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Utility of an endoscopic suturing system for prevention of covered luminal stent migration in the upper GI tract
CASE STUDIES
Utility of an endoscopic suturing system for prevention of covered luminal stent migration in the upper GI tract Larissa L. Fujii, MD, Eduardo A. Bonin, MD, Todd H. Baron, MD, Christopher J. Gostout, MD, Louis M. Wong Kee Song, MD Rochester, Minnesota, USA
Endoluminal stents are increasingly being used for management of benign conditions, such as refractory strictures, fistulas, anastomotic leaks, and perforations.1-7 However, stent migration remains problematic, particularly when there is no luminal narrowing or shelf to anchor the stent, and high migration rates of 53% to 58% have been reported in some studies.6,7 In 2 recent, small, feasibility studies, an endoscopic suturing system (OverStitch; Apollo Endosurgery, Inc, Austin, Tex) was used for anchoring selfexpandable metal stents (SEMSs) in the upper GI tract.8,9 Herein, we present the largest single-center case series on the utility of this suturing device for prevention of SEMS migration in benign conditions.
PATIENTS AND METHODS All patients who underwent endoscopic suture fixation of SEMSs in the upper GI tract at our institution between November 2010 and January 2013 were identified from a prospectively maintained endoscopy database. Data were abstracted for patient demographics, indications for SEMS placement, prior SEMS migration and replacement, types of SEMSs placed, location and number of sutures used, technical success, rate of stent migration despite suture fixation, clinical success (defined as resolution of symptoms and/or underlying condition), and procedurerelated adverse events. The study was approved by the Institutional Review Board of Mayo Clinic. Abbreviations: SEMS, self-expandable metal stent. DISCLOSURE: C. Gostout is a member of, advisor for, and equity holder in Apollo Endosurgery Inc. No other financial relationships relevant to this publication were disclosed. Copyright ª 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.06.014
All upper endoscopic procedures were performed with patients under general anesthesia. The first-generation OverStitch suturing device was used until January 2012, at which time the second-generation instrument became available. There are no differences in suturing capability between the 2 systems. The proximal flange of the SEMS was anchored to the GI wall by placing from 1 to 5 interrupted 2-0 polypropylene sutures based on ease of access for suture placement (Fig. 1). It has been our practice to place interrupted sutures for stent anchoring, similar to previous series. Elective removal of stents was performed from 1 to 6 months later by using a rat-tooth forceps after transecting the sutures with argon plasma coagulation at a setting of 60 W and 1 L/minute argon flow rate. Preparation and use of the endoscopic suturing system were as previously described.8-10 In brief, the device is mounted onto a double-channel endoscope and consists of a suture anchor with a detachable needle tip that is passed through 1 accessory channel and coupled to the curved suturing arm of the device. The handle component of the device, affixed at the entrance port of the working channel, actuates needle transfer and movement of the suture arm, enabling passage and exit of the suture through tissue and stent. A suture-cinching tool is used to tighten and secure the deployed suture, which can be placed in an interrupted or running fashion. Continuous variables are reported as means and standard deviation (SD) or medians and range. Means were reported unless the SD was larger than the mean itself, in which case medians were reported. A t test was used for continuous variables, and a Pearson chi-square test was used for categorical variables. Analysis of variance was used to analyze procedure duration over time as experience is gained with the device. A P value of ! .05 was considered statistically significant.
Received March 15, 2013. Accepted June 17, 2013. Current affiliations: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
RESULTS
Reprint requests: Louis M. Wong Kee Song, MD, Mayo Clinic, Division of Gastroenterology and Hepatology, 200 1st Street SW, Rochester, MN 55905.
Eighteen patients (mean [ SD] age 61 [ 18] years; 14 men) underwent a total of 21 endoscopic suturing procedures to anchor SEMSs (Table 1). Patient 10 underwent
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Endoscopic suturing system for prevention of stent migration
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Figure 1. A, Esophagogastric anastomotic stricture refractory to balloon dilation. B, Self-expandable metal stent placed. C, Anchoring of SEMS by using the OverStitch suturing device, OverStitch; Apollo Endosurgery, Inc, Austin, Tex. D, Fixation of SEMS to the esophageal wall with 3 interrupted sutures. E, Fluoroscopic image showing waist in mid-portion of SEMS and 3 radiopaque suture tags (arrows). SEMS, self-expandable metal stent.8
at total of 3 and patient 15 a total of 2 procedures with endoscopic suture fixation of a SEMS. Indications for stent placement were strictures refractory to dilation (n Z 7) and sealing of perforations (n Z 5), fistulas (n Z 5), and an anastomotic leak (n Z 1). These indications were a result of prior surgical procedures or failed surgical correction of a spontaneous perforation in 11 patients (61%) and 1 patient, (6%), respectively. Most patients (68%) had prior endoscopic interventions including stent placement without fixation (n Z 7), stricture
dilation (n Z 2), or both (n Z 4). In those who underwent stricture dilation, a median of 8 dilations (range 1-11) were performed before stent placement with suture fixation. A median of 1 stent (range 1-5) was placed before suture anchoring in 11 patients. Of 19 total previously placed stents, 14 (74%) migrated at a median of 19 days (range 0-391 days), 3 (16%) were found to be in place and were removed endoscopically at a median of 38 days (range 16-52 days), and the remaining 2 were removed at surgery at 4 and 33 days after placement.
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Endoscopic suturing system for prevention of stent migration
The mean ( SD) size for fistula and perforation defects was 16 ( 13) mm. Ten patients underwent 1 or more adjunctive therapies, including endoscopic suturing of the defect before stent placement (n Z 9), over-theendoscope clip (Ovesco Endoscopy, Tubingen, Germany) placement (n Z 2), through-the-endoscope clip placement (n Z 1), and fibrin glue injection (n Z 2) or argon plasma coagulation of the fistulous tract (n Z 1). Endoscopic suturing or clip placement enabled approximation of the edges of the defect, but initial complete closure by using a combination of a percutaneously placed fibrin sealant and endoscopic suturing before stent placement was successful in only 1 patient (patient 12). Because of the extent and chronicity of the fistula in this patient, a fully covered stent was placed despite apparent complete closure by using the fibrin sealant and endoscopic suturing to increase the probability of durable clinical success. Suture-anchored stents included fully covered SEMSs (83%) and partially covered SEMSs (17%), with a mean ( SD) length of 110 ( 25) mm and body diameter of 18 mm (n Z 14) or 23 mm (n Z 4). Endoscopic suturing of SEMSs was performed in the esophagus (n Z 15) and stomach (n Z 3). Eleven of 21 endoscopic suturing procedures (52%) were performed in the outpatient setting, and the remainder in hospitalized patients. Although an esophageal overtube was used in 5 procedures (24%) early in the clinical experience, subsequent procedures were performed without an overtube. All sutures were placed in an interrupted fashion, with a mean ( SD) of 2.6 ( 1) sutures used for stent fixation. The mean ( SD) procedure time, which included stent placement and adjunctive therapies, was 78 ( 40) minutes. As expected, the mean ( SD) procedure time in patients who received adjunctive therapies was significantly longer than in those without additional therapies (102 [ 32] minutes vs 48 [ 27] minutes; P Z .001). Procedure duration also decreased over time as experience in using the device accumulated (P Z .04). The technical success for placement and suture anchoring of stents was 100%. Despite suture fixation, stent migration occurred in 7 of 21 SEMSs (33%) placed (including those placed at subsequent procedures) at a median of 21 days (range 7-40 days). There was no association between the number of anchoring sutures placed and whether the stent migrated, but there was a trend toward increased stent migration despite suture placement when a laser cut stent (Alimaxx-ES; Merit Medical Endotek, South Jordan, Utah) was used in contrast to a braided stent (Wallflex; Boston Scientific Corp, Natick, Mass) (60% vs 15%; P Z .06). Stent migration was managed with stent replacement and repeat suture anchoring in 2 patients (patients 10 and 15), stricture dilation in 2 patients (patients 6 and 14), and endoscopic suturing of the defect in 1 patient (patient 4) (Table 1). Repeat stent placement was not performed in the latter 3 patients because after removal of the migrated stent, the esophageal stricture
appeared mild in severity and amenable to infrequent dilations (patients 6 and 14) or the patient had difficulty tolerating the high esophageal location of the stent (patient 4). Complete clinical success was achieved in 10 patients (56%), with resolution of symptoms and/or underlying disease at a mean ( SD) follow-up of 75 ( 55) days. In this group of patients, 3 died from unrelated causes with the stent still in place at a mean ( SD) of 46 ( 39) days, 1 died from an unrelated cause 3 days after stent removal, 5 had their stents removed as a planned procedure at a mean ( SD) of 75 ( 70) days, and 1 patient had his stent removed during surgical repair of a stent-induced tracheoesophageal fistula. Partial clinical success, with initial symptom improvement but recurrence of symptoms or luminal defect, was achieved in 6 patients (33%), with repeat endoscopic procedures at a mean ( SD) of 24 ( 11) days. In this group of patients, 1 patient (patient 2) required a proximal esophagogastrectomy with end-to-side esophagojejunostomy 9 months later for a persistent gastric fistula after Nissen fundoplication, and 1 patient (patient 10) died from an underlying malignancy after having repeated endoscopic stent placement with suture fixation. The remaining patients were managed with further stricture dilation (n Z 3) and fistula plug placement (n Z 1) (Table 1). Two patients (11%) did not clinically improve with stent placement; 1 required surgical repair of an esophageal perforation, and the other required home parenteral nutrition after further attempts to close a fistula by using endoscopic suturing, and an over-the-endoscope clip failed. Patients with complete clinical success were more likely to have placement of longer and wider SEMSs than those with partial or no success (Table 2). There was a trend toward the use of a partially covered stent and complete clinical success, but the sample size was too small to make any meaningful assessment. Although no adverse events occurred as a direct result of the suturing procedure, a SEMS-related tracheoesophageal fistula occurred in 1 patient (patient 5) at 28 days after SEMS placement and in the setting of ongoing external beam radiotherapy. The tracheoesophageal fistula was not in proximity to the sutures and required surgical repair.
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DISCUSSION Although SEMSs are approved for palliation of malignant obstruction, they are increasingly being used for management of benign diseases, such as refractory strictures, perforations, leaks, and fistulas.1-7 However, stent migration is a major limitation, particularly in conditions where a shelf or luminal constriction for holding the stent is absent. The use of through-the-endoscope clips for stent anchoring is of limited value.9 Placement of partially covered SEMSs may reduce the migration rate as the
Endoscopic suturing system for prevention of stent migration
Fujii et al
TABLE 1. Patient characteristics and outcomes following endoscopic suture fixation of stents
Patient
Age/sex
Prior surgery
Indication for SEMS
Type of SEMS (length 3 body diameter, mm)
1
81/F
Repair of Nissen fundoplication
Gastric fistula
PC-Wallflex* (155 23)
2
44/F
Nissen fundoplication
Gastrocutaneous fistula
FC-Alimaxxy (100 18)
3
80/M
Repair of perforated duodenal ulcer
Enterocolonic fistula
PC-Wallflex* (105 23)
4
17/M
Esophageal atresia s/p multiple surgeries
Tracheoesophageal fistula
5
68/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic dehiscence
FC-WallFlex* (120 18)
6
72/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic stricture
FC-Alimaxxy (100 18)
7
56/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic stricture
FC-WallFlex* (100 18)
8
50/M
–
Esophageal perforation
FC-WallFlex* (100 23)
9
72/M
–
Esophageal stricture
FC-WallFlex* (120 18)
10
55/M
Pancreatic cancer s/p Whipple’s resection
Gastrojejunal anastomotic stricture
FC-WallFlex* (100 18)
11
71/M
–
Esophageal perforation
FC-WallFlex* (120 23)
12
62/M
Billroth II for gastric cancer complicated by ischemic bowel s/p gastrojejunal anastomosis
Chronic jejunocutaneous fistula
13
85/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic stricture
PC-WallFlex* (103 18)
14
32/M 57/M
Esophagogastric anastomotic stricture Esophageal stricture
FC-Alimaxxy (70 18)
15
Esophagectomy for esophageal perforation –
FC-WallFlex* (150 18)
16
41/M
–
Esophageal perforation
FC-WallFlex* (120 18)
17
72/F
–
Esophageal perforation
FC-WallFlex* (120 18)
18
75/F
Esophageal perforation
FC-WallFlex* (120 18)
Failed repair of Boerhaave syndrome
FC-Alimaxxy (70 x 18)
FC-Alimaxxy (70 18)
SEMS, Self-expandable metal stent; F, female; M, male; PC, partially covered; FC, fully covered; s/p, status post; OTSC, over-the-scope clip; –, not applicable. *WallFlex; Boston Scientific Corp, Natick, Mass. yAlimaxx; Merit Medical Endotek, South Jordan, Utah.
uncovered portions of the SEMS embed into tissue, but subsequent stent removal may be problematic and costly if complex retrieval techniques, such as the stent-in-stent method, are required.11
Endoscopic suturing is a promising technique for preventing stent migration, as shown recently in proof-of-principle studies.8,9 Our study demonstrates the utility of this technique in a larger number of patients
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TABLE 1.
Continued
Prior SEMS migration/#
Location/no. of sutures used
SEMS migration despite suture fixation/days
Overstitch-related adverse events
Clinical success
Outcome at last follow-up
–
Esophagus/1
No
No
Complete
Died 5 days later from respiratory failure
–
Esophagus/2
No
No
Partial
Surgery 9 months later with fistula resolution
–
Stomach/2
No
No
Complete
Died 50 days later from ischemic bowel
–
Esophagus/3
Yes/23
No
Partial
Repeat EGD with suture closure of the fistula followed by a repeat EGD with fistula plug and OTSC placement
Yes/1
Esophagus/3
No
No
Complete
Tracheoesophageal fistula induced by SEMS requiring surgical closure
Yes/5
Esophagus/1
Yes/40
No
Partial
Periodic dilations as needed
–
Esophagus/3
No
No
Partial
Periodic dilations as needed
–
Esophagus/3
No
No
Complete
No further therapy
Yes/2
Esophagus/4
No
No
Complete
No further therapy; stent removed 6 months later
Yes/1
Stomach/5
Yes/7
No
Partial
Underwent 2 repeat suture fixations of SEMS but died 2 months later from pancreatic cancer
Yes/1
Esophagus/2
No
No
Complete
Died 5 months later from unknown cause
Stomach/3
No
No
None
Repeat endoscopy with fistula suturing and OTSC placement
Yes/2
Esophagus/2
No
No
Complete
Died 3 months later from colon cancer
No (removed after 27 days for pain) Yes/1
Esophagus/3
Yes/21
No
Partial
Periodic dilations as needed
Esophagus/2
Yes/9
No
Complete
Symptom resolution with repeat stent placement and suture fixation
–
Esophagus/2
No
No
Complete
No further therapy
Yes/1
Esophagus/3
No
No
None
Surgery for closure 5 days later
–
Esophagus/2
No
No
Complete
No further therapy
–
who underwent the procedure for various benign indications, even though our tertiary-care patient cohort presented with complex underlying conditions and a high stent migration rate before suture fixation. Although the
technical success rate was 100%, stent migration occurred in one-third of the procedures in spite of suture fixation. Potential reasons include the use of interrupted rather than running sutures, superficial placement of the stitches
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TABLE 2. Feature comparison between complete and partial/no clinical success following stent placement with suture fixation Complete clinical success (n [ 10)
Partial or no clinical success (n [ 8)
P value
68 (14)
51 (19)
.05
Male
8
6
.80
Underlying malignancy
2
4
.18
Previous surgery
5
7
.09
10 (18)
15 (15)
.65
Prior endoscopic therapy
6
6
.50
Inpatient setting
7
2
.05
Esophageal location of sutures
9
6
.39
Size of defect, mean (SD), mm
16.2 (11.1)
16.3 (16)
.99
Use of adjunctive therapies
6
4
.67
Use of partially covered SEMS
3
0
.08
123 (19)
93 (20)
.005*
6 (60)
8 (100)
.04*
Age, mean (SD), y
Time since previous surgery, mean (SD), mo
Length of SEMS, mean (SD), mm Use of smaller body diameter (18 mm) SEMS, no. (%) SD, Standard deviation; SEMS, self-expandable metal stent. *Significant.
in tissue, and suturing of laser cut stents where the joints may separate if the covering is disrupted. However, suture fixation prevented stent migration in a substantial proportion of patients in whom prior SEMS placement resulted in migration. The migration rate for stents that were anchored was 33% as compared with 74% for stents placed without suture fixation in the same patients. Furthermore, 19 stents were placed before the suture fixation procedure, as opposed to only 3 after the procedure. Therefore, endoscopic suturing to anchor stents potentially can reduce the total number of procedures required and should be given consideration at the index endoscopy for SEMS placement or after the first instance of stent migration. To further enhance the potential cost effectiveness of suture fixation of the SEMS in a patient with a migrated stent, the endoscopist may consider repositioning and suturing the migrated stent rather than placing a new stent, as described by Kantsevoy and Bitner.8 A limitation and bias of our study is that an algorithm was not in place in triaging which patients should undergo endoscopic stent suturing, particularly those who did not have previous stent migration, and the decision was left at the discretion of the endoscopist, based on the perceived risk of migration (eg, prior stent migration or absence of a shelf to hold the stent). After stent anchoring, clinical success was complete and partial in 56% and 33% of procedures, respectively. Clinical success is a function of the stent rather than the suturing procedure per se, and an association between complete clinical success and placement of longer and larger-diameter stents may be inferred from analysis of 792 GASTROINTESTINAL ENDOSCOPY Volume 78, No. 5 : 2013
our data. However, the validity of this finding is unclear because of the small number of patients in each group and the potential confounder of higher migration with laser cut stents. Therefore, further studies that address potential relationships between stent characteristics and the likelihood of clinical success in the setting of benign disease are awaited. Although no adverse events were attributed to the suturing procedure, SEMS placement in a postesophagectomy patient undergoing radiotherapy resulted in a tracheoesophageal fistula at the proximal flange of the stent at a distance from the suture sites. Although it is theoretically possible that a deep suture needle puncture through the esophageal wall could injure surrounding structures, such as the trachea, actuation and position of the curved needle arm of the suturing device can be controlled to avoid a deep tissue “bite.” In conclusion, anchoring of SEMSs by using an endoscopic suturing device was shown to be feasible, safe, and relatively effective at preventing stent migration, particularly in patients with benign conditions in whom stent migration had already occurred.
REFERENCES 1. Salminen P, Gullichsen R, Laine S. Use of self-expandable metal stents for the treatment of esophageal perforations and anastomotic leaks. Surg Endosc 2009;23:1526-30. 2. Thomas T, Abrams KR, Subramanian V, et al. Esophageal stents for benign refractory strictures: a meta-analysis. Endoscopy 2011;43:386-93.
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Osada et al
Wound healing of large mucosal defects
3. van Boeckel PG, Dua KS, Weusten BL, et al. Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-expandable plastic stents for the treatment of benign esophageal ruptures and anastomotic leaks. BMC Gastroenterol 2012;12:19. 4. van Boeckel PG, Sijbring A, Vleggaar FP, et al. Systematic review: temporary stent placement for benign rupture or anastomotic leak of the oesophagus. Aliment Pharmacol Therap 2011;33:1292-301. 5. van Heel NC, Haringsma J, Spaander MC, et al. Short-term esophageal stenting in the management of benign perforations. Am J Gastroenterol 2010;105:1515-20. 6. Dan DT, Gannavarapu B, Lee JG, et al. Removable esophageal stents have poor efficacy for the treatment of refractory benign esophageal strictures (RBES). Dis Esophagus. Epub 2012 Nov 2.
7. Sharma P, Kozarek R. Role of esophageal stents in benign and malignant diseases. Am J Gastroenterol 2010;105:258-73. 8. Kantsevoy SV, Bitner M. Esophageal stent fixation with endoscopic suturing device (with video). Gastrointest Endosc 2012;76:1251-55. 9. Rieder E, Dunst CM, Martinec DV, et al. Endoscopic suture fixation of gastrointestinal stents: proof of biomechanical principles and early clinical experience. Endoscopy 2012;44:1121-26. 10. Bonin EA, Wong Kee Song LM, Gostout ZS, et al. Closure of a persistent esophagopleural fistula assisted by a novel endoscopic suturing system. Endoscopy 2012;44(suppl 2 UCTN):E8-9. 11. Hirdes MM, Siersema PD, Houben MH, et al. Stent-in-stent technique for removal of embedded esophageal self-expanding metal stents. Am J Gastroenterol 2011;106:286-93.
Process of wound healing of large mucosal defect areas that were sutured by using a loop clip–assisted closure technique after endoscopic submucosal dissection of a colorectal tumor Taro Osada, MD, PhD, Naoto Sakamoto, MD, PhD, Hideaki Ritsuno, MD, Takashi Murakami, MD, Hiroya Ueyama, MD, PhD, Tomoyoshi Shibuya, MD, PhD, Kenshi Matsumoto, MD, PhD, Akihito Nagahara, MD, PhD, Tatsuo Ogihara, MD, PhD, Sumio Watanabe, MD, PhD Tokyo, Japan
Endoscopic submucosal dissection (ESD) is indicated for the treatment of large, superficial colorectal tumors.1-4 However, as a result of ESD, large mucosal defect areas are made. Wound healing of artificial defect areas in the large intestine is thought to be influenced by exposure to stool, some types of enterobacteria, and peristaltic movement.5-6 Serious adverse events such as bleeding and perforation are often associated with endoscopic resections, especially when the lesions removed are large.7-8 Endoscopic clips have been used commonly for endoscopic closure of EMR defects to prevent or treat bleeding or perforation.9-10 They can be used when the diameter of the defect is smaller or larger than the width of the open clip. However, when the mucosal defect is larger than the diameter of the open clip, several clips are used. The
Abbreviations: ESD, endoscopic submucosal dissection. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. This work was supported in part by Grant-in-Aid for Scientific Research (C) (No. 23591023 to T.O. and N.S.) from the Ministry of Education, Culture, Sports, Science, and Technology of Japan.
Figure 1. Loop clip. The loop clip consists of an endoscopic clip and looped nylon string. It can be passed through the instrument channel of the endoscope.
Reprint requests: Taro Osada, Department of Gastroenterology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
first clip is attached at 1 of the edges of the defect, the second clip is attached adjacent to the first clip, the third clip is attached adjacent to the second clip, and so on until the defect is closed. However, this method is difficult, cumbersome, and not always feasible. We have designed a new closure device for large mucosal defects, named a loop clip, which makes it easy to close any mucosal defect completely when used with conventional endoscopic clips.11-12 Closure of the mucosal defect by using endoscopic clips is presumed to reduce the risk of adverse
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Copyright ª 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.05.035 Received February 8, 2013. Accepted May 30, 2013. Current affiliations: Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.
Utility of an endoscopic suturing system for prevention of covered luminal stent migration in the upper GI tract Larissa L. Fujii, MD, Eduardo A. Bonin, MD, Todd H. Baron, MD, Christopher J. Gostout, MD, Louis M. Wong Kee Song, MD Rochester, Minnesota, USA
Endoluminal stents are increasingly being used for management of benign conditions, such as refractory strictures, fistulas, anastomotic leaks, and perforations.1-7 However, stent migration remains problematic, particularly when there is no luminal narrowing or shelf to anchor the stent, and high migration rates of 53% to 58% have been reported in some studies.6,7 In 2 recent, small, feasibility studies, an endoscopic suturing system (OverStitch; Apollo Endosurgery, Inc, Austin, Tex) was used for anchoring selfexpandable metal stents (SEMSs) in the upper GI tract.8,9 Herein, we present the largest single-center case series on the utility of this suturing device for prevention of SEMS migration in benign conditions.
PATIENTS AND METHODS All patients who underwent endoscopic suture fixation of SEMSs in the upper GI tract at our institution between November 2010 and January 2013 were identified from a prospectively maintained endoscopy database. Data were abstracted for patient demographics, indications for SEMS placement, prior SEMS migration and replacement, types of SEMSs placed, location and number of sutures used, technical success, rate of stent migration despite suture fixation, clinical success (defined as resolution of symptoms and/or underlying condition), and procedurerelated adverse events. The study was approved by the Institutional Review Board of Mayo Clinic. Abbreviations: SEMS, self-expandable metal stent. DISCLOSURE: C. Gostout is a member of, advisor for, and equity holder in Apollo Endosurgery Inc. No other financial relationships relevant to this publication were disclosed. Copyright ª 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.06.014
All upper endoscopic procedures were performed with patients under general anesthesia. The first-generation OverStitch suturing device was used until January 2012, at which time the second-generation instrument became available. There are no differences in suturing capability between the 2 systems. The proximal flange of the SEMS was anchored to the GI wall by placing from 1 to 5 interrupted 2-0 polypropylene sutures based on ease of access for suture placement (Fig. 1). It has been our practice to place interrupted sutures for stent anchoring, similar to previous series. Elective removal of stents was performed from 1 to 6 months later by using a rat-tooth forceps after transecting the sutures with argon plasma coagulation at a setting of 60 W and 1 L/minute argon flow rate. Preparation and use of the endoscopic suturing system were as previously described.8-10 In brief, the device is mounted onto a double-channel endoscope and consists of a suture anchor with a detachable needle tip that is passed through 1 accessory channel and coupled to the curved suturing arm of the device. The handle component of the device, affixed at the entrance port of the working channel, actuates needle transfer and movement of the suture arm, enabling passage and exit of the suture through tissue and stent. A suture-cinching tool is used to tighten and secure the deployed suture, which can be placed in an interrupted or running fashion. Continuous variables are reported as means and standard deviation (SD) or medians and range. Means were reported unless the SD was larger than the mean itself, in which case medians were reported. A t test was used for continuous variables, and a Pearson chi-square test was used for categorical variables. Analysis of variance was used to analyze procedure duration over time as experience is gained with the device. A P value of ! .05 was considered statistically significant.
Received March 15, 2013. Accepted June 17, 2013. Current affiliations: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
RESULTS
Reprint requests: Louis M. Wong Kee Song, MD, Mayo Clinic, Division of Gastroenterology and Hepatology, 200 1st Street SW, Rochester, MN 55905.
Eighteen patients (mean [ SD] age 61 [ 18] years; 14 men) underwent a total of 21 endoscopic suturing procedures to anchor SEMSs (Table 1). Patient 10 underwent
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Figure 1. A, Esophagogastric anastomotic stricture refractory to balloon dilation. B, Self-expandable metal stent placed. C, Anchoring of SEMS by using the OverStitch suturing device, OverStitch; Apollo Endosurgery, Inc, Austin, Tex. D, Fixation of SEMS to the esophageal wall with 3 interrupted sutures. E, Fluoroscopic image showing waist in mid-portion of SEMS and 3 radiopaque suture tags (arrows). SEMS, self-expandable metal stent.8
at total of 3 and patient 15 a total of 2 procedures with endoscopic suture fixation of a SEMS. Indications for stent placement were strictures refractory to dilation (n Z 7) and sealing of perforations (n Z 5), fistulas (n Z 5), and an anastomotic leak (n Z 1). These indications were a result of prior surgical procedures or failed surgical correction of a spontaneous perforation in 11 patients (61%) and 1 patient, (6%), respectively. Most patients (68%) had prior endoscopic interventions including stent placement without fixation (n Z 7), stricture
dilation (n Z 2), or both (n Z 4). In those who underwent stricture dilation, a median of 8 dilations (range 1-11) were performed before stent placement with suture fixation. A median of 1 stent (range 1-5) was placed before suture anchoring in 11 patients. Of 19 total previously placed stents, 14 (74%) migrated at a median of 19 days (range 0-391 days), 3 (16%) were found to be in place and were removed endoscopically at a median of 38 days (range 16-52 days), and the remaining 2 were removed at surgery at 4 and 33 days after placement.
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Endoscopic suturing system for prevention of stent migration
The mean ( SD) size for fistula and perforation defects was 16 ( 13) mm. Ten patients underwent 1 or more adjunctive therapies, including endoscopic suturing of the defect before stent placement (n Z 9), over-theendoscope clip (Ovesco Endoscopy, Tubingen, Germany) placement (n Z 2), through-the-endoscope clip placement (n Z 1), and fibrin glue injection (n Z 2) or argon plasma coagulation of the fistulous tract (n Z 1). Endoscopic suturing or clip placement enabled approximation of the edges of the defect, but initial complete closure by using a combination of a percutaneously placed fibrin sealant and endoscopic suturing before stent placement was successful in only 1 patient (patient 12). Because of the extent and chronicity of the fistula in this patient, a fully covered stent was placed despite apparent complete closure by using the fibrin sealant and endoscopic suturing to increase the probability of durable clinical success. Suture-anchored stents included fully covered SEMSs (83%) and partially covered SEMSs (17%), with a mean ( SD) length of 110 ( 25) mm and body diameter of 18 mm (n Z 14) or 23 mm (n Z 4). Endoscopic suturing of SEMSs was performed in the esophagus (n Z 15) and stomach (n Z 3). Eleven of 21 endoscopic suturing procedures (52%) were performed in the outpatient setting, and the remainder in hospitalized patients. Although an esophageal overtube was used in 5 procedures (24%) early in the clinical experience, subsequent procedures were performed without an overtube. All sutures were placed in an interrupted fashion, with a mean ( SD) of 2.6 ( 1) sutures used for stent fixation. The mean ( SD) procedure time, which included stent placement and adjunctive therapies, was 78 ( 40) minutes. As expected, the mean ( SD) procedure time in patients who received adjunctive therapies was significantly longer than in those without additional therapies (102 [ 32] minutes vs 48 [ 27] minutes; P Z .001). Procedure duration also decreased over time as experience in using the device accumulated (P Z .04). The technical success for placement and suture anchoring of stents was 100%. Despite suture fixation, stent migration occurred in 7 of 21 SEMSs (33%) placed (including those placed at subsequent procedures) at a median of 21 days (range 7-40 days). There was no association between the number of anchoring sutures placed and whether the stent migrated, but there was a trend toward increased stent migration despite suture placement when a laser cut stent (Alimaxx-ES; Merit Medical Endotek, South Jordan, Utah) was used in contrast to a braided stent (Wallflex; Boston Scientific Corp, Natick, Mass) (60% vs 15%; P Z .06). Stent migration was managed with stent replacement and repeat suture anchoring in 2 patients (patients 10 and 15), stricture dilation in 2 patients (patients 6 and 14), and endoscopic suturing of the defect in 1 patient (patient 4) (Table 1). Repeat stent placement was not performed in the latter 3 patients because after removal of the migrated stent, the esophageal stricture
appeared mild in severity and amenable to infrequent dilations (patients 6 and 14) or the patient had difficulty tolerating the high esophageal location of the stent (patient 4). Complete clinical success was achieved in 10 patients (56%), with resolution of symptoms and/or underlying disease at a mean ( SD) follow-up of 75 ( 55) days. In this group of patients, 3 died from unrelated causes with the stent still in place at a mean ( SD) of 46 ( 39) days, 1 died from an unrelated cause 3 days after stent removal, 5 had their stents removed as a planned procedure at a mean ( SD) of 75 ( 70) days, and 1 patient had his stent removed during surgical repair of a stent-induced tracheoesophageal fistula. Partial clinical success, with initial symptom improvement but recurrence of symptoms or luminal defect, was achieved in 6 patients (33%), with repeat endoscopic procedures at a mean ( SD) of 24 ( 11) days. In this group of patients, 1 patient (patient 2) required a proximal esophagogastrectomy with end-to-side esophagojejunostomy 9 months later for a persistent gastric fistula after Nissen fundoplication, and 1 patient (patient 10) died from an underlying malignancy after having repeated endoscopic stent placement with suture fixation. The remaining patients were managed with further stricture dilation (n Z 3) and fistula plug placement (n Z 1) (Table 1). Two patients (11%) did not clinically improve with stent placement; 1 required surgical repair of an esophageal perforation, and the other required home parenteral nutrition after further attempts to close a fistula by using endoscopic suturing, and an over-the-endoscope clip failed. Patients with complete clinical success were more likely to have placement of longer and wider SEMSs than those with partial or no success (Table 2). There was a trend toward the use of a partially covered stent and complete clinical success, but the sample size was too small to make any meaningful assessment. Although no adverse events occurred as a direct result of the suturing procedure, a SEMS-related tracheoesophageal fistula occurred in 1 patient (patient 5) at 28 days after SEMS placement and in the setting of ongoing external beam radiotherapy. The tracheoesophageal fistula was not in proximity to the sutures and required surgical repair.
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DISCUSSION Although SEMSs are approved for palliation of malignant obstruction, they are increasingly being used for management of benign diseases, such as refractory strictures, perforations, leaks, and fistulas.1-7 However, stent migration is a major limitation, particularly in conditions where a shelf or luminal constriction for holding the stent is absent. The use of through-the-endoscope clips for stent anchoring is of limited value.9 Placement of partially covered SEMSs may reduce the migration rate as the
Endoscopic suturing system for prevention of stent migration
Fujii et al
TABLE 1. Patient characteristics and outcomes following endoscopic suture fixation of stents
Patient
Age/sex
Prior surgery
Indication for SEMS
Type of SEMS (length 3 body diameter, mm)
1
81/F
Repair of Nissen fundoplication
Gastric fistula
PC-Wallflex* (155 23)
2
44/F
Nissen fundoplication
Gastrocutaneous fistula
FC-Alimaxxy (100 18)
3
80/M
Repair of perforated duodenal ulcer
Enterocolonic fistula
PC-Wallflex* (105 23)
4
17/M
Esophageal atresia s/p multiple surgeries
Tracheoesophageal fistula
5
68/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic dehiscence
FC-WallFlex* (120 18)
6
72/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic stricture
FC-Alimaxxy (100 18)
7
56/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic stricture
FC-WallFlex* (100 18)
8
50/M
–
Esophageal perforation
FC-WallFlex* (100 23)
9
72/M
–
Esophageal stricture
FC-WallFlex* (120 18)
10
55/M
Pancreatic cancer s/p Whipple’s resection
Gastrojejunal anastomotic stricture
FC-WallFlex* (100 18)
11
71/M
–
Esophageal perforation
FC-WallFlex* (120 23)
12
62/M
Billroth II for gastric cancer complicated by ischemic bowel s/p gastrojejunal anastomosis
Chronic jejunocutaneous fistula
13
85/M
Esophageal cancer s/p esophagectomy
Esophagogastric anastomotic stricture
PC-WallFlex* (103 18)
14
32/M 57/M
Esophagogastric anastomotic stricture Esophageal stricture
FC-Alimaxxy (70 18)
15
Esophagectomy for esophageal perforation –
FC-WallFlex* (150 18)
16
41/M
–
Esophageal perforation
FC-WallFlex* (120 18)
17
72/F
–
Esophageal perforation
FC-WallFlex* (120 18)
18
75/F
Esophageal perforation
FC-WallFlex* (120 18)
Failed repair of Boerhaave syndrome
FC-Alimaxxy (70 x 18)
FC-Alimaxxy (70 18)
SEMS, Self-expandable metal stent; F, female; M, male; PC, partially covered; FC, fully covered; s/p, status post; OTSC, over-the-scope clip; –, not applicable. *WallFlex; Boston Scientific Corp, Natick, Mass. yAlimaxx; Merit Medical Endotek, South Jordan, Utah.
uncovered portions of the SEMS embed into tissue, but subsequent stent removal may be problematic and costly if complex retrieval techniques, such as the stent-in-stent method, are required.11
Endoscopic suturing is a promising technique for preventing stent migration, as shown recently in proof-of-principle studies.8,9 Our study demonstrates the utility of this technique in a larger number of patients
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Fujii et al
Endoscopic suturing system for prevention of stent migration
TABLE 1.
Continued
Prior SEMS migration/#
Location/no. of sutures used
SEMS migration despite suture fixation/days
Overstitch-related adverse events
Clinical success
Outcome at last follow-up
–
Esophagus/1
No
No
Complete
Died 5 days later from respiratory failure
–
Esophagus/2
No
No
Partial
Surgery 9 months later with fistula resolution
–
Stomach/2
No
No
Complete
Died 50 days later from ischemic bowel
–
Esophagus/3
Yes/23
No
Partial
Repeat EGD with suture closure of the fistula followed by a repeat EGD with fistula plug and OTSC placement
Yes/1
Esophagus/3
No
No
Complete
Tracheoesophageal fistula induced by SEMS requiring surgical closure
Yes/5
Esophagus/1
Yes/40
No
Partial
Periodic dilations as needed
–
Esophagus/3
No
No
Partial
Periodic dilations as needed
–
Esophagus/3
No
No
Complete
No further therapy
Yes/2
Esophagus/4
No
No
Complete
No further therapy; stent removed 6 months later
Yes/1
Stomach/5
Yes/7
No
Partial
Underwent 2 repeat suture fixations of SEMS but died 2 months later from pancreatic cancer
Yes/1
Esophagus/2
No
No
Complete
Died 5 months later from unknown cause
Stomach/3
No
No
None
Repeat endoscopy with fistula suturing and OTSC placement
Yes/2
Esophagus/2
No
No
Complete
Died 3 months later from colon cancer
No (removed after 27 days for pain) Yes/1
Esophagus/3
Yes/21
No
Partial
Periodic dilations as needed
Esophagus/2
Yes/9
No
Complete
Symptom resolution with repeat stent placement and suture fixation
–
Esophagus/2
No
No
Complete
No further therapy
Yes/1
Esophagus/3
No
No
None
Surgery for closure 5 days later
–
Esophagus/2
No
No
Complete
No further therapy
–
who underwent the procedure for various benign indications, even though our tertiary-care patient cohort presented with complex underlying conditions and a high stent migration rate before suture fixation. Although the
technical success rate was 100%, stent migration occurred in one-third of the procedures in spite of suture fixation. Potential reasons include the use of interrupted rather than running sutures, superficial placement of the stitches
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Endoscopic suturing system for prevention of stent migration
Fujii et al
TABLE 2. Feature comparison between complete and partial/no clinical success following stent placement with suture fixation Complete clinical success (n [ 10)
Partial or no clinical success (n [ 8)
P value
68 (14)
51 (19)
.05
Male
8
6
.80
Underlying malignancy
2
4
.18
Previous surgery
5
7
.09
10 (18)
15 (15)
.65
Prior endoscopic therapy
6
6
.50
Inpatient setting
7
2
.05
Esophageal location of sutures
9
6
.39
Size of defect, mean (SD), mm
16.2 (11.1)
16.3 (16)
.99
Use of adjunctive therapies
6
4
.67
Use of partially covered SEMS
3
0
.08
123 (19)
93 (20)
.005*
6 (60)
8 (100)
.04*
Age, mean (SD), y
Time since previous surgery, mean (SD), mo
Length of SEMS, mean (SD), mm Use of smaller body diameter (18 mm) SEMS, no. (%) SD, Standard deviation; SEMS, self-expandable metal stent. *Significant.
in tissue, and suturing of laser cut stents where the joints may separate if the covering is disrupted. However, suture fixation prevented stent migration in a substantial proportion of patients in whom prior SEMS placement resulted in migration. The migration rate for stents that were anchored was 33% as compared with 74% for stents placed without suture fixation in the same patients. Furthermore, 19 stents were placed before the suture fixation procedure, as opposed to only 3 after the procedure. Therefore, endoscopic suturing to anchor stents potentially can reduce the total number of procedures required and should be given consideration at the index endoscopy for SEMS placement or after the first instance of stent migration. To further enhance the potential cost effectiveness of suture fixation of the SEMS in a patient with a migrated stent, the endoscopist may consider repositioning and suturing the migrated stent rather than placing a new stent, as described by Kantsevoy and Bitner.8 A limitation and bias of our study is that an algorithm was not in place in triaging which patients should undergo endoscopic stent suturing, particularly those who did not have previous stent migration, and the decision was left at the discretion of the endoscopist, based on the perceived risk of migration (eg, prior stent migration or absence of a shelf to hold the stent). After stent anchoring, clinical success was complete and partial in 56% and 33% of procedures, respectively. Clinical success is a function of the stent rather than the suturing procedure per se, and an association between complete clinical success and placement of longer and larger-diameter stents may be inferred from analysis of 792 GASTROINTESTINAL ENDOSCOPY Volume 78, No. 5 : 2013
our data. However, the validity of this finding is unclear because of the small number of patients in each group and the potential confounder of higher migration with laser cut stents. Therefore, further studies that address potential relationships between stent characteristics and the likelihood of clinical success in the setting of benign disease are awaited. Although no adverse events were attributed to the suturing procedure, SEMS placement in a postesophagectomy patient undergoing radiotherapy resulted in a tracheoesophageal fistula at the proximal flange of the stent at a distance from the suture sites. Although it is theoretically possible that a deep suture needle puncture through the esophageal wall could injure surrounding structures, such as the trachea, actuation and position of the curved needle arm of the suturing device can be controlled to avoid a deep tissue “bite.” In conclusion, anchoring of SEMSs by using an endoscopic suturing device was shown to be feasible, safe, and relatively effective at preventing stent migration, particularly in patients with benign conditions in whom stent migration had already occurred.
REFERENCES 1. Salminen P, Gullichsen R, Laine S. Use of self-expandable metal stents for the treatment of esophageal perforations and anastomotic leaks. Surg Endosc 2009;23:1526-30. 2. Thomas T, Abrams KR, Subramanian V, et al. Esophageal stents for benign refractory strictures: a meta-analysis. Endoscopy 2011;43:386-93.
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Osada et al
Wound healing of large mucosal defects
3. van Boeckel PG, Dua KS, Weusten BL, et al. Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-expandable plastic stents for the treatment of benign esophageal ruptures and anastomotic leaks. BMC Gastroenterol 2012;12:19. 4. van Boeckel PG, Sijbring A, Vleggaar FP, et al. Systematic review: temporary stent placement for benign rupture or anastomotic leak of the oesophagus. Aliment Pharmacol Therap 2011;33:1292-301. 5. van Heel NC, Haringsma J, Spaander MC, et al. Short-term esophageal stenting in the management of benign perforations. Am J Gastroenterol 2010;105:1515-20. 6. Dan DT, Gannavarapu B, Lee JG, et al. Removable esophageal stents have poor efficacy for the treatment of refractory benign esophageal strictures (RBES). Dis Esophagus. Epub 2012 Nov 2.
7. Sharma P, Kozarek R. Role of esophageal stents in benign and malignant diseases. Am J Gastroenterol 2010;105:258-73. 8. Kantsevoy SV, Bitner M. Esophageal stent fixation with endoscopic suturing device (with video). Gastrointest Endosc 2012;76:1251-55. 9. Rieder E, Dunst CM, Martinec DV, et al. Endoscopic suture fixation of gastrointestinal stents: proof of biomechanical principles and early clinical experience. Endoscopy 2012;44:1121-26. 10. Bonin EA, Wong Kee Song LM, Gostout ZS, et al. Closure of a persistent esophagopleural fistula assisted by a novel endoscopic suturing system. Endoscopy 2012;44(suppl 2 UCTN):E8-9. 11. Hirdes MM, Siersema PD, Houben MH, et al. Stent-in-stent technique for removal of embedded esophageal self-expanding metal stents. Am J Gastroenterol 2011;106:286-93.
Process of wound healing of large mucosal defect areas that were sutured by using a loop clip–assisted closure technique after endoscopic submucosal dissection of a colorectal tumor Taro Osada, MD, PhD, Naoto Sakamoto, MD, PhD, Hideaki Ritsuno, MD, Takashi Murakami, MD, Hiroya Ueyama, MD, PhD, Tomoyoshi Shibuya, MD, PhD, Kenshi Matsumoto, MD, PhD, Akihito Nagahara, MD, PhD, Tatsuo Ogihara, MD, PhD, Sumio Watanabe, MD, PhD Tokyo, Japan
Endoscopic submucosal dissection (ESD) is indicated for the treatment of large, superficial colorectal tumors.1-4 However, as a result of ESD, large mucosal defect areas are made. Wound healing of artificial defect areas in the large intestine is thought to be influenced by exposure to stool, some types of enterobacteria, and peristaltic movement.5-6 Serious adverse events such as bleeding and perforation are often associated with endoscopic resections, especially when the lesions removed are large.7-8 Endoscopic clips have been used commonly for endoscopic closure of EMR defects to prevent or treat bleeding or perforation.9-10 They can be used when the diameter of the defect is smaller or larger than the width of the open clip. However, when the mucosal defect is larger than the diameter of the open clip, several clips are used. The
Abbreviations: ESD, endoscopic submucosal dissection. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. This work was supported in part by Grant-in-Aid for Scientific Research (C) (No. 23591023 to T.O. and N.S.) from the Ministry of Education, Culture, Sports, Science, and Technology of Japan.
Figure 1. Loop clip. The loop clip consists of an endoscopic clip and looped nylon string. It can be passed through the instrument channel of the endoscope.
Reprint requests: Taro Osada, Department of Gastroenterology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
first clip is attached at 1 of the edges of the defect, the second clip is attached adjacent to the first clip, the third clip is attached adjacent to the second clip, and so on until the defect is closed. However, this method is difficult, cumbersome, and not always feasible. We have designed a new closure device for large mucosal defects, named a loop clip, which makes it easy to close any mucosal defect completely when used with conventional endoscopic clips.11-12 Closure of the mucosal defect by using endoscopic clips is presumed to reduce the risk of adverse
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Copyright ª 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.05.035 Received February 8, 2013. Accepted May 30, 2013. Current affiliations: Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.