin leads. The total number of captured versus dropped images recorded by the skin and external lead systems were compared visually and then analyzed statistically. Results: 8/8 GERD patients had grade 1-2 reflux esophagitis on CE ESO. 4/5 OGIB patients had small bowel AVM’s while 1 patient had a small bowel carcinoid tumor on CE SB. The same final diagnoses were made on all 13 patients by both standard and novel external lead methods. For the 13 patients, a total of 313793 images were detected on CE procedures with the standard method while 311169 images were detected with the novel external method (99.2% of the control). All of the non-captured images missed by the external array leads occurred in short segments (4-5 frame segments); no prolonged stretches of missing data occurred with either method. The quality of captured CE images was identical between the 2 methods, but CE localization tracings were different, presumably related to movement of the leads during the recording period. Most of the patients preferred the novel external method because of less skin irritation and discomfort during the lead removal process, as well as shorter setup time without the need of removing clothing. Conclusion: 1) A pre-positioned external lead sensor array can achieve CE data without clinically significant loss of image quality and diagnostic yield, 2) localization tracings for CE SB are different due to movement of the external array, 3) more patients preferred the novel external method than the standard method. These preliminary results must be confirmed with larger sample size.
Background: Larynx preserving treatment of head and neck cancer has evolved to include a combination of chemotherapy and radiation therapy. As a result of anticipated treatment-induced dysphagia/odynophagia, patients have a gastrostomy tube (PEG) placed for enteral nutrition. Esophageal stricture is a well described complication of radiation therapy, but complete obstruction is uncommon and difficult to treat by standard endoscopic approaches. We are reporting on our experience of using endoscopic techniques to relieve complete radiation-induced pharyngoesophageal obstruction in head and neck cancer patients. Methods: A retrospective review was conducted of all head and neck cancer patients with complete radiation-induced pharyngoesophageal obstruction between January 2004 and August 2005. Fifteen patients were identified as appropriate candidates for an attempt at an endoscopic ‘‘rendezvous procedure’’ which combines anterograde laryngoscopy via the mouth and retrograde endoscopy via the gastrostomy fistula. The subsequent reestablishment of luminal continuity is achieved by controlled perforation of the transilluminated obstructed area with a guidewire under direct visualization followed by savory dilation. Results: The procedure was attempted in 11 male and 4 female patients with an average age of 66 years (range: 45-82). Time from completion of radiation to diagnosis of complete obstruction was 6.8 months (range: 1-15). The average stricture length was 2.4 cm (range: 1 to 6). Success in establishing luminal patency was achieved in 13 patients (87%). Two patients were felt to have strictures too long to achieve technical success. Response to the procedure was defined as complete (able to tolerate a regular diet and have PEG removed), partial (able to tolerate a liquid or pureed diet), or poor (PEG-dependent and taking nothing by mouth). Of the 15 patients, five had a complete response, 6 had a partial response and 4 had a poor response. The average number of post-‘‘rendezvous’’ dilations was 4.6 (range: 1-12). Two complications (1 pneumomediastinum and 1 laryngeal edema) occurred. Both were managed conservatively. There was no procedure related mortality. Conclusion: Combined anterograde-retrograde esophageal dilation is an effective and safe method for reestablishing luminal patency in patients with radiationinduced complete pharyngoesophageal obstruction, allowing for the resumption of oral intake in the majority of patients and alleviating the need for PEG tube dependence in some.
T1511 Endoscopic Balloon Dilation of Stomal Stenosis Following Gastric Bypass Surgery Marc F. Catalano, Thomas Y. Chua, Oscar a. Batista, Goran T. Rudic Obesity has reached epidemic proportions in the US with significant impact on pt health. Many therapies have been unsuccessful. Surgery appears to be the only effective long-term solution. Roux-en-Y bypass (RYGB), takes advantage of both restrictive (small pouch) & malabsorptive technique (bypass). An occasional problem with restrictive procedures is postoperative stenosis of the gastric outlet (stoma) causing variable obstructive symptoms. Methods: Over 4-yrs, 29 RYGB pts with symptoms of gastric outlet obstruction presented for endotherapy. 23 F/6 M, age 28-45 (mean 37.5). Pt presentation: rapid wt loss (24), N/V (28), dehydration (5), & dysphagia (2). Pts presented 1-18 mo following RYGB (mean 4). All procedures were done with standard upper scope under fluoro. Dilation was performed using graduated CRE balloons (8-10, 10-12, 12-15) to maximum diameter (8 atm), 60 sec intervals. One CRE balloon sz range was used per endo session. Following dilation, the stoma was injected with a steroid solution (Kenalog 40 mg, mixture 1:4), 1 cc/ quadrant, circumferentially. Results: All underwent successful balloon dil. Dilating sessions ranged from 1-7 (mean 2.4) at 2-wk intervals. This included 8 pts-one dil, 10 pts-two dil, 7 pts-3 dil, 3 pts-4 dil, 1 pt-7 dil. Those pts requiring repeat dil (21) underwent repeat maximum dil with 8-10 CRE (4), 10-12 CRE (11), & 12-15 CRE (7). Need for repeat dil was determined by persistence of initial symptoms, & stoma sz !10 mm at F/U. Estimated stoma diameter prior to dil was 1-8 mm (mean 3.5). None could be traversed with standard scope. Following dil, diameter of stoma increased to 10-15 mm (mean 12.5). Of pts who required a single dil (8), pre dil stoma sz was a mean of 5.6 mm (range 3-8), which increased to a mean of 12.7 mm (range 10-15). Those requiring multiple dil (21), pre dil stoma sz was a mean of 2.6 mm (range 1-4), which increased to a mean of 12.1 mm (range 10-14). 28 of 29 pts had good long-term response at 6-38 mo. One pt with concomitant large stomal ulcer required surgical revision following 7 dil sessions. All pts had resumption of wt loss expected for RYGB following successful endotherapy. Conclusions: Stomal stenosis following RYGB is a common post surgical complication. Endoscopic balloon dil is an effective, nonsurgical option in the treatment of stomal stenosis with no complications observed in this, the largest reported series. Stoma Diameter-mm(mean) Frequency of Dilation Single Multiple Total
www.giejournal.org
Pt (n)
Pre Dilation (mean)
Post Dilation (mean)
8 21 29
5.6 2.6 3.5
12.7 12.1 12.2
T1513 Palliation of Patients with Malignant Gastric Outlet Obstruction with the WallFlex Enteral Stent: A Retrospective Multicentre Study Jeanin Van Hooft, Massimiliano Mutignani, Alessandro Repici, Helmut Messmann, Horst Neuhaus, Paul Fockens Introduction: Gastric outlet obstruction can be a late complication of advanced gastric, periampullary and duodenal carcinoma. Palliation of symptoms of obstruction is the primary aim of treatment in these patients. Self-expandable metal stents (SEMS) have emerged as a promising treatment option. The purpose of this study was to investigate the technical and short-term clinical success (30 days) of a new enteral stent made of nitinol (WallFlex, Boston Scientific) in a multicentre patient cohort. Methods: The first 18 European centres having this stent were approached to collect data of every patient treated. Of these centres 15 returned their data. The collected data were: general patients’ data, type of tumour, complaints, symptom-score (Gastric-Outlet-Obstruction-Scoring-System: a 4-point scoring system from 0 to 3) before and one week after stent placement, procedure related technical data and complications within 30 days. Descriptive statistics were used and the patients’ improvement of GOOSS-score by two points was calculated using the Chi-square test. A GOOSS-score of 2 and 3 was considered a satisfactory quality of diet. Results: Case record forms of 62 patients (35 men, mean age 70 years) were completed. Obstruction was caused by cancer of the stomach in 9, periampullary in 47, duodenal in 1 and metastases in 5. All patients suffered from nausea, vomiting or inability to eat. The median length of the stenosis was 4 cm (1-15 cm). Sixty-six enteral stents (diameter 27/22 mm) were placed: 58 patients required one stent, 4 patients required two stents either because of the position (2) or the length of the stenosis (1) or due to migration (1). Before stent placement 49 patients had no oral intake or were only tolerating liquids (GOOSS-score 0 or 1). The GOOSS-score after one week was obtained from 56 patients (6 patients died): of these 7 were able to tolerate liquids only and 49 patients tolerated soft solids or a low-residue diet (GOOSS-score 2 or 3). A GOOSS-score improved by two points was significant (p Z 0.007). Oral intake was possible on average 1 day (0-8 days) after stent placement. Of the 62 patients enrolled the 30 days follow-up has so far been collected in 59. Complications within 30 days occurred in 11 patients: perforation (2), stent migration (2), tumour ingrowth (1), bleeding (1), aspiration pneumonia (3), cholangitis (1), sepsis of unknown origin (1). Conclusion: WallFlex enteral stent placement for the palliative treatment of patients with malignant gastric outlet obstruction was technical successful in 58 out of 62 (94%) and allowed 49 out of 62 (79%) patients to resume a satisfactory quality of diet.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB245