Published online Oct 24, 2023.
https://doi.org/10.5230/jgc.2023.23.e37
Indications for Dental Floss Clip Traction During Gastric Endoscopic Submucosal Dissection by Less-Experienced Endoscopists
Abstract
Purpose
Dental floss clip (DFC) traction-assisted endoscopic submucosal dissection (ESD) is widely performed owing to its simplicity. This study aimed to clarify the appropriate indications for the DFC traction method in early gastric cancer when ESD is performed by less-experienced endoscopists.
Methods and Methods
We retrospectively analyzed 1,014 consecutive patients who had undergone gastric ESD performed by less-experienced endoscopists between January 2015 and December 2020. Gastric ESD was performed without DFC in all cases before December 2017 [DFC (−) group, 376 cases], and ESD was performed with DFC in all cases after January 2018 [DFC (+) group, 436 cases]. The procedure time and rates of en bloc resection, complete resection, and adverse events of the groups were compared.
Results
The procedure time did not differ significantly between the 2 groups. However, when comparing lesions >20 mm, the procedure time in the DFC (+) group was significantly shorter than that in the DFC (−) group (95±46 vs. 75±31, P<0.01). The procedure time for lesions located in the greater curvature of the upper or middle stomach and lesions >20 mm located in the lesser curvature side of the stomach in the DFC (+) group was significantly shorter than that in the DFC (−) group.
Conclusions
The indications for DFC during gastric ESD by less-experienced endoscopists include lesions located in the greater curvature of the upper or middle stomach, and lesions >20 mm located in the lesser curvature of the stomach.
INTRODUCTION
Endoscopic submucosal dissection (ESD), the standard treatment for early gastric cancer in Japan and other countries, allows a high en bloc resection rate with fewer recurrences [1, 2, 3, 4, 5, 6]. However, ESD requires technical skills [1, 4, 7]. Especially for less-experienced endoscopists, proper training is necessary to master ESD techniques. Endoscopists must learn procedures for resection and hemostasis, and how to cope with problems that may arise [8]. Gaining experience with small and simple lesions in the lower stomach and gradually progressing to more difficult lesions is essential [9, 10]. Therefore, one must perform 30–40 ESDs to acquire the adequate skills to perform gastric ESD [11, 12]. However, even with the advanced skill levels of expert endoscopists, ESD is difficult to perform in some cases. Various traction methods have been developed to overcome these issues [13, 14, 15, 16, 17]. The dental floss clip (DFC) traction method is widely used among the clip-with-line methods because it is inexpensive and straightforward. Moreover, it reportedly reduces the procedure time without increasing complications [13, 18, 19, 20, 21]. However, these reports included ESD cases treated primarily by expert endoscopists. Expert endoscopists have found the DFC traction method to be very effective for ESD of early gastric cancer located in the greater curvature of the upper or middle region of the stomach [21]. However, the types of lesions for which less-experienced endoscopists find DFC useful have not yet been reported. In this study, we investigated the indications of DFC in ESD performed by less-experienced endoscopists for early gastric cancer.
MATERIALS AND METHODS
Enrolled patients
Of the 1,014 consecutive patients (1,242 lesions) who underwent gastric ESD between January 2015 and December 2020 at the Hiroshima University Hospital, 294 (430 lesions) were excluded due to the following reasons: procedures performed by expert endoscopists, multiple simultaneous lesions, and change of operator to an expert endoscopist during ESD. Before December 2017, gastric ESD was performed without DFC in all cases [DFC (−) group], whereas ESD was performed with DFC in all cases after January 2018 [DFC (+) group]. The DFC (−) (350 patients, 376 lesions) and DFC (+) (376 patients, 436 lesions) groups were compared (Fig. 1). Resected lesions were histologically diagnosed as absolute or expanded indications according to the Japanese Gastric Cancer Treatment Guidelines [22, 23].
Fig. 1
Flowchart showing the data of patients enrolled in this study. The patients were divided into 2 groups: those who underwent DFC (−) group from January 2015 to December 2017, and those who underwent DFC (+) group from January 2018 to December 2020.
ESD = endoscopic submucosal dissection; DFC (−) group = endoscopic submucosal dissection without dental floss clip; DFC (+) group = endoscopic submucosal dissection with dental floss clip.
According to previous reports, less-experienced endoscopists were defined as those who have performed less than 40 gastric ESDs, while expert endoscopists were those who have performed more than 40 gastric ESDs [8, 11, 12, 24]. The location of the lesion was classified by dividing the stomach into 3 equal sections: upper, middle, and lower parts of the stomach. According to the Japanese Classification of Gastric Carcinoma, the stomach surface is further classified into lesser curvature, greater curvature, anterior wall, and posterior wall [25].
Procedures for gastric ESD
ESD was performed by less-experienced endoscopists. Intravenous sedation with midazolam and pentazocine was initiated with constant monitoring of cardiorespiratory function during the procedure. A single-channel endoscope (GIF-H260Z, or GIF-Q260J; Olympus, Tokyo, Japan) was used [26, 27, 28, 29]. In each case, a standard tip hood (Olympus) was attached to the tip of the endoscope. Marking dots were placed using a standard needle knife or argon plasma coagulation, approximately 5 mm outside the margin of the cancer lesion. A 50/50 mixture of 0.4% sodium hyaluronate (Muco Up; Boston Scientific, Tokyo, Japan) and 10% glycerin solution with a small amount of indigo carmine was prepared and injected into the submucosa. After an initial incision was made with a needle knife, a circumferential incision was made on the mucosa and the submucosa was dissected using an IT knife 2 (KD-611L; Olympus). Hemostasis was performed using a Coagrasper (FD-410LR; Olympus).
In the DFC (+) group, after circumferential incision and submucosal trimming, the endoscope was removed and the DFC traction procedure was performed as follows. A hemoclip (HX-610-090; Olympus) was attached to a reusable delivery catheter (HX-110LR; Olympus). The catheter with an attached clip was inserted through the accessory channel of the endoscope. When the catheter was slightly outside the tip of the endoscope, the clip body was exposed to an extent that it could be retracted. Dental floss (reach, waxed type; Johnson & Johnson K.K., Tokyo, Japan) was secured to the base of the clip arm using a surgeon’s knot. After retracting the DFC into the accessory channel, the endoscope was reinserted into the stomach. Subsequently, the DFC was re-exposed and fixed to the lesion’s edge, and peroral traction was applied. The DFC was also attached to the edge of the mucosal flap on the anal side when the endoscope was used in the retroflex position or on the oral side when the endoscope was used in the straight position. During submucosal dissection, 20 mL of saline solution was attached to the end of the dental floss as a weight or the assistant would pull on the dental floss as needed to obtain the appropriate tension (Fig. 2).
Fig. 2
Endoscopic view of ESD with DFC. (A, B) After circumferential incision, the DFC is attached to the oral side of the resected mucosa. (C, D) DFC gives an appropriate tension, ensures a good submucosal view, and allows safe submucosal dissection.
ESD = endoscopic submucosal dissection; DFC = dental floss clip.
Pathological diagnosis
All ESD specimens were stretched, fixed in 10% buffered formalin, and sectioned at 2-mm intervals. The histopathological type, tumor size, submucosal invasion depth, and resection margins were evaluated in each slice according to the Japanese Classification of Gastric Carcinoma [22]. En bloc resection was defined as the removal of the entire tumor as a single piece. Complete resection was defined as an en bloc resection without tumor cells on the lateral and vertical margins.
Evaluation
The procedure time, en bloc and complete resection rates, and adverse events (delayed bleeding and perforation) of the 2 groups were compared. Additionally, a subgroup analysis of the usefulness of DFC was performed based on the size, location, and position of the lesion, along with the ulcerative findings and macroscopic type. Procedure time was defined as the time from the start of the submucosal injection to the completion of tumor resection. Delayed bleeding was defined as clinical bleeding after ESD that required blood transfusion or endoscopic or surgical intervention [30]. Perforation was diagnosed when mesenteric fat or intra-abdominal space was observed during the procedure or when free air was identified on simple chest and abdominal radiographs after ESD.
Statistical analysis
Statistical analyses were performed using JMP version 15.0 software (SAS Institute Inc., Cary, NC, USA). Quantitative data were presented as means ± standard deviation or percentage, and compared using Pearson’s χ2 test or Fisher’s exact test. Continuous variables were analyzed using the Student’s t-test. Statistical significance was set at P<0.05.
Ethical considerations
The use of patient data in this study was approved by the Institutional Review Board of the Hiroshima University (No. E-1237-1). This study was carried out in accordance with the Declaration of Helsinki and its amendments.
RESULTS
The baseline patient characteristics are presented in Table 1. The treatment outcomes of ESD are shown in Table 2. There were no significant differences between the 2 groups regarding procedure time, en bloc resection, complete resection, specimen size, or complications. The mean number of total ESDs performed by endoscopists was 13.6±6.5 in the DFC (+) group, and 10.4±3.2 in the DFC (−) group. Difference of delayed bleeding and perforation according to the location are shown in Supplementary Tables 1 and 2.
Table 1
Baseline characteristics of patients undergoing gastric endoscopic submucosal dissection
Table 2
Treatment outcomes of patients undergoing gastric endoscopic submucosal dissection
The results of the procedure time according to lesion size, location, presence of ulceration, and gross tumor type are shown in Table 3. The mean procedure time in the DFC (+) group was significantly shorter than that in the DFC (−) group for lesions >20 mm (75±31 vs. 95±46, P<0.01) and for lesions located in the greater curvature of the upper or middle stomach (63±20 vs. 91±53, P<0.01). The results of the procedure time for lesions ≤20 mm are shown in Table 4, and those for lesions >20 mm are shown in Table 5. For lesions located in the greater curvature of the upper or middle stomach, the DFC (+) group had a significantly shorter procedure time than that of the DFC (−) group, regardless of the lesion size. The DFC (+) group had a significantly shorter procedure time than that of the DFC (−) group for lesions >20 mm in the lesser curvature of the stomach.
Table 3
Average procedure time of gastric endoscopic submucosal dissection
Table 4
Average procedure time of gastric endoscopic submucosal dissection (≤20 mm)
Table 5
Average procedure time of gastric endoscopic submucosal dissection (>20 mm)
DISCUSSION
Our study revealed that DFC during gastric ESD performed by less-experienced endoscopists is useful for treating lesions of any size in the greater curvature of the upper or middle stomach and for lesions >20 mm in the lesser curvature of the stomach. The most prominent advantage of our study design was that we eliminated bias in treatment selection by clearly separating the periods with DFC from those without DFC.
ESD is technically challenging for less-experienced endoscopists and requires appropriate training. Several studies have been conducted on the learning curve of gastric ESD [8, 9, 10, 11]. Yamamoto et al. [8] reported that before non-experts start ESD, they must first acquire the skills needed to troubleshoot by assisting experienced endoscopists for at least 1 year and acquire expertise in the hemostasis needed for ESD. Furthermore, they recommended that trainees should start with small lesions so that they have the opportunity to learn the entire ESD procedure before gradually moving on to larger lesions. Regarding the location of the lesion, non-experts should start with lesions in the lower stomach, which are less challenging to resect, and gradually move on to lesions in the upper or middle stomach [9, 10]. Choi et al. [11] reported a learning curve for ESD, with the en bloc rate increasing from 45%–85% after gaining experience in 40 cases. Gotoda et al. [12] commented that at least 30 cases are necessary for non-experts to gain early proficiency in ESD. Lesions in the upper, middle, or greater curvature of the stomach; large lesions (>20 mm); and ulceration are factors that prolong the procedure time and increase the technical difficulty, even for endoscopists proficient in ESD techniques [31]. Therefore, traction methods have been developed to overcome these technical challenges. Although various traction methods have been developed [14, 15, 32, 33, 34, 35], DFC is now the most widely used method because it is inexpensive, simple, and can be performed at any hospital [19, 20, 21].
However, DFC is ineffective for certain gastric lesions. Indications for DFC in gastric ESD must be established because it takes several minutes to attach the DFC. Multicenter randomized trials [21] on gastric ESD with DFC mainly involved expert endoscopists and had a selection bias for lesions to be treated with DFC. For lesions located in the greater curvature of the upper or middle stomach, the mean procedure time in the DFC (+) group of expert endoscopists was significantly shorter. In contrast, the treatment outcomes of less-experienced endoscopists are reported as follows: en bloc resection rate, 93%−100%; perforation rate, 0%−2.6%; and delayed bleeding rate, 1.3%−6% [36, 37]. When ESD with DFC is performed by less-experienced endoscopists, the procedure time tended to be shorter, although the difference was not significant [19, 21].
In this study, there was no trend of procedure time reduction using DFC; furthermore, we demonstrated a detailed comparison of the procedure time by location and size of the lesion. For lesions <20 mm, the procedure time for the DFC-ESD group was significantly shorter than that associated with lesions located on the greater curvature side of the upper or middle stomach. For lesions >20 mm, the procedure time for the DFC-ESD group was significantly shorter than that associated with lesions located on the lesser and greater curvature of the upper or middle stomach or the lesser curvature of the lower stomach. Less-experienced endoscopists have difficulty obtaining a good view of the submucosal dissection line when performing ESD for lesions on the greater curvature of the upper or middle stomach. We believe that DFC can overcome this problem; moreover, the procedure time differed significantly.
Regarding complications, although this is mainly the outcome for expert endoscopists, the rates of delayed bleeding and perforation are reported as follows: 3.8%−4.4% and 0.3%−1.9% in the DFC (+) group, respectively, and 4.4%−9.0% and 2.2%−3% in the DFC (−) group, respectively [19, 20, 21]. Our study also did not show significant differences in complications between the 2 groups, indicating that less-experienced endoscopists can safely perform ESD with DFC.
This study had some limitations. First, this was a retrospective single-center study. However, selection bias was eliminated by dividing the study period according to the use of DFC. Second, although the locations of the lesions treated by less-experienced endoscopists varied, they might have been determined preoperatively to allow easier resection. Third, cases in which the endoscopist changed during ESD were excluded, indicating a bias in case selection.
In conclusion, the indications of DFC for less-experienced endoscopists during gastric ESD are lesions in the greater curvature of the upper or middle stomach, and lesions >20 mm located on the lesser curvature of the stomach.
SUPPLEMENTARY MATERIALS
Difference of delayed bleeding according to the locationSupplementary Table 1
Difference of perforation according to the locationSupplementary Table 2
Conflict of Interest:No potential conflict of interest relevant to this article was reported.
Author Contributions:
Conceptualization: T.H., O.S., T.S.
Data curation: T.H., M.J.
Formal analysis: F.M.
Investigation: T.H., A.K.
Methodology: T.A., U.Y.
Project administration: Y.K., K.Y.
Resources: Y.R.
Supervision: O.S.
Validation: T.H., K.T.
Visualization: T.H., K.T.
Writing - original draft: T.H.
Writing - review & editing: O.S., T.S.
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