Abstract
Background and Aims
A novel gastroduodenal full-thickness resection device system was developed for resection of upper GI tract lesions. In this study, we evaluated the efficacy and safety of the gastroduodenal full-thickness resection device system.
Methods
Consecutive patients who received endoscopic resection of upper GI tract lesions from June 2020 to August 2022 using a gastroduodenal full-thickness resection device were evaluated from 8 U.S. centers. Primary endpoints were technical success and R0 resection. Secondary endpoints were en bloc resection, residual lesions at follow-up endoscopy, and immediate or delayed adverse events.
Results
Forty-four patients (mean age, 60.9 ± 15.8 years) received 45 resections for gastric (35, 80%) and duodenal (9, 20%) lesions. Thirty-four lesions (77%) were subepithelial and 10 (23%) were epithelial lesions. Technical success and en bloc resection were achieved in 43 (96%) and 41 (91%) patients, respectively. Furthermore, R0 resection was achieved in 32 patients (71%), including 24 of 35 (69%) with neoplastic lesions. Pathologic diagnosis included neuroendocrine tumor in 14 patients (32%), GI stromal tumor in 10 (23%), and gastric cancer or high-grade dysplasia in 7 (16%). Minor immediate and delayed bleeding occurred in 17 (38%) and 2 (4%) patients, respectively. One patient had delayed perforation, managed conservatively. On follow-up, 19 of 21 patients (90%) had no residual lesion.
Conclusions
In this multicenter series, the gastroduodenal full-thickness resection device demonstrated high rates of technical success and acceptable rate of R0 resection. Immediate minor bleeding was common, whereas serious adverse events were rare. This gastroduodenal full-thickness resection device should be considered in patients with gastroduodenal subepithelial lesions as an alternative to long-term surveillance.
Upper GI tract neoplastic lesions not amenable to polypectomy are managed with EMR, endoscopic submucosal dissection (ESD), submucosal tunneling endoscopic resection (STER), or endoscopic full-thickness resection (EFTR).1,2 Although EMR and ESD allow endoscopic curative resection of neoplasia that involves the mucosa and possibly submucosa, upper GI tract lesions that involve the muscularis propria cannot be sufficiently or safely resected. STER, on the other hand, allows for effective and safe endoscopic resection of the neoplastic lesions arising from the muscularis propria by using a tunneling technique. However, this technique is typically limited to the mid- and distal esophagus, cardia, lesser curvature of the gastric body, and antrum and requires skilled and experienced operators.3 Freehand EFTR is done first followed by wall defect closure with clips, endoloop, and/or endoscopic suturing, which can be technically challenging for endoscopists.4, 5, 6, 7 For lesions not amenable to resection, current guidelines recommend regular endoscopic surveillance.8,9
Endoscopic resection using a full-thickness resection device (Ovesco Endoscopy, Tübingen, Germany) is an emerging technique that uses sequential deployment of an over-the-scope clip and integrated snare using a tissue grasper (Figure 1, Figure 2, Figure 3, Figure 4, Figure 5). A full-thickness resection device allows for resection of epithelial and subepithelial colonic lesions not amenable to standard resection techniques.10,11
Figure 1.
Resection with the gastroduodenal full-thickness resection device. A, Site is marked. B and C, The gastric subepithelial lesion is identified and grasped with an anchor device. D, The gastric subepithelial lesion is pulled into the applicator cap completely. E, An over-the-scope clip is deployed. F, The gastric subepithelial lesion is resected above the clip.
Figure 2.
Complete setup of the gastroduodenal full-thickness resection device.
Figure 3.
Use of the included guidewire and insertion balloon to navigate past the upper esophageal inlet.
Figure 4.
Left, Prior full-thickness resection device clip. Right, Redesigned over-the-scope clip with less interdental space to reduce the risk of bleeding.
Figure 5.
Resection with the gastroduodenal full-thickness resection device. A, the lesion of interest is identified on EUS. B, The lesion of interest on endoscopy. C, The lesion grasped with forceps. D and E, The lesion is pulled into the applicator cap completely. F, An over-the-scope clip is deployed. Note that the white ring is not seen, indicating deployment of the clip. G, The lesion is resected with the snare. H, The lesion is removed with the endoscope. I, Site after gastroduodenal full-thickness resection.
This novel gastroduodenal full-thickness resection device system for resection of upper GI tract lesions represents the evolution of the original colonic full-thickness resection device system that has been available for a number of years. Endoscopic resection using a colonic full-thickness resection device is increasingly used for resection of colonic subepithelial tumors or epithelial neoplasia extending deeper than the mucosa or associated with submucosal fibrosis, not amenable to standard resection techniques.10, 11, 12 Given the technical ease and high efficacy for the treatment of challenging colonic lesions, the colonic full-thickness resection device system has been used off-label for resection of upper GI tract lesions.13 A new gastroduodenal full-thickness resection device was developed specifically for upper GI tract lesions, is smaller and compatible with a smaller-diameter endoscope (10.5 mm), and includes an optional balloon device and guidewire to aid in the insertion of the scope from the oropharynx into the esophagus (Fig. 3).
A German study evaluating a prototype gastroduodenal full-thickness resection device in 29 patients with subepithelial lesions <15 mm showed a favorable safety profile.11 In response, the over-the-scope clip design was further modified to decrease the interdental space with goals of reducing the risk of bleeding with resection of upper GI tract lesions (Fig. 4). This novel gastroduodenal full-thickness resection device was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for resection of upper GI tract lesions. In this study, we evaluated the safety of the newly designed gastroduodenal full-thickness resection device for resection of upper GI tract lesions by reviewing outcomes from multiple U.S. centers.
Methods
Study design
This multicenter retrospective study included consecutive patients aged >18 years who received EFTR with a gastroduodenal full-thickness resection device (Ovesco Endoscopy) of upper GI tract lesions from June 2020 to August 2022 and were evaluated at 8 U.S. centers since FDA approval of the device. The determination of resectability of lesions was at the discretion of each endoscopist. The maximum recommended lesion size by the device manufacturer is 25 mm for epithelial lesions and 15 mm for subepithelial lesions. The study was approved by the University of California, Irvine before data collection. Centers where EFTR was performed using the gastroduodenal full-thickness resection device were solicited to participate in the study after meeting local institutional review board requirements. Each participating center retrospectively identified and independently collected data including patient characteristics, indications, lesion characteristics, procedure details, adverse events, and post-EFTR clinical course by the end of the data collection period. Afterward, deidentified data were analyzed in the aggregate to evaluate study outcomes.
Data collected were demographic and clinical information including American Society of Anesthesiologists classification, antithrombotic medication use, laboratory values, and all prior endoscopic evaluations (including EUS) to identify the layer of origin, and interventions performed for the evaluation of upper GI tract lesions. Furthermore, detailed data regarding EFTR were collected including the endoscopist performing the procedure, type of anesthesia, size and location of the lesion, adjunctive endoscopic tools required for resection (ie, prOVE CAP [Ovesco Endoscopy], balloon catheter, Tissue Helix fixation device [Apollo, Boston, Mass, USA]), and use of hemostatic interventions. In patients who had multiple procedures, the first procedure at the institution during the study period was considered the index procedure. Medical records were reviewed to characterize the patients before and after EFTR. The final histologic diagnosis was based on available results before and/or after resection.
Gastric full-thickness resection device and procedure
The gastroduodenal full-thickness resection device (Ovesco Endoscopy) is an integrated system designed for full-thickness resection of upper GI tract lesions. It consists of a transparent cap (outer diameter, 19.5 mm) with a modified over-the-scope clip. A tissue grasper and integrated hot snare are located at the rim of the transparent cap with the handle of the snare running on the outer surface of the endoscope under a transparent plastic sheath. The system can be used with an endoscope with a diameter of 10.5 mm. The over-the-scope clip has been modified to have a decreased interdental space to reduce the risk of bleeding and an optional balloon device and guidewire for traversing the upper esophagus.
The target lesion is marked with an electrocautery probe included in the gastroduodenal full-thickness resection device kit. The endoscope is then removed, and the gastroduodenal full-thickness resection device system is mounted onto the endoscope. The target lesion is grasped using the tissue grasper forceps and retracted into the transparent cap where the tissue grasper remains fixed in position. The over-the-scope clip is deployed at the base of the target lesion to encompass the electrocautery marks, and the integrated snare is closed just above the clip where a cutting current is applied to complete the resection. The endoscope is removed with the specimen in the transparent cap. The endoscope is then reinserted to examine the resection site for signs of incomplete resection or adverse events such as bleeding or perforation. A balloon dilator is included in the kit with the option for use in cases of difficult passage.
Study endpoints
Primary endpoints were rates of technical success and histologically complete (R0) resection. Technical success was defined as reaching the target lesion with the gastroduodenal full-thickness resection device, correct application of the gastroduodenal full-thickness resection device clip, and resection with the snare. R0 resection was defined as a histologically complete resection with negative lateral (horizontal) and deep (vertical) margins. R1 resection was defined as a histologically incomplete resection with residual pathology at the resection margins, specified by positive lateral versus deep margin. Rx resection was defined as indeterminate histologic margins by the pathologist. A histopathologic examination was performed at each study center.
Secondary endpoints were en bloc resection, device failure, residual lesion on follow-up endoscopy, and immediate and delayed adverse events. En bloc resection was defined as the absence of macroscopically visible residual lesions after use of the gastroduodenal full-thickness resection device determined by the performing endoscopist, whereas partial endoscopic resection was defined as residual macroscopic margins requiring additional resection. Device failure occurred if the over-the-scope clip, tissue grasper, or integrated snare malfunction led to failure of the gastroduodenal full-thickness resection device. A residual lesion was defined by no evidence of residual lesion on follow-up on endoscopy with or without histologic confirmation.
Adverse events
Adverse events were categorized as immediate or delayed. Immediate adverse events were defined as those that occurred and were identified before the completion of the index procedure. Delayed adverse events were defined by those that occurred or were identified after the conclusion of the index procedure. Adverse events included bleeding (minor, major), perforation, iatrogenic stricture, injury to adjacent organs, leakage, infection, or need for surgery. Minor bleeding was defined as requiring no intervention beyond endoscopic hemostasis or spontaneous hemostasis. Major bleeding was defined as requiring intervention beyond endoscopic hemostasis such as blood product transfusion, vasopressors, prolonged admission, or treatment by interventional radiology or surgery.
Data and statistical analysis
Statistics are presented as mean ± standard deviation or median (range) to analyze continuous or categorical data as appropriate. Univariate analysis using the χ2 test or Fisher exact test identified predictors of the primary endpoint (R0 resection) with a P < .20. Multivariate analysis was performed to evaluate independent predictors of the primary endpoint. A 2-sided P < .05 was considered statistically significant. Statistical analyses were performed in SAS software (version 9.4; SAS Institute Inc, Cary, NC, USA).
Results
Patient population
Between June 2020 and August 2022, 44 patients underwent resection with the gastroduodenal full-thickness resection device for upper GI tract lesions across 8 study centers by 12 endoscopists (Supplementary Table 1, available online at www.igiejournal.org). Forty-five resections were performed with the gastroduodenal full-thickness resection device in 44 patients because 1 patient received 2 EFTR sessions after failing to achieve R0 resection for gastric neuroendocrine tumor (NET) during the index procedure. Mean patient age was 60.9 ± 15.8, 46% of the patients were men, and 57% of patients were American Society of Anesthesiologists class I or II (Table 1). Antithrombotic medications were used in 14 patients (32%), including aspirin alone in 10.
Table 1.
Baseline patient characteristics (n = 44)
| Characteristics | Values |
|---|---|
| Age, y | 60.9 ± 15.8 |
| Male sex | 20 (46) |
| White | 22 (50) |
| Latino | 11 (25) |
| Asian | 6 (14) |
| African American | 5 (11) |
| American Society of Anesthesiologists class | |
| I | 4 (9) |
| II | 21 (48) |
| III | 19 (43) |
| Antithrombotic/anticoagulant use | |
| Aspirin | 10 (22) |
| Dual-antiplatelet therapy | 2 (5) |
| Direct-acting oral anticoagulant | 1 (2) |
| Antiplatelet and anticoagulant | 1 (2) |
| Lesion location | |
| Stomach | 35 (80) |
| Fundus | 3 (9) |
| Cardia | 2 (6) |
| Body | 22 (63) |
| Antrum | 8 (23) |
| Duodenum | 9 (20) |
| First portion | 5 (56) |
| Second portion | 3 (33) |
| Beyond second portion | 1 (11) |
| Lesion size preresection, mm | 11.5 ± 4.4 |
| Indications | |
| Mesenchymal neoplasm, initial | 19 (43) |
| Neuroendocrine tumor, initial | 8 (18) |
| Mesenchymal neoplasm, recurrent or residual | 4 (9) |
| Adenocarcinoma, initial | 3 (7) |
| Neuroendocrine tumor, recurrent or residual | 3 (7) |
| Adenoma, initial | 3 (7) |
| Adenoma, recurrent or residual | 2 (7) |
| Adenocarcinoma, recurrent or residual | 2 (7) |
| Past endoscopic interventions | |
| Mucosal biopsy sampling | 27 (61) |
| EMR | 6 (14) |
| FNA/fine-needle biopsy sampling | 3 (7) |
| Hot snare resection | 2 (5) |
| Endoscopic submucosal dissection | 1 (2) |
Values are mean ± standard deviation of n (%).
Of the 44 patients who received endoscopic resection using the gastroduodenal full-thickness resection device, 35 lesions (80%) were in the stomach and 9 (20%) were in the duodenum. In the stomach, 28 patients received resection for subepithelial lesions and 7 for epithelial lesions. In the duodenum, 6 patients received resection for subepithelial lesions and 3 for epithelial lesions. The mean estimated size of the lesions before resection was 11.5 ± 4.4 mm with a range of 5 to 20 mm. The most common pathologic diagnoses were gastroduodenal NET in 15 (34%), GI stromal tumor (GIST) in 10 (23%), and leiomyoma in 5 (11%) (Table 2).
Table 2.
Final pathologic diagnosis
| Layer | Pathology | No. of cases (%) (n = 45) |
Histologic margin of resection |
|||
|---|---|---|---|---|---|---|
| R0 | R1 | Rx | Not available | |||
| Epithelial | Adenocarcinoma∗ | 4 (9) | 2 | 1 | 0 | 1 |
| Ectopic pancreas | 3 (7) | 3 | 0 | 0 | 0 | |
| Any adenoma with high-grade dysplasia | 3 (7) | 1 | 2 | 0 | 0 | |
| Tubular adenoma | 2 (4) | 0 | 2 | 0 | 0 | |
| Hamartomatous polyp | 1 (2) | 1 | 0 | 0 | 0 | |
| Oxyntic gland neoplasm | 1 (2) | 1 | 0 | 0 | 0 | |
| Calcifying fibrous tumor | 1 (2) | 0 | 1 | 0 | 0 | |
| Subepithelial | Neuroendocrine tumor | 15 (34) | 11 | 3 | 1 | 0 |
| Muscular | GI stromal tumor | 10 (23) | 9 | 1 | 0 | 0 |
| Leiomyoma | 5 (11) | 4 | 1 | 0 | 0 | |
Includes 1 technical failure.
Characteristics of gastroduodenal endoscopic full-thickness resection
During the procedure, general anesthesia was used in 23 patients, monitored anesthesia care in 21, and moderate sedation in 1 (Table 3). Twelve patients (27%) received prophylactic antibiotics per the endoscopists’ discretion. To facilitate the passage of the mounted gastroduodenal full-thickness resection device system, 10 patients required balloon dilation, including 5 at the upper esophageal sphincter, 5 at the lower esophageal sphincter, 3 at the pylorus, and 1 at the duodenal sweep. The remaining 35 patients did not require dilation. Procedures with the gastroduodenal full-thickness resection device were performed with a 2T scope in 30 patients, 1T scope in 13 patients, and pediatric colonoscope in 2 patients. Eight patients required additional use of a tissue helix to facilitate retraction of the lesion after difficulty with grasping forceps. One received salvage resection using the gastroduodenal full-thickness resection device after starting with ESD for a gastric adenoma located in the fundus.
Table 3.
Procedure characteristics
| Characteristics | No. of cases (%) (n = 45)∗ |
|---|---|
| Type of scope | |
| 1T scope | 13 (29) |
| 2T scope | 30 (67) |
| Pediatric colonoscope | 2 (4) |
| Sedation | |
| Conscious sedation | 1 (2) |
| Propofol | 21 (47) |
| General anesthesia | 23 (51) |
| Antibiotics | |
| None | 33 (73) |
| Preprocedure only | 8 (18) |
| Pre- and postprocedure | 4 (9) |
| Accessory | |
| prOVE cap | 9 (20) |
| Tissue helix | 8 (18) |
| Dual J knife | 1 (2) |
| Balloon dilation | |
| Not required | 35 (78) |
| Required | 10 (22) |
One patient received 2 sessions with the gastroduodenal full-thickness resection device.
Technical success of endoscopic full-thickness resection
Of 45 resections performed with the gastroduodenal full-thickness resection device in 44 patients, technical success was achieved in 43 (96%) (Table 4). Two incomplete procedures (4%) resulted from an inability to retract the lesion into the cap despite using the grasping forceps and tissue helix. In the first patient, resection with the gastroduodenal full-thickness resection device was attempted 24 days after receiving ESD for T1 gastric cancer located at the incisura with positive deep margins. In the second patient, a 12-mm gastric GIST was insufficiently retracted into the gastroduodenal full-thickness resection device cap so the colonic full-thickness resection device was used to complete the resection. No case of device failure was observed.
Table 4.
Outcomes of endoscopic resection with the gastroduodenal full-thickness resection device
| Outcomes | No. of cases (n = 45)∗ |
|---|---|
| Technical success | 43 (96) |
| En bloc resection | 41 (91) |
| Partial resection | 2 (4) |
| Incomplete because of lesion characteristic | 2 (4) |
| Device failure | 0 |
| Lesion size postresection, mm | 17.6 ± 5.4 |
| Histologic margin | |
| R0 | 32 (71) |
| R1 | 11 (24) |
| Rx | 1 (2) |
| Not available† | 1 (2) |
| Positive histologic margin for R1 resection | |
| Horizontal | 5 (55) |
| Vertical | 2 (22) |
| Both horizontal and vertical | 2 (18) |
Values are mean ± standard deviation of n (%).
One patient received 2 sessions with the gastroduodenal full-thickness resection device.
Technical failure.
Histologic margin of resection
Of 45 resections performed with the gastroduodenal full-thickness resection device in 44 patients, R0 resection was achieved in 32 (71%). Furthermore, 11 patients (24%) had R1 resection with a positive histologic margin and 1 (2%) had an indeterminate Rx resection. Of the R1 resections, 5 (55%) had positive horizontal margins, 2 (22%) had positive vertical margins, and 2 (22%) had positive horizontal and vertical margins. One (2%) was not included because of the technical failure described earlier. When only 35 resections in 34 patients with proven neoplastic lesions were examined, R0 resection was achieved in 24 (69%). The mean diameter of the resected specimen was 17.6 ± 5.4 mm.
Regarding layer of origin, 14 lesions (32%) originated from the epithelial layer, 15 (34%) from the subepithelial layer, and 15 (34%) from the muscular layer. Pathology within the epithelial layer demonstrated 4 cases of adenocarcinoma (2 R0), 3 of ectopic pancreas (3 R0), and 3 of adenoma with high-grade dysplasia (1 R0). Within the subepithelial layer, 15 lesions (33%) were NETs (11 R0). Within the muscular layer, 10 were GISTs (9 R0) and 5 were leiomyomas (4 R0) (Table 2).
Furthermore, 45 EFTR procedures performed in 44 patients were examined to identify predictors of R0 resection. On univariate analysis, layer of origination of the lesion (subepithelial 77% vs epithelial 40%, P = .11) and location of the lesion (stomach 75% vs duodenum 44%, P = .05) were associated with R0 resection (Table 5). Size of the lesion, prior endoscopic resection, and number of cases were not associated with R0 resection. On multivariate analysis, subepithelial (adjusted odds ratio, 4.8; 95% confidence interval, 1.02-22.2) compared with epithelial lesions were associated with R0 resection (P = .047) but not gastric compared with duodenal lesions (adjusted odds ratio, 3.5; 95% confidence interval, .69-17.1).
Table 5.
Predictors of complete histologic resection (R0)
| Univariate |
Multivariate |
||||
|---|---|---|---|---|---|
| No. of cases/total | Percentage | P value | Adjusted odds ratio (95% confidence interval) | P value | |
| Layer | |||||
| Subepithelial | 27/35 | 77 | .11 | 4.8 (1.021-22.2) | .047 |
| Epithelial | 4/10 | 40 | |||
| Location | |||||
| Stomach | 27/36 | 75 | .05 | 3.5 (.69-17.1) | .13 |
| Duodenum | 4/9 | 44 | |||
| Size | |||||
| >15 mm | 7/11 | 71 | .72 | ||
| <15 mm | 24/34 | 64 | |||
| Prior interventions∗ | |||||
| Yes | 7/10 | 70 | 1.00 | ||
| No | 24/35 | 69 | |||
| Experience | |||||
| ≥3 cases | 10/15 | 67 | .30 | ||
| <3 cases | 21/30 | 70 | |||
Snare polypectomy, EMR, endoscopic submucosal dissection, or full-thickness resection device.
Adverse events
After 45 sessions of EFTR with the gastroduodenal full-thickness resection device, ≥1 adverse event occurred in 20 patients (45%) (Table 6). In accordance with the American Society for Gastrointestinal Endoscopy lexicon,14 18 (40%) were mild and 2 (4%) moderate adverse events.
Table 6.
Adverse events after endoscopic full-thickness resection with the gastroduodenal full-thickness resection device
| Adverse event | No. of cases (%) (n = 45) |
|---|---|
| Immediate minor bleeding | 17 (38%) |
| Immediate major bleeding | 0 |
| Delayed minor bleeding | 1 (2%) |
| Delayed major bleeding | 1 (2%) |
| Perforation∗ | 1 (2%) |
| Organ injury | 0 |
| Stricture | 0 |
| Infection∗ | 1 (2%) |
| Leakage∗ | 1 (2%) |
| Adverse event requiring surgery | 0 |
One patient had delayed perforation, infection, and leakage at the site of resection with the gastroduodenal full-thickness resection device.
Immediate bleeding was reported in 17 patients (39%). All immediate adverse events were immediate minor bleeding treated with bipolar coagulation (16 patients) or epinephrine injection (1 patient) to achieve hemostasis. No difference in immediate bleeding was observed among patients who received or did not receive R0 resection (4/13 [301%] vs 13/32 [41%]; mean difference, –10%; 95% confidence interval, –35 to 21). No other immediate adverse events, such as perforation, stricture, or injury to adjacent organs, occurred.
Two patients (4%) developed delayed bleeding. One patient experienced delayed minor bleeding 3 days after the procedure that required hospitalization for observation but did not require transfusions. Another patient developed major bleeding 2 days after the procedure requiring endoscopic evaluation without hemostatic intervention. One patient (2%) with rheumatoid arthritis on corticosteroids developed a delayed perforation 6 days after an uneventful EFTR. After presenting with abdominal pain, cross-sectional imaging demonstrated a contained perforation with focal air adjacent to the over-the-scope clip. On endoscopy, the over-the-scope clip was partially intact over the resection site without visualization of perforation. After the over-the-scope clip was removed and the site was sutured endoscopically, the patient was discharged on antibiotics and oral diet after 5 days of hospitalization.
Clinical course and follow-up
After completion of the index procedure, 7 patients (16%) were hospitalized for a median of 1 day (range, 1-6) for pain or concern for bleeding. Twenty-four patients (55%) completed follow-up endoscopy at a median of 148 days from EFTR using gastroduodenal full-thickness resection device resection (Table 7). The remaining patients had yet to schedule an endoscopic follow-up at the time of the study completion. Two of these patients (8%) had residual or recurrent lesions on endoscopic examination and biopsy sampling. The gastroduodenal full-thickness resection device clip was still in place in 12 patients (50%). Twenty-one of these patients (88%) underwent biopsy sampling of the gastroduodenal full-thickness resection device site. Nineteen patients (90%) did not have any residual or recurrent lesion on endoscopic examination and biopsy sampling. One patient received a second resection with the gastroduodenal full-thickness resection device for a gastric NET without evidence of residual lesion on the final endoscopic examination. One patient (5%) with a 2-cm adenoma with high-grade dysplasia located in the distal duodenum is planned to receive follow-up endoscopy. The patient who experienced technical failure died postoperatively after receiving surgery for gastric cancer.
Table 7.
Follow-up endoscopy and biopsy sampling (n = 24)
| Values | |
|---|---|
| Mean follow-up endoscopy from index, days | 148 |
| Gastroduodenal full-thickness resection device clip in place | 12 (50) |
| Residual lesion on endoscopy | 2 (8) |
| Biopsy sampling result | 21 (88) |
| Normal tissue | 12 (57) |
| Scar tissue/fibrosis | 7 (33) |
| Neuroendocrine tumor | 1 (5) |
| Adenoma with high-grade dysplasia | 1 (5) |
Values are n (%) unless otherwise defined.
Discussion
This U.S. multicenter study of 44 patients evaluated the efficacy and safety of endoscopic resection using the gastroduodenal full-thickness resection device, including 34 (77%) with subepithelial lesions and 9 (20%) with duodenal lesions. The most common lesions were NET and gastric GIST, consistent with the epidemiology of gastric GIST being the most common mesenchymal tumor in the GI tract.15,16 Technical success was achieved in 96%, en bloc resection in 91%, and complete histologic resection (R0) in 71% during the index procedure, consistent with outcomes observed in studies evaluating resection of gastroduodenal lesions with a colonic gastroduodenal full-thickness resection device or prototypes of the gastroduodenal full-thickness resection device.11,13 Minor immediate and delayed bleeding occurred in 38% and 4% of patients, respectively. One patient developed a mild delayed perforation managed without surgery.
The gastroduodenal full-thickness resection device may be an efficacious technique for complete and early endoscopic resection of small foregut subepithelial lesions.16, 17, 18, 19 Current guidelines on the management of subepithelial lesions vary and depend on size, lesion location, endoscopic findings, EUS findings, and histology.8,20, 21, 22, 23, 24 The recommendation is to resect gastric GISTs >2 cm and all nongastric GISTs. However, for gastric GISTs <2 cm, there is insufficient evidence to recommend resection versus surveillance. Some guidelines recommend resection of all small GISTs (including gastric GISTs) <2 cm because all GISTs have some malignant potential; approximately 20% to 25% of gastric GISTs and 40% to 50% of small-bowel GISTs are malignant at the time of diagnosis.25, 26, 27 Some guidelines recommend resection of gastric GISTs <2 cm only if they carry high-risk EUS features (ie, irregular borders, cystic spaces, ulceration, echogenic foci, or heterogeneity).27 Histologic diagnosis of gastric GISTs <2 cm in size without high-risk EUS features is challenging given the marginal accuracy of EUS-guided FNA or fine-needle biopsy sampling (37%-89%) or bite-on-bite biopsy sampling (28%) requiring resection or EUS surveillance every 6 to 12 months.16,28, 29, 30 Other guidelines recommend EUS surveillance every 3 months to 2 years until the lesions become large enough for endoscopic or surgical resection.16,17 Use of the gastroduodenal full-thickness resection device for upper GI tract subepithelial lesions can provide an accurate diagnosis and obviate the need for continued endoscopic surveillance, which may incur undue healthcare expenses and patient anxiety.18
Moreover, the gastroduodenal full-thickness resection device demonstrated an acceptable safety profile with a low risk of major adverse events as compared with advanced endoscopic resection techniques for upper GI tract lesions including submucosal dissection and resection (ie, ESD for epithelial lesions, STER).31, 32, 33 High incidences of perforation of 6% and 14% have been observed with ESD and STER, respectively.31,33 In comparison, the gastroduodenal full-thickness resection device used in this study demonstrated 38% of patients developing immediate minor bleeding required thermocoagulation or epinephrine injection. One patient developed delayed minor bleeding and delayed major bleeding. Although no immediate perforation or injuries to adjacent organs were observed, 1 patient on long-term corticosteroids, a known risk factor for postoperative leaks, developed a contained perforation not requiring surgical intervention.34 The low rate of perforation using the gastroduodenal full-thickness resection device is consistent with prior studies using a colonic full-thickness resection device in upper GI tract lesions and an earlier model of a gastroduodenal full-thickness resection device.11,13
The low risk of major adverse events highlights the technical ease of EFTR with the gastroduodenal full-thickness resection device as compared with ESD and STER.35 A recent systematic review of studies performed in Asia reported a low incidence (1.1%) of major adverse events for freehand EFTR without the use of the gastroduodenal full-thickness resection device for gastric subepithelial lesions.36 Although promising, freehand EFTR is an advanced resection technique requiring specialized training and experience, thus limiting generalizability in most settings. That said, it should be emphasized that a full-thickness resection device should be used for therapeutic purposes, and its use for solely diagnostic purposes may not be appropriate. If the lesion size is amenable, it is easier and more efficient to use the gastroduodenal full-thickness resection device because it addresses resection and closure at once. Appropriate technical training, careful selection of subepithelial lesions based on histology, selection of appropriate procedural indications, and a thorough preprocedural workup are critical before using the gastroduodenal full-thickness resection device.
Our results also highlight the potential role of the gastroduodenal full-thickness resection device for resection of duodenal epithelial lesions. Endoscopic resection of epithelial lesions in the duodenum with EMR or ESD carries technical challenges and a high risk of perforation compared with gastric lesions. Despite concerns of difficulty intubating the duodenum with a 19.5-mm cap through the pylorus, technical success was achieved in all 9 patients including 4 who had lesions located distal to the duodenal sweep. Although limited by small sample size, no difference in R0 resection was observed between gastric and duodenal lesions in our study.
Complete histologic resection (R0) rates were modest. However, the outcomes may have been affected by multiple conditions such as lesion size and experience. Lesions may have been too large or had characteristics that made it difficult to pull them into the cap. Interestingly, 4 of 6 patients (66%) who failed to achieve R0 resection had no residual lesion detected during follow-up endoscopic examination and biopsy sampling. Although unclear, additional therapy on the resection margin may have occurred related to mechanical necrosis of the tissue caused by the over-the-scope clip. Given the recent FDA approval and because it is a novel device, the experience between endoscopists will vary, leading to a range of experienced and less-experienced endoscopists. These reported cases are the first done by these endoscopists. Our R0 resection rate was comparable with 2 prior studies. One study used a colonic full-thickness resection device in the upper GI tract with an R0 resection rate of 68%,13 whereas the other study used the prototype gastroduodenal full-thickness resection device and achieved an R0 resection rate of 76%.11 Although complete histologic resection appeared to be lower compared with other advanced resection techniques (ie, ESD, STER, and freehand EFTR), the application of the gastroduodenal full-thickness resection device may be a promising treatment option with careful lesion selection given the high rate of technical success compared with standard resection techniques (ie, EMR or snare resection) and excellent safety profile.
Our preliminary results suggest that the gastroduodenal full-thickness resection device may be more effective for resection of gastric subepithelial lesions but should be used with caution in patients with epithelial or duodenal lesions. Although unclear, improved patient selection, additional refinement of technique, and more extensive training for endoscopists may improve R0 resection rates.
Limitations of this study include the retrospective design susceptible to bias and small sample size precluding a robust analysis evaluating predictors of study endpoints. Follow-up endoscopy was also not consistently performed given the limited follow-up. We did not investigate if and when antithrombotic and antiplatelet agents were held in anticipation of endoscopic resection using the gastroduodenal full-thickness resection device. Finally, there are no established guidelines regarding prophylactic antibiotic use in anticipation of resection with the gastroduodenal full-thickness resection device; therefore, antibiotic use was at the endoscopists’ discretion. More studies will need to be done to investigate the appropriate timing of anticoagulant use and the utility and efficacy of prophylactic antibiotic use with the gastroduodenal full-thickness resection device.
In conclusion, the gastroduodenal full-thickness resection device demonstrated high rates of technical success and acceptable rate of R0 resection in this multicenter series. Immediate minor bleeding was common and easily treated, whereas serious adverse events were rare. The gastroduodenal full-thickness resection device may allow for technical ease, low procedural morbidity, potential reduction in healthcare utilization, and widespread accessibility compared with standard EFTR or ESD type techniques available only at expert centers. Therefore, the gastroduodenal full-thickness resection device should be considered in select patients with gastric or duodenal subepithelial lesions as an alternative to long-term surveillance.
Disclosure
The following author disclosed financial relationships: J. B. Samarasena: Speaker for Ovesco; consultant for Olympus, Neptune Medical, Boston Scientific, Steris, and Applied Medical. All other authors disclosed no financial relationships.
Supplementary data
References
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