Recent developments have expanded the frontier of interventional endoscopy toward more extended resections following surgical principles. This article presents two new device-assisted techniques for endoscopic full-thickness resection in the upper and lower gastrointestinal tract. Both methods are nonexposure techniques avoiding exposure of gastrointestinal contents to the peritoneal cavity by a “close first–cut later” principle. The full-thickness resection device is a novel over-the-scope device designed for clip-assisted full-thickness resection of colorectal lesions. Endoscopic full-thickness resection of gastric subepithelial tumors can be performed after placing transmural sutures underneath the tumor with a suturing device originally designed for endoscopic antireflux therapy.
Key points
- •
EFTR after deployment of full-thickness sutures offers a new and effective nonexposure approach for endoscopic resection of subepithelial gastric tumors.
- •
The novel over-the-scope FTR device is a powerful tool for EFTR of colorectal lesions. The indications for this device may be expanded to include duodenal resections in the future.
- •
Both techniques may reduce the risk of perforation and subsequent infection or exposure of the peritoneal cavity to luminal contents including neoplastic cells by a “close first – cut later” approach. Further data are needed to confirm this hypothesis.
Video content accompanies this article at www.giendo.theclinics.com
Introduction
In most cases subepithelial tumors (SETs) of the gastrointestinal (GI) tract are coincidental findings in routine endoscopy. Although endoscopic ultrasound (EUS) with or without fine-needle aspiration provides essential hints on the nature of such tumors, a definitive diagnosis often cannot be obtained. Particularly if the lesion is suspicious for a gastrointestinal stromal tumor (GIST), endoscopic resection is helpful for the acquisition of a definitive histologic diagnosis and risk stratification. Moreover a histologically confirmed complete resection may spare the necessity of further interventions. Because GISTs often arise from or infiltrate deep into the muscularis propria, endoscopic resection of such tumors with conventional techniques naturally results in or at least harbors a significant risk of GI wall perforation. Therefore secure endoscopic closure techniques are mandatory. There are two possible strategies: the tumor is resected first and defect closure is performed in a second step; or a perforation is prevented by creating serosa-to-serosa apposition underneath the tumor before resection. This article presents two techniques using this “close first–cut later” principle, using a suturing device and a novel over-the-scope device.
Introduction
In most cases subepithelial tumors (SETs) of the gastrointestinal (GI) tract are coincidental findings in routine endoscopy. Although endoscopic ultrasound (EUS) with or without fine-needle aspiration provides essential hints on the nature of such tumors, a definitive diagnosis often cannot be obtained. Particularly if the lesion is suspicious for a gastrointestinal stromal tumor (GIST), endoscopic resection is helpful for the acquisition of a definitive histologic diagnosis and risk stratification. Moreover a histologically confirmed complete resection may spare the necessity of further interventions. Because GISTs often arise from or infiltrate deep into the muscularis propria, endoscopic resection of such tumors with conventional techniques naturally results in or at least harbors a significant risk of GI wall perforation. Therefore secure endoscopic closure techniques are mandatory. There are two possible strategies: the tumor is resected first and defect closure is performed in a second step; or a perforation is prevented by creating serosa-to-serosa apposition underneath the tumor before resection. This article presents two techniques using this “close first–cut later” principle, using a suturing device and a novel over-the-scope device.
Endoscopic full-thickness resection of gastric subepithelial tumors using the GERDX suturing device
Indications/Contraindications
For SETs larger than 2 cm that are known GISTs or have EUS morphology suspicious for a GIST resection is recommended by international guidelines. Whether SETs smaller than 2 cm that are suspected of being GISTs should be resected or periodically observed remains controversial. Current National Comprehensive Cancer Network guidelines allow periodic follow-up if no high-risk morphology is detected on EUS. Molecular and pathologic analysis of GISTs less than 2 cm showed characteristics of benign behavior. However, there was a dramatic increase in mitotic activity for GISTs greater than 1 cm compared with smaller tumors. Therefore, resection of GISTs greater than 1 cm could be reasonable. Additionally there may be many patients preferring resection to life-long periodic endoscopic follow-up. Therefore a case-by-case decision is needed in cases with GISTs less than 2 cm. Possible indications and contraindications for endoscopic full-thickness resection (EFTR) after transmural suturing are listed in Table 1 . Performing EUS before EFTR is essential to determine exact tumor size, extramural growth, and regional lymph node status. Furthermore EUS can reliably distinguish lipomas (hyperechoic homogeneous lesions) from potentially malignant lesions. Because of the dimensions of the suturing device its use is limited to gastric lesions.
| Indications | Contraindications |
|---|---|
| Tumor size >35 mm |
| Symptomatic SET | Large extramural tumor component |
| Signs of systemic spread (eg, suspect locoregional lymphatic nodes, ascites) | |
| History of gastric and/or esophageal surgery or stenosis, that impedes the insertion of the EFTR device |
Recently our group published a retrospective case series of 31 patients who underwent EFTR of gastric SETs. Within this trial tumor sizes up to 40 mm could be resected successfully. Because difficulty to place full-thickness sutures underneath SETs increases with tumor size and thus leads to increased perforation risk we do not recommend resection of tumors larger than 35 mm in diameter with this method.
Device, Preprocedure Preparation
All patients receive a single-shot antibiotic therapy with intravenous ceftriaxone or ciprofloxacine during the procedure or within 4 hours after the procedure. The following devices have to be prepared:
- •
The GERDX device (G-Surg, Seeon, Germany), loaded with resorbable, pretied 4-mm sutures and modified expanded polytetrafluoroethylene pledgets (delivered by G-Surg with the device) ( Figs. 1–3 ). Loading of the pledgets and sutures in the arms of the device is shown in Fig. 4 .
Fig. 1
The GERDX device.
( Courtesy of G-Surg, Seeon, Germany, with permission.)
Fig. 2
Tip of the GERDX device with tissue retractor between the arms.
( Courtesy of G-Surg, Seeon, Germany, with permission.)
Fig. 3
The handle of the GERDX device. (A) Slide control to open and close arms of the device. (B) Channel for 5.8-mm videogastroscope. (C) Wire of the tissue retractor. (D) Handwheel for tip angulation.
( Courtesy of G-Surg, Seeon, Germany, with permission.)
Fig. 4
( A ) Arm loaded with expanded polytetrafluoroethylene pledget, needle, and pretied suture. ( B ) Opposing arm loaded with expanded polytetrafluoroethylene pledget.
( Courtesy of G-Surg, Seeon, Germany, with permission.)
- •
One or two additional pledgets with sutures should be prepared
- •
5.8-mm videogastroscope
- •
Guidewire
- •
Electrocautery polypectomy snare
Patient positioning
The patient is positioned in left lateral position. Interventions are generally done under deep sedation with propofol and/or midazolam. General anesthesia with endotracheal intubation usually is not necessary. Monitoring of blood pressure, heart rate, and oxygen saturation is mandatory.
Approach
This technique aims at the resection of lesions after application of transmural sutures to secure wall patency and avoiding exposure of the peritoneal cavity to luminal contents. The sutures used for this indication are resorbable (in contrast to the nonresorbable sutures used in the endoscopic antireflux procedure for which this device was originally conceived).
Procedure
- 1.
A guidewire is placed in the gastric antrum. The GERDX device is advanced into the gastric corpus over the wire. To visualize the suturing procedure a 5.8-mm videogastroscope is advanced through the accessory channel of the device by a second endoscopist and the device is advanced to the lesion in either retroflex or straight position depending on tumor localization ( Fig. 6 A).
- 2.
After opening of the arms of the suturing device (hydraulic mechanism), the tissue retractor is advanced and screwed into the gastric wall at the margin of the tumor. The gastric wall is then retracted into the arms of the suturing device.
- 3.
The arms of the device (preloaded with the previously mentioned pledgets and resorbable sutures) are closed and a full-thickness polytetrafluoroethylene pledgeted suture is placed underneath the tumor to create a serosa-to-serosa apposition ( Fig. 6 C).
- 4.
Steps 1 to 3 are repeated to create an additional suture at the opposing side of the first suture until an intraluminal pseudopolyp has been created ( Figs. 5 A and 6 C ). For each suturing process the GERDX device has to be loaded with new pledgets and sutures and inserted again. Usually two full-thickness sutures are sufficient for a tightly apposed gastric wall plication. If necessary, additional sutures may be deployed. In case of uncertainty, EUS may be performed before resection to confirm inclusion of the entire tumor within the inverted plication of the gastric wall ( Fig. 6 D).
Fig. 5
Schematic illustration of transmural suturing. ( A ) Full-thickness suture with serosa-to-serosa apposition underneath SET. ( B ) After resection GI wall patency is secured by the suture.
Fig. 6
( A ) Endoscopic view of SET before resection. ( B ) EUS of the GIST. ( C ) Application of transmural sutures underneath the tumor. ( D ) EUS showing correctly placed sutures. ( E ) Inspection of resection site (two transmural sutures, three clips). ( F ) EUS of resection site to confirm lack of residual tumor. Arrows , place of sutures.
( Adapted from von Renteln D, Schmidt A, Riecken B, et al. Gastric full-thickness suturing during EMR and for treatment of gastric-wall defects(with video). Gastrointest Endosc 2008;67:738–44; with permission.)
- 5.
The pseudopolyp is resected using a monofilament snare above the full-thickness sutures and below the SET ( Fig. 5 B).
- 6.
Afterward inspection of the resection site is mandatory. If necessary, clips are added to close small dehiscences ( Fig. 6 E). Endoscopic hemostasis may be needed in case of bleeding.
- 7.
Subsequently the tumor is retrieved from the stomach for histologic analysis. EUS is performed immediately postresection to confirm complete tumor resection ( Fig. 6 F).
Adverse Events and Management
The most common adverse event is bleeding at the resection site. Furthermore, perforations of the gastric wall can occur if suture position was not correct or if resection was performed underneath the sutures. Table 2 provides an overview of all adverse events having occurred in our experience. All adverse events could be successfully managed endoscopically. Notably all perforations (N = 3) were detected immediately and closed by deploying another transmural suture with the suturing device, thus qualifying the suturing device for complication management. Bleeding is handled with standard endoscopic strategies, such as the application of clips and/or injection of diluted epinephrine.
| Adverse Events | Rate of Adverse Event |
|---|---|
| Bleeding | 12/31 (38.7%) |
| Perforation | 3/31 (9.6%) |
| Need for surgery | 0/31 (0%) |
Postprocedure Care
Monitoring is continued in a recovery room until the patient is awake and protective reflexes are intact. Standard-dose proton pump inhibitors should be administered for a week. Monitoring red blood count is reasonable. After a fasting period of 24 hours return to normal diet is adapted to patient’s symptoms.
Follow-up and Clinical Implications
Because the procedure is not yet widely used, currently there are no international standards for follow-up. Follow-up after histologically confirmed complete tumor resection depends on the histologic diagnosis of the resected specimen and may be done according to the flow chart in Fig. 7 . Incomplete resection of a GIST should be followed by endoscopic or surgical reresection. Incompletely resected benign SETs may be monitored endoscopically every 1 to 2 years. If no progression or macroscopic recurrence is detected follow-up can be stopped. A histologic diagnosis of GIST requires a subsequent analysis of the mitotic rate and classification according to the Miettinen risk score. Imatinib (Gleevec; Novartis, Basel, Switzerland) therapy should be started for intermediate- or high-risk scores.
Related posts:
The New NOTES Expands Interventional Endoscopy
The New NOTES: More “E” and Less “S” Leads to Success!
Submucosal Tunneling Endoscopic Resection (STER) and Other Novel Applications of Submucosal Tunneling in Humans
Endoscopic Full-thickness Resection (EFTR) for Gastrointestinal Subepithelial Tumors
New NOTES Clinical Training and Program Development
Pre-clinical Training for New Notes Procedures
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
