Published online Oct 16, 2025. doi: 10.4253/wjge.v17.i10.107840
Revised: May 25, 2025
Accepted: September 2, 2025
Published online: October 16, 2025
Processing time: 201 Days and 8.3 Hours
Endoscopic submucosal dissection (ESD) has emerged as a safe and sufficient method of treatment of superficial lesions in the gastrointestinal (GI) tract. Advances in endoscopic closure techniques have developed alongside impro
Core Tip: Certain resection sites after advanced endoscopic procedures should be considered for endoscopic closure. The choice of closure technique depends on defect size, location, tension, anatomy, cost, and clinician’s proficiency with the device. Traditional techniques like through-the-scope clips and over-the-scope clips are reliable for small to medium defects. Innovative solutions such as the X-TackTM HeliX system, OverstitchTM system, and MANTISTM Clip address larger or high-tension defects. endoscopic hand suturing and OverstitchTM system mimic surgical suturing, offering precise and durable closures for large or irregular defects, though it requires significant operator expertise and time. Combined techniques extend the possibilities for sufficient endoscopic closure.
- Citation: Spychalski M, Orzeszko Z, Kasprzyk P. Advancements in endoscopic closure: Embracing a new era of managing complications and postprocedural defects after endoscopic submucosal dissection. World J Gastrointest Endosc 2025; 17(10): 107840
- URL: https://www.wjgnet.com/1948-5190/full/v17/i10/107840.htm
- DOI: https://dx.doi.org/10.4253/wjge.v17.i10.107840
Endoscopic submucosal dissection (ESD) has emerged as a safe and sufficient technique in the management of gastrointestinal (GI) neoplasms. The remarkable results have facilitated its widespread adoption globally. For some indications, ESD demonstrated favorable outcomes when compared to endoscopic mucosal resection (EMR)[1-4] and showed efficacy comparable to that of transanal surgery for rectal lesions[5-7]. The significance of ESD in the contemporary management of early GI cancers is underscored by the latest guidelines from the European Society for GI Endoscopy (ESGE)[8] and the Japan GI Endoscopy Society[9,10]. The Japanese Gastric Cancer Association has established clear criteria for lesions that qualify for endoscopic treatment, categorizing them into lesions of absolute and expanded indication. According to these guidelines, differentiated tumors can be considered for endoscopic resection regardless of size as long as there is no ulceration or signs of invasion beyond T1a. This outlines the potential for extensive ESDs in the treatment of early-stage cancer[11]. ESGE strongly recommends prophylactic clipping of the mucosal defects after hot snare EMR for large nonpedunculated polyps in the right colon[12]. At the same time, prophylactic closure after ESD is not recommended, except in duodenal ESD and gastric ESD in high-risk patients[13]; however, the recommendation is weak with moderate evidence.
A literature search of PubMed up to March 2025 was performed using the key terms “endoscopic submucosal dissection” AND “closure” OR “endoscopic submucosal dissection” AND “suturing” OR “endoscopic submucosal dissection” and “complications”. The search strategy was divided into esophagus, stomach, duodenum, and colorectum.
Although ESD is considered a minimally invasive procedure, it may result in potential complications, which can vary based on several factors, including the location, size of the lesion, and the presence of fibrosis[14-17]. The most frequently encountered complications are perforation and bleeding, which may occur intraoperatively or in a delayed manner (Table 1). Immediate complications are typically identified and managed during the procedure, while delayed complications require prompt recognition to facilitate timely intervention. Urgent endoscopic treatment should be considered; however surgical intervention may be necessary[18]. Management should be tailored according to the location and severity of the complication, as well as the endoscopist’s experience, the patient’s comorbidities, and general health.
Given the possibility of effective endoscopic management of most complications, advances in endoscopic closure techniques have developed alongside improvements in resection methods. Recent innovations, such as endoscopic hand suturing (EHS) and new through-the-scope clips (TTSCs) and systems, are transforming the field. Along with new devices, the combined methods of closure were developed. Embracing these new techniques can lead to enhanced recovery and reduced complications, marking an important milestone in medical practice. In fact, the ESGE recommends against routine prophylactic closure of the ESD defect, except in duodenal ESD; however, endoscopic closure is strongly advised for immediate perforations[13]. The most common postprocedural complications following ESD are delayed bleeding, delayed perforation, and stricture formation. According to recent literature, properly managing the post-ESD defect may reduce the risk of these complications.
Endoscopists should understand the risks of ESD, be familiar with currently available closure devices, and gain the skills necessary to treat intraprocedural and delayed complications. Complete closure of a post-ESD site may be considered in certain circumstances based on patient factors, procedural factors, and the location of the lesion[19].
Intraprocedural bleeding is common, usually mild, and may be treated with a standard electrosurgical knife or coagulation forceps. The bleeding points should be precisely coagulated to avoid excessive thermal damage. These events rarely interfere with the completion of ESD; therefore, they are considered incidents, not adverse events[20]. Nevertheless, in some cases, immediate bleeding may be severe and require additional management. In these circumstances, certain utilities may provide hemostasis, like TTSCs, adrenaline injection, over-the-scope clip (OTSC) or hemostatic powder[21]. If hemoclips are needed, it is preferable to prepare the space around the bleeding vessel to secure the area for further dissection. In cases of failure of endoscopic hemostasis, radiologic embolization can be used. If first-line treatment is unsuccessful or in case of hemodynamic compromise, urgent surgery may be necessary[13].
Delayed bleeding is defined as bleeding that occurs in 4 weeks after the procedure. The risk of delayed bleeding after ESD varies in different tumor locations. Initial management should focus on resuscitation, triage, and observation or preparation for endoscopy[21,22].
Esophageal ESD: In esophageal ESDs, it is estimated at 0%-12.0%, with specific risk factors identified (Table 2), with reports from Japan showing the lowest rates (0%-0.8%)[23-27]. Neither proton pump inhibitors (PPIs) nor vonoprazan did not interfere with that risk[28]. Although PPI administration is suggested by ESGE before esophageal ESD, postprocedural administration applies only to junctional ESD[13].
Ref. | Country of origin | Intraoperative perforation rate | Delayed bleeding rate | Stricture rate |
Tsujii et al[23] | Japan | 5.2% | 0% | 7.1% |
Risk factors: Early treatment periods, low volume institutions | Risk factor: Circumferencial lesion | |||
Yang et al[24] | United States | 2.2% | 6.5% | - |
Iizuka et al[25] | Japan | 1.2 vs 1.8% | 0 vs 0.8% | 20.8 vs 11% |
Risk factor: Age | ||||
Huang et al[26] | China | - | 12.02% | - |
Risk factors: Hypertension, lesion diameter, submucosal fibrosis, C-reactive protein serum level, albumin serum level | ||||
Ishihara et al[27] | Japan | 1.8% | 0.6% | Risk factors: Tumor location, circumferencial lesion |
Risk factors: Tumor location, low volume institution | ||||
Shi et al[154] | China | - | - | 11.6% |
Risk factors: Depth of invasion above m2, circumferential extension > 75% |
Gastric ESD: Delayed bleeding is relatively common after gastric ESD (4.1%-8.5%)[29-32] (Table 3) and requires administration of high-dose PPIs before and after the procedure and preventive coagulation of visible vessels[33-35]. In patients with ahigh risk of postprocedural bleeding additional prophylactic methods can be considered, such as clipping of major vessels or shielding with polyglycolic acid (PGA) sheets or fibrin glue (FG)[13]. Specific high-risk factors were identified (Table 4) to recognize patients who may benefit from additional closure[32,35-37]. Thus, the ESD Trend from Japan score was developed, which includes 10 variables and classifies patients into four categories with different bleeding risks[38]. On the other hand, post-ESD bleeding was identified as a risk factor for residual disease and recurrence[30].
Ref. | Country of origin | Intraoperative perforation | Delayed bleeding | Stricture risk |
Hatta et al[38] | Japan | - | 4.7%-5.0% | - |
RFs: Chronic kidney disease with hemodialysis, antithrombotic agents (aspirin, P2Y12RA, cilostazol, warfin, DOAC), multiple tumors, tumor size > 30 mm, tumor location in lower third | ||||
Suzuki et al[87] | Japan | 2.3% | 4.4% | - |
Zullo et al[86] | Western countries | 3.1% | 5.8% | - |
Yano et al[32] | Japan | - | 8.5% (7.3% in the first 5 days) | - |
RFs in first 5 days: Tumor location in the distal stomach, expanded indications or non-indicated lesions, a specimen diameter of ≥ 40 mm, and antithrombotic therapy | ||||
Risk factors after 5 days: Tumor location in the proximal stomach, hemodialysis, and antithrombotic therapy | ||||
Okada et al[37] | Japan | - | 4.81% | - |
RFs in first 4 days: Size of the specimen, tumor location in the lower third of the stomach | ||||
Risk factors after 4 days: Size of the specimen, tumor location in the middle third of the stomach, hypertension, high body mass index (≥ 25 kg/m2) | ||||
Miyahara et al[29] | Japan | 3.7% | 6.9% | - |
RFs: Tumor location, massive submucusal invasion, endoscopists’ experience of 100-149 cases and hypertension | RFs: Tumor location, tumor size, and scarred lesion | |||
Toyokawa et al[30] | Japan | 2.4% | 5.0% | - |
RFs: Location in the upper area of the stomach | Risk factors: Age ≥ 80 years, long procedure time | |||
Nam et al[31] | South Korea | - | 4.1% | - |
RFs in the first 24 hours: Age ≤ 65 years, resection size ≥ 30 mm, procedure time ≥ 20 minutes, lower third of the stomach, erosion, clopidogrel use | ||||
RFs after 24 hours: The middle to upper third of the stomach, undifferentiated carcinoma, erosion, high risk of stigma during second-look endoscopy, history of early PEB, clopidogrel use | ||||
Sumiyoshi et al[155] | Japan | - | - | Cardia: 21.3% |
Antrum: 3.2% | ||||
RFs: More than 75% of the circumferential extent (both locations) | ||||
Coda et al[156] | Japan | - | - | Cardia: 17% |
Pyloric: 7% | ||||
RF: Circumferential extent > 75%, longitudinal extent > 5 cm |
Number | Risk factors of postprocedural bleeding after gastric ESD |
1 | Antithrombotic therapy (OR = 1.63) |
2 | Male sex (OR = 1.25) |
3 | Cardiopathy (OR = 1.54) |
4 | Cirrhosis (OR = 1.76) |
5 | Chronic kidney disease (OR = 3.38) |
6 | Tumor size > 20 mm (OR = 2.70) |
7 | Resection size > 30 mm (OR = 2.85) |
8 | Location in the lesser curvature (OR = 1.74) |
9 | Flat/depressed morphology (OR = 1.43) |
10 | Carcinoma histology (OR = 1.46) |
11 | Ulceration (OR = 1.64) |
12 | Procedure duration > 60 minutes (OR = 2.05) |
In addition, vonoprazan, a potassium-competitive acid blocker, is expected to improve the healing of ESD-induced gastric ulcers compared with PPIs[39,40]. Warfarin and direct oral anticoagulants (DOAC) are reported to be the biggest risk factor for post-ESD bleeding[41]. The risk was slightly higher risk with warfarin (12.0% vs 9.9%; P = 0.002), and heparin bridging was associated with an increased risk of bleeding but did not prevent thromboembolism[42-44]. Furthermore, anticoagulants were associated with a high incidence of severe delayed bleeding, and warfarin was identified as the major risk factor [odds ratio (OR) = 6.56; P < 0.05][45]. The overall bleeding risk associated with DOACs is increased (10%-21%), but it varies among different agents[35,45]. Dabigatran was associated with the lowest risk of delayed bleeding among DOACs[46,47]. Switching oral anticoagulants to dabigatran during the perioperative period could be a reasonable option to reduce that risk. On the other hand, a continuation of aspirin is safe in terms of post-ESD bleeding and prevents thrombotic events[48]. Thus, in high-risk procedures, ESGE recommends continuation of aspirin, discontinuation of DOACs for 3 days before and 2-3 days after the procedure, and discontinuation of warfarin for 5 days with heparin bridging to achieve pre-procedural international normalized ratio < 1.5 with restarting on the evening of the procedure[49]. On the other hand, Japan GI Endoscopy Society recommends against discontinuation of any antithrombotic agent in monotherapy. Only one dose of DOACs is skipped on the morning of the procedure to avoid operating during the peak serum level of the DOAC agent. Continued warfarin treatment is suggested in patients with the international normalized ratio within the therapeutic range or a temporary switch to DOAC in those with non-valvular atrial fibrillation[50]. Although the risk of delayed bleeding was increased, the implementation of these guidelines was assessed in clinical practice in Japan and reported as safe and feasible[51-53]. However, these results might not be easily repeated in non-expert facilities.
Duodenal ESD: In duodenal ESDs, the delayed bleeding was reported in 10.0%-18.7%. However, it may drop significantly when the defect closure is well managed and complete (13.9% vs 1.1%, P < 0.001). The factors of increased risk of bleeding were identified as antithrombotic agents (OR = 3.8, 95%CI: 1.0-14.6) and a defect circumference of 1/2 (OR = 6.2, 95%CI: 1.2-30.5, P = 0.029). At the same time, complete mucosal closure was reported as a protective factor (OR = 0.19, 95%CI: 0.038-0.95, P = 0.043)[54]. The implemented methods include TTSCs, OTSC, combined methods (TTSCs + endoloop), and laparoscopic closure[55-58]. Therefore, a routine closure of defects in that location is recommended[13].
Colorectal ESD: The risk of delayed bleeding after colorectal ESD is about 2.1%-8.0%, with a few risk factors identified (Table 5). The major indicators were long operation time, rectal location, and cancer histology[59-61]. Several studies have addressed the effectiveness of defect closure to prevent delayed bleeding. Prophylactic clipping of resection sites after endoscopic removal of large (≥ 2 cm) colorectal lesions using low-power coagulation was reported to reduce the risk of delayed bleeding after EMR, and the preventive effect was most likely limited to locations proximal to splenic flexure[62]. It reduced the risk of delayed bleeding after ESD (1.2% vs 5.5%, P < 0.0001) with no impact on the risk of perforations[63]. For instance, data from a randomized controlled trial demonstrated that endoscopic clip closure of the mucosal defect after EMR of large colon polyps larger than 20 mm reduced the risk of postpolypectomy bleeding (absolute risk difference: 3.6%; 95%CI: 0.7-6.5), and the effect appeared to be restricted to procedures in the proximal colon (absolute risk difference: 6.3%; 95%CI: 2.5-10.1)[62,64]. However, larger defects can be challenging to close using TTSCs, and proximal defects are difficult to reach using over-the-scope (OTS) techniques[65]. Prophylactic clipping after endoscopic resection of polyps smaller than 20 mm has not been shown to reduce the risk of postpolypectomy bleeding[66].
Ref. | Country of origin | Perforation | Delayed bleeding |
Albouys et al[59] | France | - | 8.0% |
Risk factors: Age > 74 years, use of antihrombotics, rectal location, size > 50 mm, ASA score III or IV | |||
Seo et al[60] | South Korea | - | 2.9% |
Risk factors: Tumor location in the rectosigmoid colon, tumor size ≥ 30 mm, use of antiplatelet agents except for aspirin alone | |||
Lim et al[91] | - | 4%-8% | - |
Tanaka et al[157] | - | 4.7% | - |
Kim et al[15] | - | 20.4% risk factors: Tumor size, fibrosis | - |
Saito et al[158] | - | Intraprocedural: 4.9% | - |
Delayed: 0.4% | |||
Risk factor: Tumor size > 5 cm | |||
Akintoye et al[153] | - | Intraprocedural: 4.2% | 2.1% |
Delayed: 0.22% |
Perforations remain a significant intraprocedural incident. The diagnosis may be immediate, early (in 24 hours), or delayed (after 24 hours). The American Gastroenterology Association provides a detailed expert review on managing perforations in the upper and lower GI tract based on endoscopic closure techniques. The endoscopist should be aware that ESD is enlisted as a procedure of increased risk for perforation. Preventive measures like the insufflation of carbon dioxide and a thorough investigation of the resection site should be applied in all procedures. In addition, applying the suitable closure method may prevent delayed complications[67-70].
In case of suspected perforation, the insufflation should be minimized to avoid compartment syndrome. The field needs to be cleared of any luminal content to prevent peritoneal contamination. Immediately diagnosed perforation may be managed endoscopically, when feasible, with the intention of primary closure (Table 6). Immediate clip closure for a minor perforation or muscular layer injury remains critical in the prevention of delayed perforation. Although, in delayed cases, endoscopic methods may still be considered, patients manifesting peritonitis, sepsis, hemodynamic instability, or compromised general condition require immediate surgical intervention[13,71,72].
Location and size | Management/device |
Esophagus, < 2 cm | TTSCs |
OTSCs | |
Esophagus, > 2 cm | Endoscopic suturing |
Stenting with SEMS (only when primary closure is not possible) | |
Stomach, < 2 cm | TTSCs |
OTSCs | |
Stomach, > 2 cm | Endoscopic suturing |
Combined method: TTS clips + endoloop | |
Duodenum (type 2) diagnosed at the time of ERCP | TTSCs |
Consider additionally placing stent (fully covered SEMS) into the bile duct across the ampulla | |
Colon | TTSCs |
OTSCs | |
Endoscopic suturing |
Esophageal ESD: Perforation occurs in 1.2% to 5.2% of esophageal ESDs and the rate increases in procedures that involve more than 75% of the lumen circumference[73-77]. TTSCs and OTSC are well-recognized as effective methods of closing defects up to 2 cm in size. Wider ruptures may be managed with endoscopic suturing. If the visibility is poor or the defect is too large for endoscopic management, placing a fully covered self-expandable metallic stent is an effective method to consider to divert the flow of bowel contents before the closure by secondary intervention[78-81]. Additionally, the effective closure of the large perforation during esophageal ESD was reported with the implementation of the combined closure technique of reopenable-clip over-the-line method (ROLM) described below (section: Combined techniques)[82]. For perforations associated with mediastinal collections, endoluminal vacuum therapy may be an option[78,82,83]. There are reports of successful treatment with a PGA sheet and FG, or even conservative management for small defects[75,84,85].
Gastric ESD: In gastric ESDs the risk of perforation is 2.3%-3.7%[29,86,87]. Applying suction before placing clips provides tighter approximation of the defect. TTSCs are optimal for perforations smaller than 1 cm. For defects 1-2 cm in size, OTSC may be the preferable option. Above that size endoscopic suturing or combined methods are available (TTSCs and endoloop or ROLM)[78,88,89].
Duodenal ESD: The highest perforation rate was reported in the duodenum (17%-39%)[58,87-90]. In that location ESD should be performed only by experts proficient both in resection and mucosal defect closure. Large lateral perforations (type 1) are difficult to manage endoscopically and should be immediately referred for surgery. Periampullary perforation (type 2) recognized at the time of endoscopic retrograde cholangiopancreatography may be treated with TTSCs and placement of fully covered self-expandable metallic stent into the bile duct across the ampulla[78].
Colorectal ESD: The risk of perforation after colorectal ESD was estimated at 4%-8%[91]. Colon perforations during diagnostic colonoscopy are most common in the sigmoid colon, while in therapeutic procedures, there is no dominant location. The rate of iatrogenic perforations was reported as 0.2%, with 68.4% occurring during interventional procedures[92]. Higher risk was noted in patients with active inflammatory bowel disease and on steroids[93]. Endoscopy is the feasible first-line treatment in the majority of cases, and an 81.5% success rate was reported when attempted. The clinical success of the endoscopic approaches is higher in interventional than non-interventional perforations[92]. Colon perforations are responsive to various endoscopic tools such as TTSC, OTSC, and endoscopic suturing if the bowel preparation is good and the patient is stable[78]. However, OTS utilities may be challenging to apply in the right colon, and novel through-the-scope (TTS) utilities may be useful.
Closure devices vary in closure strength, time, and difficulty. Optimal device selection will depend on defect size, location, the viability of the surrounding tissue, and the endoscopist’s expertise (Table 7). Thus, the suturing device achieved the highest closure strength, and the mean procedure time for the suturing device was longer than all of the other devices. When the National Aeronautical and Space Administration Task Load Index score was calculated for endoscopists, indicating the cognitive and external workload during the procedures with different devices, the suturing device and helical system proved to be the most demanding. On the other hand, applying TTSCs OTSC was relatively easy[94]. However, the availability of closure devices varies in different countries. The most common limitation is the significant expense, particularly regarding OTS clips and suturing devices.
Device | Specifications |
TTS clip[78,94] | Intermediate strength |
Fast application but may be challenging in large defects | |
Easy to deliver (beneficial in the right colon and in difficult locations) | |
Good choice in defects smaller that 2-3 cm | |
Alternative and combined methods are available | |
Cost-effectiveness depends on the number of clips used but is usually well maintained | |
OTS clip[78,94,107,159] | Intermediate strength in 15 mm defects |
Low strength in 30 mm defects | |
Medium prolonging of the procedure but its rather easy to apply after proper training | |
The diameter of the tip of the scope is increased with additional device (16.5-21 mm) that has irregular edges - it may cause difficulty in an introduction of the scope through the larynx and strictures of all origins (including radiation) | |
Poor visibility due to bleeding may make the application not possible | |
May lead to stenosis | |
Allows only one attempt to close the defect | |
May inadvertently capture structures beyond the gastrointestinal wall as seen in the reports of unintended inclusion of organs and vessels adjacent to the target site | |
The newly introduced OTSC cutting device (remOVE system; Ovesco) allows for the removal of a deployed OTSC. When cutting OTSC, the electric DC impulses are delivered by a special electric generator connected to the grasping device | |
However, it is important to note that the OTSC cutting device has a 10- to 15-minute warm-up time before it can be used. Therefore, removing a misdeployed OTSC and deploying a second OTSC on the misfired location would entail a significant time lag | |
EHS[78] | Appropriate for defects larger than 2-3 cm |
Feasible in various locations and depths | |
High strength and secure closure | |
Takes more time and is difficult to perform (extensive training is appropriate) | |
Overstitch[94] | High strength and secure closure |
Takes more time and is difficult to perform (extensive training is appropriate) | |
May inadvertently capture structures beyond the gastrointestinal wall as seen in the reports of unintended inclusion of organs and vessels adjacent to the target site | |
Is significantly more expensive than other devices | |
X-tack Helix[94] | Most beneficial in superficial defects smaller than 3 cm, but can be applied in more advances ones |
Low strength | |
Medium prolonging of the procedure | |
Application may be challenging | |
May be removed with fully rotatable rat tooth forceps | |
Cost-effective in specific indications |
TTSCs are a group of devices that are delivered to the procedure site through the working channel, then precisely closed and deployed. The diameter of the devices varies between 2.6 mm and 2.8 mm. The application of TTSCs is a straightforward procedure and is frequently the initial closure method adopted by early-career endoscopists.
Classic clipping: Currently, various types of TTSCs are available on the market. After introducing a reloadable clip system, the first modern pre-loaded TTS was presented in 2002 (QuickClip, Olympus, Tokyo, Japan). In the following years, multiple new devices were marketed with different mechanical properties. Each clip has a unique physical and functional profile, which may be a factor in selection depending on the clinical circumstances, availability and pricing of the clip, and preference of the endoscopist (Table 8)[95]. Also, the indications for TTS use are well established (Table 9).
Clip and brand | Brand | Arms span | Reopening/repositioning | 360 degree rotation | Retention period | MR safety | Additional information |
Resolution™ | Boston Scientific, Marlborough, MA, United States | 11 mm | 5 times | - | 4-8 weeks | + | - |
Resolution™ 360 | 11 mm | 5 times | + | 4-8 weeks | + | Nurse/technitian controlled rotation using control knob and physician controlled rotation using a braided catheter | |
Resolution™ 360 Ultra | 17 mm | 5 times | + | 4-8 weeks | + | ||
QuickClip2™ | Olympus, Tokyo, Japan | 9 mm | No repositioning | + | 9.4 days | Unsafe | - |
QuickClip Pro™ | 11 mm | 5 times | + | 1-2 weeks | Conditional | - | |
Retentia™ | 9 mm/12 mm/16 mm | Unlimited | + | No data (new device) | Conditional | - | |
EZ Clip™ | 7 mm/9.5 mm/11 mm | No repositioning | + | - | Conditional | Reloadable clip applicator | |
Instinct Plus™ Clip | Cook Medical, Bloomington, IN, United States | 16 mm | 5 times | + | 1-3 weeks | Conditional | - |
LOCKADO™ | MicroTech Endoscopy, Micro-Tech, Ann Arbor, Michigan, United States | 8 mm/11 mm/16 mm/(22 mm) | Unlimited | + | Limited data, probably 1-3 weeks | + | Indications: Mucosal and submucosal defects smaller than 30 mm, bleeding ulcers and polyps smaller than 15 mm, luminal perforations smaller than 20 mm in the GI that can be treated without surgery |
SureClip™ | 8 mm/11 mm/16 mm | Unlimited | + | 2-4 weeks | Conditional | A shorter stem | |
EcoClip | 8 mm/11 mm/16 mm | Unlimited | + | 1-2 weeks | Conditional | - | |
DuraClip | Conmed Corporation, Utica, NY, United States | 11 mm/16 mm | Unlimited | + | 1-3 weeks | Conditional | A shorter stem (deployed part is 10 mm long) |
Number | Indications for TTS clips |
1 | Endoscopic marking |
2 | Hemostasis for: Mucosal/sub-mucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm in diameter, diverticula in the colon, prophylactic clipping to reduce the risk of delayed bleeding post lesion resection |
3 | Anchoring to affix jejunal feeding tubes to the wall of the small bowel |
4 | Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion |
5 | As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively |
Novel clips are two-arm devices that allow one to grab the margins of the defect and close it using a handle controlled by an assistant. First, the clips available on the market are all rotatable. The clip’s handle drives the rotation. However, novel clips (Resolution 360TM, Boston Scientific) may be rotated by a physician at the biopsy cap of the scope. The Resolution 360TM, SureClipTM, and Dura ClipTM were able to rotate through the prescribed sequence across all scope configurations. Deployment of the InstinctTM clip and Resolution 360TM clip was successful for gel tissue thicknesses up to 10 mm[95]. Secondly, the clips may be one-drop or repositionable (with limited or unlimited reopening) (Table 8). Also, the majority of available clips are single-use and pre-loaded, but the EZ-clipTM (Olympus, Tokyo, Japan) was developed as a reloadable clip system to reduce costs. Furthermore, one of the main features remains the retention period. The retention after 2-4 weeks varies for different types of clips (Table 8).
In addition, clip closure of large colorectal defects after EMR sometimes results in bumpy scars that are normal on biopsy, called post-EMR scar clip artifacts. It may result from a mucosal elevation with a regular pit pattern or granulation tissue related to the presence of residual clips. It was reported that 31.7%-46.8% previously clipped EMR sites had EMR scar clip artifacts at a median follow-up of 5.2 months. The degree increased to 75.0% when the scars had residual clips. The risk factors for ESTA creation were clipping for prophylaxis of bleeding, female sex, age, and the number of clips placed. Clip artifacts can be consistently distinguished by their endoscopic appearance. If unrecognized, they can be mistaken for residual polyps, leading to unnecessary thermal treatment and potential adverse events[96,97].
Although prophylactic clipping of resection sites after endoscopic removal of large (≥ 2 cm) colorectal lesions may be beneficial, closing large mucosal defects using conventional clips remains technically challenging[65]. To address this issue, novel models and combined techniques were developed.
Origami: Simple clipping of large defects results in mucosa-mucosa closure, which could create a dead space under the mucosa and impair postprocedural healing. The origami method is a novel endoscopic closure technique using a double-layered closure with standard TTSCs. In this method, the muscle layer is initially closed with TTSCs, followed by standard closure of the mucosal layer. It enables the obtaining of robust closure even for large defects in any location[98]. The technique was reported as beneficial after duodenal ESD in defects with a median defect size of 38 mm (range: 26-110). Complete closure was achieved in 96% (27/28), including the largest lesion. The median closure time was 16 minutes[99]. Furthermore, the closure after colorectal ESD was successful in 94% of cases and was fully efficient in the lower rectum[98].
MANTISTM Clip: The MANTISTM Clip is a reopenable, rotatable TTSC designed to close large defects using anchor prongs to grasp tissue securely[100]. Deploying a single MANTISTM Clip at the widest point of the wound enables further closure with standard TTSCs. The grasping arms are equipped with anchor prongs that protect the tissue against slippage despite its tension when mobilized. It is designed to close defects smaller than 30 mm, but the literature provides evidence of complete closure of defects up to 62 mm wide[101]. The MANTISTM Clip was effective for mucosal defect closure after gastric and colorectal ESD, demonstrating high success and sustained closure rates (96.1%-98.4%) with minimal complications. The median closure time was 7-8 minutes[101-105]. The closure is provided in three steps: Anchor, mobilize, and close. First, one edge of the defect is anchored with a clip. Second, the tissue is mobilized and dragged to the opposite edge of the defect. Then, the clip is slowly reopened, and the anchor prongs protect the tissue against slipping. Finally, When the edges are approximated correctly, the clip is closed and deployed. The major limitation of their implementation is that they cost significantly more than standard TTSCs. Also, fixing one side first with too much tension can lead to mucosal tearing. The clip was reported to remain on site 30 days after a gastric ESD[103]. However, due to the recent introduction of the clip, the data on its retention is limited.
The OTS devices are limited by the target location, maneuverability, and need for a scope withdrawal before application. They are installed at the tip of the scope. Obviously, the diameter of the device is larger and requires additional space for the insertion. The use of OTSC after ESD requires performing resection initially with a standard distal attachment, then withdrawal, installing the OTSC, and subsequent insertion of the scope. Thus, proximal defects may be difficult to reach using OTS techniques.
It was pointed out that we should standardize the nomenclature for endoscopic clipping techniques to be consistent. The terms endoscopic TTSCs and OTSC, which refer to through the scope and over the scope, respectively, were suggested as the most precise and avoiding confusion between the technique of OTS devices (clipping or suturing devices) and the OTSC (OTSCÒ, Ovesco Endoscopy AG, Tuebingen, Germany), which is trademarked[106].
Ovesco: The OTSCÒ (OTSC) system by Ovesco Endoscopy AG began to be widely used in endoscopic procedures around 2008. The main components of the device are the cap with a nitinol clip mounted on the end of the endoscope and the hand wheel connected by a thread. Applicator caps come in various sizes to fit different endoscope diameters (8.5 mm and 14 mm). Ovesco clip system effectively closes GI mucosal defects after ESD with an overall clinical success rate and technical success rates of 92.8% and 95.9%, respectively[107]. Full-thickness tissue defects up to 20 mm in the stomach and 30 mm in the colon can be adequately closed with a single OTSCÒ[108].
Currently, the Twin Grasper® is available on the market, expanding the functionality of the Ovesco system. This dual forceps-like tool allows the precise approximation of the two edges of the defect and their traction toward the endoscope lumen before releasing the clip[109]. Complication rates remain low, with an overall rate of 1.7%-2.1%, and the adverse events documented include misplacement, bleeding, and perforation; surgical intervention is rarely required[107,110].
Due to their strong grip and ability to capture a substantial amount of tissue, these clips are more effective than conventional endoscopic clips. They provide long-term closure, which is crucial in cases of perforations. Also, it is suitable not only for perforations but also for fistulas, anastomotic leaks, and GI bleeding management. Nevertheless, Ovesco clips present certain limitations, such as the technical complexity of the application and the lack of repositioning capability. Their deployment requires expertise and precise technique, and once deployed, the clip cannot be repositioned, necessitating careful placement. Application may be difficult in the narrow lumen section within the GI tract.
These results indicate that the Ovesco system reliably closes mucosal defects following ESD when used under appropriate conditions. However, their use requires experience, optimal anatomical conditions, and consideration of cost and potential complications.
Padlock ClipÒ: The Padlock ClipÒ (Aponos Medical Co., Kingston, NH, United States) is an innovative OTS clip designed for endoscopic closure of GI defects and hemostasis. It features a nitinol construction with an 11mm tissue chamber diameter and is delivered via an OTS pod, allowing for easy deployment. The clip provides full-thickness closure, offering strong tissue fixation using peripheral prongs, and operates through suction for tissue engagement[111]. It remains in place for up to three months, providing a durable solution for managing GI perforations and severe hemorrhages. The benefit of Padlock ClipÒ is that it is a simple deployment and that it does not occupy the working channel. However, it has limitations when treating lesions larger than 2 cm and cannot be removed once deployed[112].
Compared to the Ovesco clip, the Padlock ClipÒ offers a different approach, with a 360° closure and a design that avoids blocking the working channel, making it suitable for complex procedures. Both systems have shown promise in managing GI defects, with high rates of technical and clinical success. However, publications on the Padlock ClipÒ are limited, and this tool requires further research[111,113].
EHS: EHS has emerged as a promising modality in endoscopic procedures, particularly after ESD. Recent studies have demonstrated its potential in preventing post-procedural complications. EHS may mitigate the risk of delayed bleeding, improve the healing process, and effectively close a full-wall defect after endoscopic resection[114-116]. Goto et al[69] reported that EHS may prevent postoperative bleeding in patients undergoing gastric ESD while being treated continuously with antithrombotic agents.
The technique of EHS requires facilitating an endoscopic needle-holder and barbed surgical suture. The device is fully operational in one-channel scopes. The needle may be delivered to the suturing site in the distal attachment or through the overtube. In this technique, the needle is held on the side opposite to the tip with the needle holder. The needle is pierced perpendicularly into the tissue at the one side of the wound with an appropriate margin, then driven through the tissue with rotation and grasped at the bottom of the defect. The same steps are repeated on the other side of the wound symmetrically. The depth of the suture may be adjusted according to the procedure, including full-thickness facilitation. Then, the closure is complete, the suture is cut with endoscopic scissors, and the needle is removed in the same way it was delivered. The technique is appropriate for defects larger than 2-3 cm and may be applied to defects of various origins, locations, and depths[117,118]. Although the learning curve is steep and the procedure is challenging, it is beneficial in terms of the precision and the suture’s strength[68,94].
OverStitchTM: The OverStitchTM system (Apollo Endosurgery, Austin, TX, United States) device is a complex endoscopic suturing system. It comes in two modalities: For the double-channel scope (OverStitchTM) and single-channel scopes (OverStitch SxTM)[119]. The device is a suturing tool attached to the endoscope, allowing for the placement of sutures within the GI tract. The system utilizes a specialized needle and thread mechanism to pass sutures through the tissue, creating secure, adjustable stitches. The device provides reliable full-thickness closure and is compatible with double and single-channel endoscopes. It is most commonly used in endoscopic sleeve gastroplasty procedures, and it has shown promise in closing mucosal defects after ESD. Studies report high technical success rates and effective closure of large defects. Also, it allowed for effective closure for risk reduction in high-risk patients such as those on anticoagulants and may promote same-day discharge[120,121].
However, the drawbacks of this technology include its reduced efficacy in anatomically challenging defects, the necessity for specialized training for both the endoscopist and the assistant, and the high cost of the device. Also, the device is expensive, and suturing can be technically challenging. Thus, specialized training is obligatory[122]. Despite its limitations, OverstitchTM appears to be a feasible and safe option for closing defects after ESD in various GI locations[123,124].
The defect closure may be facilitated with combined techniques for sustainable effect and decreased procedural time.
TTSCs and loop (purse-string closure): The first loop and clips technique for the closure of larger post-ESD mucosal defects required a two-channel endoscope and was technically more difficult[125,126]. Thus, the single-channel alternatives were developed using a pre-detached loop and clips [single-channel endoscopic closure technique (SCCT)][127,128]. Initially, the loop is detached and delivered to the site with the first clip or in the outer sheet through the single working channel of the scope. The loop is positioned around the defect, and the first clip is deployed. Subsequently, five metal clips are used to anchor the loop around the edge of the mucosal defect. Then, the loop tail is grasped by a standard or modified J-shaped endoloop hook device and tightened to close the defect like a purse-string suture[128,129]. The SCCT technique is relatively easy and possible in all locations. In a relatively small prospective cohort study, it was reported to take a median of 13.5 minutes (8-20 minutes) with 100% success in case of defects with a median of 28 mm diameter (12-50 mm) with no complications[127,128,130]. The method is relatively cheap when compared to ready-to-use devices. Interestingly, the technique may be used not to close the defect fully but to make it smaller and to apply other techniques, like an OTSC, for definite closure[131].
Clip over the line technique: Clip-over-the-line technique (also ROLM) is an alternative method of defect closure. This technique requires a long nylon suture (line) and reopenable TTSCs. First, a line is tied to the arm of a clip. The clip-and-line is inserted into the working channel of the scope. The clip-and-line is placed on the normal mucosa at the anal margin of the mucosal defect. Subsequently, the end of the line emerging from the accessory channel of the endoscope is threaded through the hole in one arm of a second reopenable clip, which is then inserted into the endoscope and positioned at the other side of the defect. The muscular layer of the mucosal defect is gripped by the tooth of the reopenable clip through which the line has been threaded. The line is continuously tightened to gather both margins of the defect, thereby preventing the clips from becoming buried in the muscle layer. The latter step is repeated towards the oral side, with several additional clips required to close the defect. Finally, the line is cut using a modified locking clip technique or a disposable loop cutter. This technique aims to eliminate submucosal dead space, suppress peristalsis of the muscle layer, and effectively diminish the defect[132].
The technique may be feasible for large defects and was reported as 100% successful in the range between 31-73 mm defects. The median closure time was 30 minutes (range: 14-35 minutes). However, the larger the defect, the more clips were required for closure, ranging from 10 to 93[88].
Furthermore, ROLM was used to close multiple defects after endoscopic full-thickness resections for submucosal lesions in the stomach and a full-thickness defect after ESD for rectal cancer with infiltration of the muscle layer[133,134]. Application of ROLM after gastric procedures facilitated secure full-thickness defect closure, reduced post-procedural abdominal pain, shortened the fasting and hospitalization period compared to SCCT and decreased the risk of bleeding after gastric ESD[132,134]. Although the ROLM method is effective and feasible, the tremendous number of required clips can make the procedure financially ineffective.
X-TackTM system: X-TackTM Endoscopic HeliX tacking system is a ready-to-use single-use device comprising four helix tackers tethered with a single polypropylene suture and a “driver” - tacks’ delivery device. The tacks must be placed in exact order one by one. The device allows for deep submucosal fixation through standard single-channel scopes.
Initially, the first HeliX tack is placed into healthy tissue adjacent to the defect. HeliX tack is detached from the “driver”. Next, HeliX tacks is reloaded on the “driver” and inserted. Up to four HeliX tacks are placed independently around the defect at opposite sites. Tightening of the suture approximates margins for a complete closure or fixation. The suture cinch locks the construct and cuts the excess suture. Since its introduction in 2020, several studies have investigated its efficacy for all types of defects. It is indicated in case of superficial defects that are ≤ 3 cm. Closing larger and deeper defects is also possible, but more sutures, a double closure technique, or additional clipping to provide a reinforced layer may be required. It seems to be a beneficial option for the closure of large or irregular resection beds within the right side of the colon and areas with limited space for maneuverability[135,136].
It was reported as a safe, feasible, and effective method of treatment of fistulas (success rates: Technical 95.5%, clinical 54.5%), leaks (57.1%; 28.6%), perforations (100%; 66.7%) and ulcers (100%; 100%), as well as the method of defect closure after ESD (92.7%), EMR (99.2%) polypectomy (100%; 100%), different types of peroral endoscopic myotomy (esophageal - 100%, 100%; gastric 66.7%) and stents fixation[137-141]. X-TackTM HeliX tacking system was reported to be as time-consuming and effective as the OverstitchTM. At the same time, it is much more cost-effective for the closure of lesions up to 35 mm[142]. In the case of insufficient closure using X-TackTM alone, the closure may be achieved by additional implementation of TTSCs[138,139].
In addition, X-TackTM seems to be a safe and reliable novel technique for lumen-apposing metal stent fixation to successfully perform single-session EUS-directed transgastric endoscopic retrograde cholangiopancreatography in patients after Roux-en-Y gastric bypass surgery, with a complete retention reported at the 4-week follow-up[143]. Moreover, it appears to have a high success rate in anastomosis closure after lumen-apposing metal stent removal and should be considered as a primary method for preventing chronic fistulae[144]. Although there is no dedicated removal device, tacks can be removed endoscopically with rotatable endoclip and rotatable rat tooth forceps[145]. X-TackTM is also much more cost-effective because only one device is required. OTS devices are not only more expensive but are also related to additional costs, including clips, grasping, and anchoring tools[146]. X-TackTM is also safe to use with duodenoscopes[147].
FG and PGA sheets are adjunctive techniques to promote wound healing and hemostasis to mitigate the risk of complications such as bleeding and perforation. FG consists of fibrinogen and thrombin. Upon application to the wound surface, fibrinogen is converted into fibrin, forming a stable protein matrix that supports clot formation and healing. PGA sheets act as a mechanical barrier, covering the resection site to minimize vascular exposure and reduce the risk of postoperative bleeding. When PGA is combined with FG (PGA-FG), it adheres firmly to the resected area, effectively protecting and enhancing tissue regeneration.
Studies have confirmed the efficacy of PGA-FG in reducing post-ESD complications. This combination was particularly effective in patients on anticoagulant therapy, showing a marked reduction in hemorrhagic complications[148]. In gastric ESD patients receiving antithrombotic therapy, the shielding method (PGA-FG) demonstrated a lower incidence of delayed bleeding compared to conventional treatment (2.6% vs 14.1%, P = 0.047), further supporting its role in posto
The combination of PGA and FG might be an effective method for minimizing bleeding after ESD, particularly in high-risk patients. By stabilizing the defect, it promotes tissue regeneration and protects the wound from exposure to irritants, enhancing healing. Additionally, this technique reduces the need for alternative hemostatic measures, such as endoscopic clipping. However, the high cost of PGA-FG may limit its accessibility. Furthermore, proper training is required for effective application, and the method is less effective for large or deep resections, where alternative interventions may be necessary. Nevertheless, this method holds potential as an adjunctive therapy, especially for patients at high risk of complications.
Recent advancements in third-space endoscopy emphasize the urgent need for advanced devices and techniques to effectively manage defect closure. This review explored novel approaches for managing post-ESD defects and intraprocedural complications to enhance safety and improve long-term outcomes.
Endoscopic closure should be strongly considered for select resection sites following advanced endoscopic procedures. The optimal choice of closure technique depends on multiple factors, including defect size, anatomical location, tissue tension, procedural complexity, cost considerations, and the operator’s technical proficiency with available devices.
Rigorous future studies are essential to establish the clinical efficacy and cost-effectiveness of novel closure methods. Such evidence will be critical for the formulation of standardized, high-quality guidelines that enhance patient outcomes and procedural safety.
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