Int J Gastrointest Interv 2020; 9(1): 19-23
Published online January 31, 2020 https://doi.org/10.18528/ijgii190020
Copyright © International Journal of Gastrointestinal Intervention.
1Division of Gastroenterology, Department of Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea
2Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea
3Department of Pathology, CHA Bundang Medical Center, CHA University, Seongnam, Korea
4Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
Correspondence to:*Division of Gastroenterology, Department of Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, 31 Suncheonhyang 6-gil, Dongnam-gu, Cheonan 31151, Korea.
E-mail address: firstname.lastname@example.org (I.-K. Chung).
Yunho Jung and Chang-Il Kwon contributed equally to this work as first authors.
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: The submucosal lifting gel (Cook Medical Inc., Winston-Salem, NC, USA) is a novel injectate for submucosal lifting of gastrointestinal lesions. The aim of this study was to evaluate the efficacy of the novel submucosal lifting gel for performing endoscopic mucosal resection after precutting (EMR-P) in large gastric lesions.
Methods: A total of 31 artificial lesions were created on body of stomach by electrocautery marking with endoscopic ruler in five live micro-pigs. Three different groups were randomly assigned by the size of artificial lesion such as 3 cm (group 1, 11 cases), 3.5 cm (group 2, 10 cases), and 4 cm (group 3, 10 cases) in diameter. Then EMR-P was performed after injection the lifting gel sufficient unto submucosal layer. Independent observer recorded circumferential resection time, submucosal injection time, injection amount, total procedure time, en bloc and perforation rate.
Results: The mean circumferential resection time was significantly longer in the group 3 in comparison with group 1 and 2 (6.7 ± 1.7 min vs 4.2 ± 1.4 min, P < 0.001 and 4.7 ± 1.5 min, P = 0.004). The mean total procedure time and amount of injection were significant difference between three groups (9.6 ± 2.2 min vs 12.9 ± 2.6 min vs 17.4 ± 2.2 min, P < 0.01) (5.2 ± 1.1 mL vs 6.9 ± 1.4 mL vs 9.3 ± 3.0 mL, P = 0.02). The en bloc rate of each group was 90.9% (10/11), 60.0% (6/10), and 50.0% (5/10) in the group 1, 2, and 3 respectively. There was a perforation during circumferential cutting in group 2.
Conclusion: In a porcine model, a new submucosal lifting gel seems to improve the en bloc rate for performing EMR-P in large gastric lesions, especially 3 cm in diameter.
Keywords: En bloc, Endoscopic mucosal resection, Endoscopic submucosal dissection
Endoscopic submucosal dissection (ESD) is the effective therapeutic technique for precancerous lesions. This technique has become popular in Korea and Japan due to the advantages such as a potential for a high rate of
Recently, submucosal lifting gel (Cook Medical Inc., Winston-Salem, NC, USA) has been demonstrated for submucosal lift of polyps or other gastrointestinal lesions prior to excision. The gel has been proven to be an effective lifting solution to facilitate tissue resection by maintaining a long-lasting submucosal cushion.6 Also, several studies were demonstrated about the function of auto-dissection of gastric submucosal layer.7,8 We expected this gel could improve the
This study was designed as a prospective, controlled, animal, and pilot study. This animal study was conducted at a specific animal research institution under the granting from the National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (Pyeongtaek, Korea) projected of the Ministry of Health and Welfare, Korea. Approval of this study was obtained from animal care committee (MK-IACUC: 130905-001) before study commencement.
Standardized, artificial lesions of 3 cm, 3.5 cm, and 4 cm in diameter were created at the greater curvature of the stomach body where the endoscope can reach easily and naturally by electro-cautery marking with endoscopic ruler in five live micro-pigs (Sus scrofa; mean age 14 months, mean body weight 30.1 kg) (Fig. 1).
Three different groups were assigned by the size of artificial lesions such as 3 cm in diameter (group 1, 11 lesions), 3.5 cm in diameter (group 2, 10 lesions), and 4 cm in diameter (group 3, 10 lesions).
A total of 31 endoscopic procedures were performed by 2 advanced endoscopists (more than 100 cases of stomach or colon ESD). The endoscopists and type of groups were determined randomly by grouped randomized selection.
A single-channel endoscope (GIF-Q260J; Olympus Medical Systems Corp., Tokyo, Japan) and an electrosurgical unit (VIO 300D; ERBE Elektromedizin, Tübingen, Germany) were used for performing endoscopic procedures. A fitted disposable distal attachment cap (D-201; Olympus Medical Systems Corp.) was attached to the tip of the endoscope to optimize visualization.
A mixed solution (a hypertonic saline solution mixed with diluted epinephrine and traces of indigo carmine) was injected for lifting the mucosal and submucosal layer. Then, circumferential cutting was performed with conventional knife such as dual knife and IT-knife2 (Olympus Medical Systems Corp.).
After circumferential cutting, a novel submucosal lifting gel was injected into submucosal layer by the syringe containing the gel. It is connected to a 19 gauge needle, which is attached to a gauge for monitoring pressure, and is delivered to the tissue by a rotatable handle. About 5 to 14 mL of the submucosal lifting gel was sufficiently injected into submucosal layer until observation of the leak through mucosal or submucosal area by the gel (Fig. 2).
Then, the lesions were resected using a 30 mm oval-shaped disposable electrosurgical snare (Olympus Medical Systems Corp.). After we retrieved the excised lesions, the specimens were inspected to determine the
Data were analyzed by using SPSS software ver. 18.0 (IBM Corp., Armonk, NY, USA). Statistical comparisons were made between the groups by using one-way ANOVA test and statistical significance was defined as
All 31 lesions were successfully resected by EMR-P method with a new submucosal lifting gel by two experienced endoscopists. The long and short axis of the mean (± standard deviation) size of resected specimens was 3.5 (± 0.4) cm ¡¿ 3.2 (± 0.6) cm, 4.1 (± 0.7) ¡¿ 3.7 (± 0.4) cm, and 4.8 (± 0.6) ¡¿ 4.4 (± 0.5) cm in the group 1, 2, and 3 respectively. The mean circumferential resection time was significantly longer in the group 3 in comparison with group 1 and 2 (group 3: 6.7 ± 1.7 min vs group 1: 4.2 ± 1.4 min,
There were significant differences of the mean total procedure time (group 1: 9.6 ± 2.2 min vs group 2: 12.9 ± 2.6 min vs group 3: 17.4 ± 2.2 min,
Table 1 . The Overall Result of the EMR-P Using a New Submucosal Lifting Gel.
|Variable||Group 1 (3 cm)||Group 2 (3.5 cm)||Group 3 (4 cm)||P-value|
|Size of resected specimen (long axis, cm)||3.5 ± 0.4||4.1 ± 0.7||4.8 ± 0.6||< 0.01|
|Circumferential cutting time (min)||4.2 ± 1.4||4.7 ± 1.5||6.7 ± 1.7||0.03|
|Submucosal gel injection time (min)||5.2 ± 1.1||6.9 ± 1.4||9.3 ± 3.0||0.02|
|Snaring and resecting time (min)||1.0 ± 0.9||1.9 ± 1.0||2.7 ± 0.9||0.01|
|Total procedure time (min)||9.6 ± 2.2||12.9 ± 2.6||17.4 ± 2.2||< 0.01|
|Injection amount (mL)||5.2 ± 1.1||6.9 ± 1.4||9.3 ± 3.0||< 0.01|
|10/11 (90.9)||6/10 (60.0)||5/10 (50.0)||0.116|
Values are presented as mean ± standard deviation or number (%)..
EMR-P, endoscopic mucosal resection after precutting..
EMR is one of the most common endoscopic techniques for resecting superficial lesions of esophagus, stomach or colon because of its simplicity and safety. Various technique of EMR such as ligation-EMR, cap-EMR, and strip biopsy EMR have been developed. With these conventional techniques, the mean maximal resection size of one-piece resection is about 10–15 mm range.9–13
Limiting in size of obtaining the specimen using these technique, EMR-P method, in which lesions are resected using a snare after circumferential precutting, has been developed. The
Various submucosal lifting solutions have been developed for preventing perforation and improving
A novel submucosal lifting gel which consists of a proprietary combination of known biocompatible components has been tested for biocompatibility and was shown to be non-toxic and a long-lasting submucosal cushion. In addition, it was recently approved by the U.S. Food and Drug Administration for human use.6,8
We believed high viscosity material could lift the mucosal lesion more than low viscosity by filling of submucosal layer. Therefore, we hypothesized the lifting gel can maximize the lifting and separating of the mucosal lesions from proper muscle layer rather than other injection materials including hyaluronic acid. Also, we focused the tissue dissecting properties. Several researches introduced the auto-dissection function.7,8 They showed that there was no further need to carry out any submucosal dissection using a needle knife and no gastric submucosal fibers were visible in any pig after submucosal injection of the lifting gel.7,8 For these reasons, we expected that these advantages could improve the result of the
According to our results, the
There were several limitations in this study. Other injection materials were not compared in same condition during performing EMR-P and this study was small size of animal study.
In conclusion, the submucosal lifting gel seems to improve the
No potential conflict of interest relevant to this article was reported.
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