Detachable over-the-scope clip for colon defects in the trans intestinal natural orifice transluminal endoscopic cholecystolithotomy: A case report

Abstract

BACKGROUND

Secure transluminal closure remains a fundamental barrier to endoscopic surgery. It has been reported that through-the-scope clips were used to secure the incision of the gallbladder during natural orifice transluminal endoscopic cholecystolithotomy and were left in the body post-operation. The over-the-scope clip (OTSC) is favored for its rapid deployment and strong anchoring capabilities. Nevertheless, OTSCs are difficult to remove once implanted. The Senscure Biotechnology in China has developed a detachable over-the-scope clip (D-OTSC) for this purpose. Here, we utilized the D-OTSC to successfully close a full-thickness sigmoid defect exceeding 1 cm in diameter. Subsequently, the clip was completely removed postoperatively, yielding favorable clinical outcomes.

CASE SUMMARY

We present the case of a 51-year-old female patient who underwent natural orifice transluminal endoscopic cholecystolithotomy. The sigmoid incision was closed using a D-OTSC. Postoperative recovery was uneventful, with no abdominal infection or bleeding. The D-OTSC was subsequently removed via enteroscopy in the outpatient department one month later.

CONCLUSION

The utilization of D-OTSC presents a viable option for closing colonic mucosal incisions ranging from 1 cm to 2 cm.

Key Words: Natural orifice transluminal endoscopic surgery; Over-the-scope clip; Iatrogenic perforation; Full-thickness mucosal defect; Detachable over-the-scope clip; Case report

Core Tip: In response to clinical requirements, ongoing efforts are being made to investigate the utilization of anastomotic or metal clips for the closure of various full-thickness defects in the mucosa of the digestive tract. Here, we present the case of a 51-year-old patient who underwent transintestinal natural orifice transluminal endoscopic cholecystolithotomy. The sigmoid incision was sealed using a detachable over-the-scope clip (D-OTSC), which was subsequently extracted during enteroscopy one month postoperatively. We believe that the D-OTSC is a viable option for closing colon defects ranging from 1 cm to 2 cm.

INTRODUCTION

In response to the increasing demand for endoscopic treatment, endoscopists employ various methods and equipment to address full-thickness defects or iatrogenic perforations of the digestive tract mucosa. Previous literature has extensively documented the successful use of the over-the-scope clip (OTSC) in addressing iatrogenic perforations, gastric hemorrhages, and fistulas, demonstrating favorable clinical outcomes[1,2]. However, it is crucial to acknowledge the limitations of OTSC, such as its cost, its permanent implantation and the presence of artifacts in abdominal imaging post-operation. In response to these challenges, the Senscure Biotechnology in Ningbo, China, has developed a detachable OTSC (D-OTSC). This innovative device facilitated the closure of a large full-thickness defect (diameter greater than 1 cm) of mucous membranes. Remarkably, the D-OTSC was successfully removed one month after the initial operation, showcasing its potential in overcoming the drawbacks associated with traditional OTSCs.

CASE PRESENTATION

Chief complaints

A 51-year-old female presented with intermittent abdominal pain for over three months.

History of present illness

The patient complained of intermittent abdominal pain. She declined surgical cholecystectomy, instead requesting gallbladder preservation therapy and was subsequently admitted to our hospital.

History of past illness

The patient had a prior history of appendectomy, but no history of cholecystitis.

Personal and family history

Her personal and family history was unremarkable.

Physical examination

Physical examination at the time of arrival showed a flat abdomen, no tenderness or rebound pain throughout the abdomen, and no percussion pain in the liver area. Murphy's sign was negative.

Laboratory examinations

Routine blood, liver function and C-reactive protein were within normal limits.

Imaging examinations

Abdominal color Doppler ultrasound revealed the presence of multiple gallstones, the largest measuring approximately 8 mm × 12 mm.

FINAL DIAGNOSIS

The patient was ultimately diagnosed with multiple gallstones.

TREATMENT

Prior to the surgery, the patient orally consumed polyethylene glycol electrolytes to cleanse the intestinal tract. During the procedure, the patient was positioned in lithotomy. A colonoscope was inserted into the intestinal cavity to wash away residual feces and mucus. Subsequently, the intestinal cavity was rinsed and disinfected with 0.1% Aner iodine solution (500 mL). A sterile endoscope with a transparent cap at the tip was then utilized for the surgical operation. A longitudinal incision of approximately 15 mm was made on the anterior wall of the sigmoid colon using a hook knife to access the abdominal cavity (Figure 1A).

Figure 1 Endoscope. A: A longitudinal incision of approximately 15 mm was made on the anterior wall of the sigmoid colon using a hook knife to access the abdominal cavity; B: The endoscope was inserted into the gallbladder cavity; C: An exploration of the gallbladder neck canal was conducted to identify any remaining stones; D: The gallbladder was then sealed with seven hemostatic clip; E: A detachable over-the-scope clip (D-OTSC) was applied to tightly close the incision; F: The original incision was closed with the D-OTSC , and surrounded by newly formed tissue; G: The exposed pulling ring of the D-OTSC was grasped with foreign body forceps, revealing that the clip had decomposed into two flaps; H: Removal of the clip resulted in minor bleeding from the wound surface.

The liver was found by examining upwards along the intestinal canal gap, while the gallbladder was situated at the lower margin of the liver. A disposable polyp snare was utilized to secure a portion of the gallbladder mucosa. Subsequently, the gallbladder was incised using a DUAL knife, resulting in the observation of bile overflow. The bile was completely aspirated using an endoscope, and the incision in the gallbladder was gradually enlarged. The endoscope was then inserted into the gallbladder cavity (Figure 1B). Stones were extracted using a net bag and net basket. Concurrently, an exploration of the gallbladder neck canal was conducted to identify any remaining stones (Figure 1C), and a biopsy of the gallbladder wall was performed. The gallbladder was then sealed with seven hemostatic clip (Figure 1D). The abdominal cavity was irrigated with sterile saline to cleanse any yellow-green bile, following which the instruments were withdrawn, the intestinal incision was closed using a D-OTSC (Figure 1E). The procedure proceeded smoothly, and the patient's postoperative recovery was satisfactory.

OUTCOME AND FOLLOW-UP

One month following the initial procedure, the patient returned to the hospital for removal of the D-OTSC via enteroscopy. Intraoperatively, the original incision was observed to be closed, with the D-OTSC still in place, clamping the incision site and surrounded by newly formed tissue (Figure 1F). The exposed pulling ring of the D-OTSC was grasped with foreign body forceps, revealing that the clip had decomposed into two flaps (Figure 1G). Gradual removal of the clip resulted in minor oozing from the wound surface, which resolved spontaneously within 5 minutes, allowing for safe withdrawal of the endoscope (Figure 1H). The patient reported no postoperative discomfort and recovery was uneventful.

DISCUSSION

Advancements in endoscopic technology have led to the rise of natural orifice transluminal endoscopic surgery (NOTES). Cholelithiasis, a common digestive disease, has seen its global incidence increase from 10% to 15% with rising living standards. Since Liu et al[3] first reported transintestinal cholecystolithotomy in 2015. In 2019, Li and Han[4] first described the transgastric NOTES procedure for gallbladder-preserving surgery. endoscopic cholecystolithotomy via natural lumens has gained significant attention, especially in China[5-7]. How to effectively close the full-thickness mucosal defect or iatrogenic perforation of the digestive tract has become one of the key points in endoscopic treatment, otherwise it can cause serious complications such as septic shock. Residual metal clips in the body pose a concern for patients. Our objective was to address the removal stapling clips post-patient wound healing. This case study first introduces a novel approach to endoscopic incision closure by employing D-OTSC in intestinal incisions during NOTES.

In 2020, the guidelines from the American Gastroenterological Association recommend employing Through-the-scope clips (TTSCs), OTSC, or endoscopic sutures for colon defect closure[8]. TTSCs were initially utilized for gastrointestinal hemostasis in 1975 and have since been increasingly applied for managing iatrogenic gastrointestinal perforations[9]. TTSCs are relatively small in size with a limited closing force, making them suitable for clean incisions up to 1 cm.

TTSCs utilized in the gastrointestinal tract are typically expelled naturally through fecal discharge or extracted during endoscopic procedures. As the field of gallbladder-preserving surgery via NOTES continues to evolve, there is a lack of standardized guidelines for the closure of incisions made in the gallbladder and gastrointestinal tract. Existing literature suggests the use of TTSCs for closing gallbladder incisions[3-7], with no current reports of their removal from these sites. Nevertheless, vigilance is necessary for gallstone recurrence and gallbladder-related complications during postoperative monitoring. The presence of these clips in postoperative imaging may produce artifacts that could impede accurate clinical assessment, and the long-term safety of retaining these clips within the body remains uncertain.

OTSCs are preferred over conventional metal clips for incisions exceeding 1 cm due to their 11-14 mm wingspan, which allows for a more robust tissue grip and closure[10-12]. It offers the advantage of one-step closure, saving time compared to the sequential closure with multiple TTSCs. Despite their effectiveness in closing gastrointestinal wounds, as iatrogenic perforations, digestive tract leaks, and fistulas[1,8,13]. However, some studies have also reported OTSC clips to delayed perforations[14], bleeding, and intestinal obstructions post-release[15]. Regrettably, the safety of prolonged OTSC retention in humans remains inadequately elucidated due to limited long-term follow-up data. In addition, they are very expensive, which limits clinical development.

The Ningbo Senscure Biotechnology in China has developed a D-OTSC, which is half the cost of an OTSC, similar in size and release operation to the OTSC. The release device is affixed to the endoscope’s operational segment (Figure 2A), with the wire hook directing the pull wire onto the take-up reel (Figure 2B). The clip application cap is attached to the endoscope’s front end (Figure 2C). Tissue is drawn into the release device using negative pressure suction or double-arm forceps (Figure 2D), and the D-OTSC is deployed by rapidly rotating the suture take-up reel (Figure 2E). For removal, foreign body or biopsy forceps are used to lift the pull ring, disassembling the clip, and allowing gradual extraction (Figure 2F). Zhang et al[16] successfully treated gastric perforations of 10 to 20 mm using a new detachable endoscopic stapling clip in a porcine animal model. Guan et al[17] reported using a D-OTSC to close an ileocecal incision during endoscopic appendectomy and removing it after 2 months.

Figure 2 Detachable over-the-scope clip. A: Release device installed on endoscope operating part; B: The wire hook leads out the wire and winds it onto the winding drum; C: Install the clamp cap onto the tip of the endoscope; D: Negative pressure suction or endoscopic double arm forceps assisted grasping of tissue; E quickly rotates the winding drum to release the fitting clip; F: Remove the binding wire, disassemble and take out the matching clip. (All images are reproduced from the Instructions for Use of the D-OTSC). The authors have obtained the permission for figure using from the Ningbo Senscure Biotechnology (Supplementary material).

We have applied the D-OTSC in more than 10 cases, for hemostasis and closure of duodenal ulcer bleeding, perforation closure during gastric stromal tumor surgery, and NOTES closure through the stomach. In our clinical observations, we found that the D-OTSC and binding line did not loosen or fall off due to food friction, fecal excretion or gastric acid corrosion, and were released into the body. After removal, the patient did not have obvious adverse reactions and discomfort, which was consistent with an animal study conducted by Zhang et al[16]. We also found that approximately 1 month post-operation was the best time to remove the anastomosis clip. If this time period was extended, the new tissue could easily wrap the D-OTSC, which would lead to difficulty in removal[16]. Although the D-OTSC is designed to be removable without concerns about encountering difficulties in its removal when surrounded by new tissue due to its composition of nickel implant-grade alloy, which exhibits excellent biocompatibility.

However, due to the limited number of relevant studies currently available, our understanding of potential complications remains incomplete and requires further exploration. Notably, only one study by Zhang et al[16] has reported the use of D-OTSC for clamping gastric perforations ranging from 10 mm to 20 mm. Therefore, it is imperative to enhance research efforts to elucidate the clamping efficacy of D-OTSC.

CONCLUSION

Based on the existing literature and our clinical experience, we posit that the D-OTSC effectively closes full-thickness colonic mucosal incisions ranging from 1 cm to 2 cm while allowing for removal, thereby preventing tissue hyperplasia and encapsulation associated with foreign body implantation. It also mitigates artifacts that may arise during computed tomography imaging post-operation. Furthermore, the potential utilization of D-OTSC for gallbladder incision closure warrants anticipation. However, further research is necessary to comprehensively ascertain the constraints and potential complications related to D-OTSC closure.