sa1437 esophageal stenting with sutures: time to redefine our standards?

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Sa1436 Endoscopic Needle-knife Therapy for Ileal Pouch Sinuses in 65 Patients-a Novel Approach for the Surgical Complication Xian-Rui Wu* 1 , Richard C. Wong 2 , Bo Shen 3 1 Departments of Colorectal Surgery, Cleveland Clinic, Cleveland, OH; 2 Division of Gastroenterology and Liver Disease, University Hospitals Case Medical Center, Cleveland, OH; 3 Department of Gastroenterology/ Hepatology, Cleveland Clinic, Cleveland, OH Background: Chronic sinus from anastomotic leak after ileal pouch-anal anastomosis (IPAA) is a common etiology for late-onset abscess, pouch failure, or osteomyelitis. Surgical management of pouch sinus has been challenging due to treatment complexity, complications, and recurrence. Here, for the first time in the literature, we report experience on endoscopic therapy of pouch sinus in a cohort of patients with IPAA. Methods: All patients with pouch sinuses who were treated using endoscopic needle-knife technique from our IRB-approved, prospectively maintained database from 2006-2012 were included in the study. Outpatient pouchoscopy with unroofing of the sinus tract using a needle-knife, with or without probe-based Doppler ultrasound (DopUS) guidance, was performed by a single endoscopist. Complex sinuses were defined as multiple sinuses (2) or compartmentalized sinuses. Demographic and clinical variables together with features of pouch sinuses and their treatment outcome were evaluated. Results: The cohort consisted of 65 patients (male 76.9%). Mean age at diagnosis of pouch sinus was 39.312.1 years. The median duration of UC and pouch, and interval from pouch to the diagnosis of pouch sinus were 5.0 (interquartile range [IQR]: 2.0-13.8) and 4.0 (IQR: 2.0-7.5) years, respectively. The mean depth of the pouches sinus were 4.41.8 cm, with 59 (90.8%) being located at anastomosis, 4 (6.2%) at mid pouch suture line and 2 (3.1%) at the tip of the J. Underlying pouch conditions were pouch procedure-related complications in 14 (21.5%), chronic antibiotic-refractory pouchitis in 8 (12.3%), Crohn’s disease of the pouch in 15 (23.1%), and cuffitis in 9 patients (13.8%). After a median number of 2.0 (IQR: 1.5-3.5) needle knife therapies, pouch sinuses were completely healed in 28 (43.1%) patients. Of the remaining 37 patients, 27 (41.5%) partially responded and 10 (15.4%) failed the therapy. During a mean follow-up of 1.91.1 years from the diagnosis of pouch sinus, 53 patients (81.5%) were able to maintain their pouches. Multivariate analysis showed that a longer duration from colectomy to diagnosis of pouch sinus (Odds ration [OR]: 0.85, 95% confidence interval [CI]: 0.73-0.99, P0.033) and complex sinuses (0.17, 95% CI: 0.04-0.70, P0.014) were negatively associated with, while increased number of needle-knife therapy (1.36, 95% CI: 1.01-1.81, P0.041) would improve the healing the pouch sinuses. Conclusion: In experienced hands, endoscopic needle-knife therapy for pouch sinuses appears to be a feasible, effective, and, safe alternative in managing chronic sinus from IPAA, especially for patients with non-complex sinuses and pouch sinuses occur at a short time after pouch construction. Increasing the numbers of needle-knife therapy also seems to improve the healing of pouch sinuses. Table 1. Outcomes of Needle-Knife Therapy for Pouch Sinus Outcomes Number (%) or Mean SD Follow-up (yrs) 1.91.1 Endoscopic/imaging response None 10 (15.4%) Partial (reduction of sinus) 27 (41.5%) Complete (resolution or epithelization of sinus) 28 (43.1%) Procedure complication (bleeding requiring hospitalization) 1 (1.5%) Number and causes of pouch failure 12 (18.5%) Outcomes Number (%) or Mean SD Pouch sinus with/without anastomotic leak 7 (10.8%) CD of the pouch 3 (4.6%) Chronic antibiotic-refractory pouchitis 2 (3.1%) Table 2. Multivariate Analysis: Factors associated with the Healing the Pouch Sinus. Characteristics Odds Ratio 95% Confidence Interval P value Duration from colectomy to diagnosis of pouch sinus, every 1-yr increase 0.85 0.73-0.99 0.033 Complex sinus (yes vs. no) 0.17 0.04-0.70 0.014 Number of needle-knife therapy, every 1-time increase 1.36 1.01-1.81 0.041 Sa1437 Esophageal Stenting With Sutures: Time to Redefine Our Standards? Reem Z. Sharaiha* 2 , Theodore P. Doukides 1 , Tamas a. Gonda 1 , Jessica L. Widmer 2 , Brian G. Turner 2 , John M. Poneros 1 , Monica Gaidhane 2 , Michel Kahaleh 2 , Amrita Sethi 1 1 Digestive and Liver Diseases, Columbia University Medical Center, New York, NY; 2 Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY Background: Migration is the most common complication of the fully covered metallic self-expanding esophageal stent (FCSEMS). Recent studies have demonstrated migration rates between 30-60%. The aim of this study was to determine the effect of fixation of the FCSEMS by endoscopic suturing on migration rate. Methods: Patients who underwent stent placement for esophageal strictures and leaks over the last year at two academic centers were captured in a dedicated database and reviewed retrospectively. Group A, cases, were patients who underwent suture placement using the OverStitch™ suturing device (Apollo Endosurgery, Austin, TX)and Group B, controls, were patients who had stents without sutures. Basic demographics, indication for stent placements, and adverse events (AE) were collected. Kaplan-Meier analysis and Cox regression modeling were conducted to determine predictors of stent migration patients with and without suture placement. Resolution of symptoms was defined as symptom resolution after stent removal, and stent migration was defined as migration of stent from original placement on follow up endoscopy or imaging. Results: Thirty patients (13 males, 43%), mean age 56.5 (15.6) were treated with esophageal FCSEMS. Twelve patients received sutures (Group A). The indication for stent placement included esophageal stricture, n11, fistulas or leak, n17. No significant differences were noted in age or indication between both groups (see table 1). The Wallflex stent (Boston Scientific, Natick, MA) (n 15) and the BONASTENT (Endochoice, Alpharetta, GA) (n15), with diameters of 18 to 25 mm and lengths of 60 to 150 mm were used. One to two sutures (mean, 1.02 0.66) were used consecutively in 12 patients to fix the upper flared end of the stent with the esophageal mucosal layer. Suturing was technically successful in 100% of patients.Stent migration was noted in a total of 11 of the 30 patients (40%), 1 in group A (8%), and 10 (90 %) in group B. Using Kaplan Meier and log rank analysis, fixation of the stent with suturing reduced the risk of migration (p0.04) (Fig 1). When malignant lesions were excluded, suture placement was still associated with reduced rate of migration (Log rank 0.006). Symptom resolution occurred in 53.3%. There were 3 AE’s noted; all were chest pain post stent insertion (2 patients in Group A, and 1 in Group B). Conclusions: Anchoring of the FCSEMS with endoscopic sutures is technically feasible, safe, and significantly reduces migration rate when compared to no suturing. Although this data represents a small heterogenous group, the results are similar for malignant and non-malignant lesions. A larger prospective study is needed to validate these findings and further identify the patient population that would benefit from suturing of FCEMS at the time of placement. Table 1. Basic indications and resolution of symptom by suture group Suture (12) No Suture (17) P value Age (SD) 54 (11.6) 57.8 (17.9) 0.56 Indication 0.1 Benign Stricture Anastomotic 1 1 Peptic 3 Fistula/Leak Anastomotic 3 2 Fig.2. Anterio-Posterior Suture on isolated pig stomach Abstracts www.giejournal.org Volume 77, No. 5S : 2013 GASTROINTESTINAL ENDOSCOPY AB205

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Page 1: Sa1437 Esophageal Stenting With Sutures: Time to Redefine Our Standards?

Sa1436Endoscopic Needle-knife Therapy for Ileal Pouch Sinuses in 65Patients-a Novel Approach for the Surgical ComplicationXian-Rui Wu*1, Richard C. Wong2, Bo Shen3

1Departments of Colorectal Surgery, Cleveland Clinic, Cleveland, OH;2Division of Gastroenterology and Liver Disease, University HospitalsCase Medical Center, Cleveland, OH; 3Department of Gastroenterology/Hepatology, Cleveland Clinic, Cleveland, OHBackground: Chronic sinus from anastomotic leak after ileal pouch-analanastomosis (IPAA) is a common etiology for late-onset abscess, pouch failure,or osteomyelitis. Surgical management of pouch sinus has been challenging dueto treatment complexity, complications, and recurrence. Here, for the first time inthe literature, we report experience on endoscopic therapy of pouch sinus in acohort of patients with IPAA. Methods: All patients with pouch sinuses who weretreated using endoscopic needle-knife technique from our IRB-approved,prospectively maintained database from 2006-2012 were included in the study.Outpatient pouchoscopy with unroofing of the sinus tract using a needle-knife,with or without probe-based Doppler ultrasound (DopUS) guidance, wasperformed by a single endoscopist. Complex sinuses were defined as multiplesinuses (�2) or compartmentalized sinuses. Demographic and clinical variablestogether with features of pouch sinuses and their treatment outcome wereevaluated. Results: The cohort consisted of 65 patients (male 76.9%). Mean age atdiagnosis of pouch sinus was 39.3�12.1 years. The median duration of UC andpouch, and interval from pouch to the diagnosis of pouch sinus were 5.0(interquartile range [IQR]: 2.0-13.8) and 4.0 (IQR: 2.0-7.5) years, respectively. Themean depth of the pouches sinus were 4.4�1.8 cm, with 59 (90.8%) beinglocated at anastomosis, 4 (6.2%) at mid pouch suture line and 2 (3.1%) at the tipof the J. Underlying pouch conditions were pouch procedure-relatedcomplications in 14 (21.5%), chronic antibiotic-refractory pouchitis in 8 (12.3%),Crohn’s disease of the pouch in 15 (23.1%), and cuffitis in 9 patients (13.8%).After a median number of 2.0 (IQR: 1.5-3.5) needle knife therapies, pouchsinuses were completely healed in 28 (43.1%) patients. Of the remaining 37patients, 27 (41.5%) partially responded and 10 (15.4%) failed the therapy.During a mean follow-up of 1.9�1.1 years from the diagnosis of pouch sinus, 53patients (81.5%) were able to maintain their pouches. Multivariate analysisshowed that a longer duration from colectomy to diagnosis of pouch sinus(Odds ration [OR]: 0.85, 95% confidence interval [CI]: 0.73-0.99, P�0.033) andcomplex sinuses (0.17, 95% CI: 0.04-0.70, P�0.014) were negatively associatedwith, while increased number of needle-knife therapy (1.36, 95% CI: 1.01-1.81,P�0.041) would improve the healing the pouch sinuses. Conclusion: Inexperienced hands, endoscopic needle-knife therapy for pouch sinuses appearsto be a feasible, effective, and, safe alternative in managing chronic sinus fromIPAA, especially for patients with non-complex sinuses and pouch sinuses occurat a short time after pouch construction. Increasing the numbers of needle-knifetherapy also seems to improve the healing of pouch sinuses.

Table 1. Outcomes of Needle-Knife Therapy for Pouch Sinus

OutcomesNumber (%) or

Mean � SD

Follow-up (yrs) 1.9�1.1Endoscopic/imaging responseNone 10 (15.4%)Partial (reduction of sinus) 27 (41.5%)Complete (resolution or epithelization of sinus) 28 (43.1%)Procedure complication (bleeding requiring hospitalization) 1 (1.5%)Number and causes of pouch failure 12 (18.5%)

OutcomesNumber (%) or

Mean � SD

Pouch sinus with/without anastomotic leak 7 (10.8%)CD of the pouch 3 (4.6%)Chronic antibiotic-refractory pouchitis 2 (3.1%)

Table 2. Multivariate Analysis: Factors associated with the Healing the PouchSinus.

CharacteristicsOddsRatio

95% ConfidenceInterval P value

Duration from colectomy to diagnosis of pouchsinus, every 1-yr increase

0.85 0.73-0.99 0.033

Complex sinus (yes vs. no) 0.17 0.04-0.70 0.014Number of needle-knife therapy, every 1-time

increase1.36 1.01-1.81 0.041

Sa1437Esophageal Stenting With Sutures: Time to Redefine OurStandards?Reem Z. Sharaiha*2, Theodore P. Doukides1, Tamas a. Gonda1,Jessica L. Widmer2, Brian G. Turner2, John M. Poneros1,Monica Gaidhane2, Michel Kahaleh2, Amrita Sethi11Digestive and Liver Diseases, Columbia University Medical Center,New York, NY; 2Division of Gastroenterology and Hepatology, WeillCornell Medical College, New York, NYBackground: Migration is the most common complication of the fully coveredmetallic self-expanding esophageal stent (FCSEMS). Recent studies havedemonstrated migration rates between 30-60%. The aim of this study was todetermine the effect of fixation of the FCSEMS by endoscopic suturing onmigration rate. Methods: Patients who underwent stent placement for esophagealstrictures and leaks over the last year at two academic centers were captured in adedicated database and reviewed retrospectively. Group A, cases, were patientswho underwent suture placement using the OverStitch™ suturing device (ApolloEndosurgery, Austin, TX)and Group B, controls, were patients who had stentswithout sutures. Basic demographics, indication for stent placements, andadverse events (AE) were collected. Kaplan-Meier analysis and Cox regressionmodeling were conducted to determine predictors of stent migration patientswith and without suture placement. Resolution of symptoms was defined assymptom resolution after stent removal, and stent migration was defined asmigration of stent from original placement on follow up endoscopy or imaging.Results: Thirty patients (13 males, 43%), mean age 56.5 (�15.6) were treatedwith esophageal FCSEMS. Twelve patients received sutures (Group A). Theindication for stent placement included esophageal stricture, n�11, fistulas orleak, n�17. No significant differences were noted in age or indication betweenboth groups (see table 1). The Wallflex stent (Boston Scientific, Natick, MA) (n �15) and the BONASTENT (Endochoice, Alpharetta, GA) (n�15), with diametersof 18 to 25 mm and lengths of 60 to 150 mm were used. One to two sutures(mean, 1.02 �0.66) were used consecutively in 12 patients to fix the upperflared end of the stent with the esophageal mucosal layer. Suturing wastechnically successful in 100% of patients.Stent migration was noted in a total of11 of the 30 patients (40%), 1 in group A (8%), and 10 (90 %) in group B. UsingKaplan Meier and log rank analysis, fixation of the stent with suturing reducedthe risk of migration (p�0.04) (Fig 1). When malignant lesions were excluded,suture placement was still associated with reduced rate of migration (Log rank�0.006). Symptom resolution occurred in 53.3%. There were 3 AE’s noted; allwere chest pain post stent insertion (2 patients in Group A, and 1 in Group B).Conclusions: Anchoring of the FCSEMS with endoscopic sutures is technicallyfeasible, safe, and significantly reduces migration rate when compared to nosuturing. Although this data represents a small heterogenous group, the resultsare similar for malignant and non-malignant lesions. A larger prospective study isneeded to validate these findings and further identify the patient population thatwould benefit from suturing of FCEMS at the time of placement.

Table 1. Basic indications and resolution of symptom by suture group

Suture (12) No Suture (17) P value

Age (SD) 54 (11.6) 57.8 (17.9) 0.56Indication 0.1Benign

StrictureAnastomotic 1 1Peptic 3

Fistula/LeakAnastomotic 3 2

Fig.2. Anterio-Posterior Suture on isolated pig stomach

Abstracts

www.giejournal.org Volume 77, No. 5S : 2013 GASTROINTESTINAL ENDOSCOPY AB205

Page 2: Sa1437 Esophageal Stenting With Sutures: Time to Redefine Our Standards?

Suture (12) No Suture (17) P value

Post Bariatric 6 3Tracheoesophageal 3

MalignantStricture 2 5

Resolution of Stricture 7(58%) 9 (50%) 0.72

Sa1438Use of an Endoscopic Suturing System to Prevent StentMigrationLarissa Fujii*1, Eduardo a. Bonin2, Christopher J. Gostout1,Louis M. Wong Kee Song1

1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester,MN; 2Instituto Jacques Perissat, Curitiba, BrazilBackground: Covered self-expandable metal stents (CSEMS) are increasinglybeing utilized for management of benign disease, including strictures, fistulas,anastomotic leaks, and perforations, particularly in the upper gastrointestinaltract. However, stent migration remains a major limitation, occurring in up to62% in some series, resulting in repeated, costly interventions. We describe ourexperience using an endoscopic suturing device to anchor CSEMS and minimizemigration. Methods: All patients who underwent stent fixation using anendoscopic suturing system (Overstitch, Apollo Endosurgery, Austin, TX) at ourinstitution were identified using a prospectively maintained endoscopy database.Data were abstracted for patient demographics, indications for stent placement,prior history of stent placement and migration, technical success, number ofsutures utilized for stent fixation, rate of stent migration despite suture fixation,clinical success (defined as resolution of symptoms or underlying problem), andprocedure-related adverse events (AEs). All upper procedures were performedunder anesthesia support, whereas the single lower endoscopic procedure wasperformed under moderate sedation. Scheduled CSEMS removal was performedat 4-12 weeks post placement with suture sectioning using endoscopic scissorsor argon plasma coagulation. Results: A total of 14 patients (12 men) with meanage of 63 years (range 17-85 years) underwent stent anchoring procedures usingthe endoscopic suturing device (Table 1). The technical success rate for stentplacement and fixation was 100%, and the number of sutures utilized rangedfrom 1 to 5. There were no AEs related specifically to the suturing procedure,though stent-induced tracheoesophageal fistula occurred in 1 patient. Stentmigration occurred in 3 (21%) patients at 7, 15 and 40 days post-proceduredespite suture fixation. However, stent migration was prevented by suturefixation in 5 of 7 (71%) patients in whom prior stent placement resulted inmigration. Clinical success was durable in 7 (50%) patients, but transient in 3patients (21%) in whom symptom recurrence or abnormal imaging occurred at amean of 28 days (range 16-40 days) post stent removal. The remaining patientshad incomplete or no resolution of symptoms or underlying condition followingstent removal. Conclusions: The use of an endoscopic suturing system for stentfixation is feasible and safe. Although stent migration occurred despite suturefixation, it prevented migration in a substantial proportion of patients in whomprior stenting resulted in stent migration. Prospective comparative trials areawaited to determine the long-term efficacy and safety of endoscopic suturing toanchor endoluminal stents.

Table 1. Patient Characteristics

Pt Indication

PriorStenting

(#Attempts)

SEMS(mm

length �

mmdiameter)

#Sutures

SEMSMigration

DespiteSuture

FixationClinicalSuccess Complication

1 Gastrogastricanastomotic

stricture

N PC-SEMS(150 � 23)

1 N Complete N

2 Gastrocutaneousfistula

N FC-SEMS(100 x 18)

2 N Incomplete Y (dysphagia)

3 Enterocolic fistula N PC-SEMS(100 � 23)

2 N Complete N

4 Tracheoesophagealfistula

N FC-SEMS(70 � 18)

3 Y Incomplete N

5 Esophagogastricanastomoticdehiscence

Y (1) FC-SEMS(120 � 18)

3 N Complete Y (stent-inducedtracheoesophageal

fistula)6 Esophagogastric

anastomoticstricture

Y (6) FC-SEMS(100 � 18)

1 Y Transient N

7 Esophagogastricanastomotic

stricture

N FC-SEMS(100 � 18)

3 N Transient N

8 Colorectalanastomotic

stricture

N FC-SEMS(70 � 18)

3 N Complete N

9 Esophagealperforation

Y FC-SEMS(100 � 23)

3 N Complete N

10 Esophagealstricture

Y (3) FC-SEMS(120 � 18)

4 N Complete N

11 Gastrojejunalanastomotic

stricture

Y (1) FC-SEMS(100 � 18)

5 Y Transient N

12 Esophagealperforation

Y (1) FC-SEMS(120 � 23)

2 N Incomplete N

13 Chronicjejunocutaneous

fistula

N FC-SEMS(70 � 18)

3 N Incomplete N

14 Esophagogastricanastomotic

stricture

Y (3) PC-SEMS(100 � 18)

2 N Complete N

Y� yes; N� no; FC� fully covered; PC� partially covered; SEMS� self-expanding metal stent

Sa1439Prevention of Distal Migration of Self-Expanding EsophagealMetallic Stents Using a Combine Technique With Band Ligationand Endoscopic ClipsAlberto Baptista1, Maria a. Guzman1, Jose Di Giorgio*1,Frank Figueroa3, Victor J. Zambrano2, Camilo Morantes5,Carlos Ananguren4

1Gastroenterology, Hospital de Clinicas Caracas, Caracas, Venezuela;2Surgery, Policlinica Metropolitana, Caracas, Venezuela;3Gastroenterology, Policlinica Barquisimeto, Barquisimeto, Venezuela;4Gastroenterology, Clinica Chilemex, Puerto Ordaz, Venezuela;5Gastroenterology, Clinica IDB, Barquisimeto, VenezuelaIntroduction: One of the common complications of the self-expandingesophageal metallic stents in the management of benign non-stenotic pathologiessuch as fistules is the distal migration of the stent. This situation presents moreoften in patients with leaks after sleeve gastrectomy and leaks in thegastroyeyuno anastomosis after total gastrectomy procedures. Objectives: reducethe self-expanding esophageal metallic stent migration, using band ligation tocreate a narrowed zone that provides a cleavage to the esophageal stent. Patientsand Methods: we present a 26 patients case series, 22 with post sleevegastrectomy leaks, two patients presented leaks in the gastroyeyuno anastomosisafter total gastrectomy procedures and two with esophageal fistules aftergunshots wounds. None of these patients presented a narrowed area thatprovides a correct cleavage to the stent. Three to six bands were placed in helixdisposition with 1cm between each other, in the area were the upper half of thestent should be deployed. With the stent in place, we used two to fourendoscopic clips to fix the upper edge of the stent to the esophageal mucosa.Stents were removed 6 to 8 weeks after their placement. Results: Distal migrationoccured in two of the twenty six cases (7,7 %). Not a single case of stenosispresented in the 26 cases during a mean endoscopic follow-up of 12 months.Conclusion: Since this is a descriptive study and not a prospective comparativeone, no conclusions about the difference between using combine techniques oronly one of them can be made, however, the stents migration rate in our seriesappears to be very promising for being lower of the reported in the literature(between 16 and 50 Vs 7.7%). The higher cost of combination technique can be

Fig 1. Time to Stent Migration.

Abstracts

AB206 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5S : 2013 www.giejournal.org