The number of medical facilities that perform colorectal endoscopic submucosal dissection (ESD) has been growing, and its effectiveness has been increasingly reported in recent years. Indications approved by the Japanese government’s medical insurance system are early colorectal cancers with a maximum tumor size of 2–5 cm. ESD was an effective procedure for treating noninvasive colorectal tumors difficult to resect en bloc by conventional EMR, resulting in a higher en bloc resection rate that is less invasive than surgery. Based on the excellent clinical results of colorectal ESDs, the Japanese health care insurance system has approved colorectal ESD for coverage.
Key points
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Endoscopic submucosal dissection (ESD) is a safe and effective procedure for treating colorectal laterally spreading tumors nongranular type (LST-NGs) larger than 20 mm, laterally spreading tumors granular type (LST-Gs) larger than 30 mm, 0-IIc lesions larger than 20 mm, intramucosal tumors with nonlifting sign, and large sessile lesions, which are all difficult to resect en bloc using conventional EMR, providing a higher en bloc resection rate as well as being less invasive than surgery.
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Establishment of a systematic training program for technically more difficult colorectal ESD in addition to further development and refinement of ESD-related instruments, devices, equipment, and injection solutions will help facilitate increased use of colorectal ESD throughout the world.
Introduction
Surgery had been the only available treatment for large colorectal tumors, even those detected at an early stage. In Japan, endoscopic mucosal resection (EMR) is indicated for the treatment of colorectal adenomas, and intramucosal and submucosal superficial (SM1; invasion <1000 μm from the muscularis mucosae) cancers because of the negligible risk of lymph node (LN) metastasis and excellent clinical outcome results.
The endoscopic submucosal dissection (ESD) procedure is accepted as a standard minimally invasive treatment for early gastric and esophageal cancers in Japan. Yamamoto and colleagues and Fujishiro, Yahagi and colleagues and colleagues first started performing colorectal ESDs in the early 2000s, but such procedures were being conducted by only a limited number of specialists. Because of the widespread acceptance of gastric and esophageal ESDs, the number of medical facilities that perform colorectal ESDs has been growing, and the effectiveness of colorectal ESD has been increasingly reported in recent years.
Until the spring of 2012, colorectal ESDs had been performed in Japan in accordance with advanced medical treatment system No. 78 approved by the Japanese Ministry of Health, Labor, and Welfare in 2009, which distinguishes colorectal ESD from gastric and esophageal ESDs because of its greater technical difficulty. The indications for colorectal ESD under this system were defined as (1) early colorectal cancers larger than 20 mm difficult to treat en bloc by EMR; and (2) adenomas with nonlifting sign or residual tumors larger than 10 mm difficult to treat by EMR.
All candidate lesions for ESD had to be confirmed as being an intramucosal tumor using magnification colonoscopy or endoscopic ultrasonography (EUS) before performing the procedure. More than 150 institutions had started performing colorectal ESDs in accordance with the advanced medical treatment system by using recent improvements in ESD-related instruments and devices, as well as various other technical innovations. In fact, a total of 3006 colorectal ESDs were performed in 143 institutions during a recent 1-year period using this advanced medical treatment system. Based on the reported excellent clinical results of colorectal ESDs in Japan, the Japanese health care insurance system has approved colorectal ESD for coverage and set the cost at 183,700 Japanese yen, which is approximately 3 times higher than the cost for conventional EMR. However, most patients younger than 75 years receive a 70% reduction in the treatment cost under the universal health insurance system in Japan.
Introduction
Surgery had been the only available treatment for large colorectal tumors, even those detected at an early stage. In Japan, endoscopic mucosal resection (EMR) is indicated for the treatment of colorectal adenomas, and intramucosal and submucosal superficial (SM1; invasion <1000 μm from the muscularis mucosae) cancers because of the negligible risk of lymph node (LN) metastasis and excellent clinical outcome results.
The endoscopic submucosal dissection (ESD) procedure is accepted as a standard minimally invasive treatment for early gastric and esophageal cancers in Japan. Yamamoto and colleagues and Fujishiro, Yahagi and colleagues and colleagues first started performing colorectal ESDs in the early 2000s, but such procedures were being conducted by only a limited number of specialists. Because of the widespread acceptance of gastric and esophageal ESDs, the number of medical facilities that perform colorectal ESDs has been growing, and the effectiveness of colorectal ESD has been increasingly reported in recent years.
Until the spring of 2012, colorectal ESDs had been performed in Japan in accordance with advanced medical treatment system No. 78 approved by the Japanese Ministry of Health, Labor, and Welfare in 2009, which distinguishes colorectal ESD from gastric and esophageal ESDs because of its greater technical difficulty. The indications for colorectal ESD under this system were defined as (1) early colorectal cancers larger than 20 mm difficult to treat en bloc by EMR; and (2) adenomas with nonlifting sign or residual tumors larger than 10 mm difficult to treat by EMR.
All candidate lesions for ESD had to be confirmed as being an intramucosal tumor using magnification colonoscopy or endoscopic ultrasonography (EUS) before performing the procedure. More than 150 institutions had started performing colorectal ESDs in accordance with the advanced medical treatment system by using recent improvements in ESD-related instruments and devices, as well as various other technical innovations. In fact, a total of 3006 colorectal ESDs were performed in 143 institutions during a recent 1-year period using this advanced medical treatment system. Based on the reported excellent clinical results of colorectal ESDs in Japan, the Japanese health care insurance system has approved colorectal ESD for coverage and set the cost at 183,700 Japanese yen, which is approximately 3 times higher than the cost for conventional EMR. However, most patients younger than 75 years receive a 70% reduction in the treatment cost under the universal health insurance system in Japan.
Indications for colorectal ESD
The indications for colorectal ESD approved by the Japanese government’s medical insurance system are colorectal adenomas and cancers with a maximum tumor size of 2 to 5 cm, taking into account the procedure’s technical standardization and safety throughout Japan at the present time ( Table 1 ).
| Noninvasive Pattern Should be Diagnosed by Chromo-magnification Colonoscopy | ||||
|---|---|---|---|---|
| Tumor size, mm | <10 | ≥10–<20 | ≥20–<30 | ≥30 |
| 0-IIa, IIc, IIa + IIc (LST-NG) a | EMR | EMR | ESD | ESD |
| 0-Is + IIa (LST-G) b | EMR | EMR | EMR | ESD |
| 0-Is (villous) c | EMR | EMR | EMR | ESD |
| Intramucosal tumor with nonlifting sign d | EMR | EMR/ESD | ESD | ESD |
| Rectal carcinoid tumor e | EMR | ESD/Surgery | Surgery | Surgery |
a 0-IIa, IIc, IIa + IIc (LST-NGs) >20 mm.
d Intramucosal tumors with nonlifting sign that are difficult to resect en bloc by conventional EMR. Residual and recurrent tumors can be treated by ESD depending on the circumstances; however, such lesions usually involve severe fibrosis so they are not good candidates except in the lower rectum where the perforation risk is very low.
e Rectal carcinoid tumors <1 cm in diameter can be treated by endoscopic submucosal resection using a ligation device simply, safely, and effectively, so not an indication for ESD.
Based on our previous clinicopathological analyses of laterally spreading tumors (LSTs), LST nongranular type (LST-NGs) lesions have a higher rate of submucosal (SM) invasion, which can be difficult to predict endoscopically. Approximately 30% of LST-NGs with SM invasion are multifocal and such invasions are primarily SM superficial (SM1), which is especially difficult to predict before endoscopic treatment. LST-granular type (LST-Gs) lesions have a lower rate of SM invasion and most such invasions are found under the largest nodule or depression and are easier to predict endoscopically. LST-Gs larger than 20 mm can be treated by planning endoscopic piecemeal mucosal resection (EPMR) rather than ESD, with the area having the largest nodule resected first before resection of the remaining tumor. LST-Gs larger than 30 mm are possible candidates for ESD, however, because they have a higher SM invasion rate and are more difficult to treat even by EPMR. Consequently, they are treated by either EPMR or ESD depending on the individual endoscopist’s judgment.
The 0-IIc lesions larger than 20 mm, intramucosal tumors with nonlifting sign, and large sessile lesions, all of which are difficult to resect en bloc by conventional EMR, are also potential candidates for colorectal ESD.
Residual and recurrent tumors can be treated by ESD depending on the circumstances; however, such lesions usually involve severe fibrosis so they are not good candidates, except in the lower rectum, where the risk of perforation is very low.
Rectal carcinoid tumors smaller than 1 cm in diameter can be treated by endoscopic submucosal resection using a ligation device safely, effectively, and easily, so are not an indication for ESD.
Estimating depth of invasion
A noninvasive pattern and Sano Type II or IIIA capillary pattern ( Fig. 1 C ) should be confirmed in each lesion (see Fig. 1 A–D), indicating that the lesion is suitable for EMR or ESD with the estimated invasion depth being less than SM1. No biopsies are recommended before ESD because they can cause fibrosis and may interfere with SM lifting.
ESD Procedure at National Cancer Center Hospital
Materials
Endoscope system
The endoscope system included a water jet endoscope (PCF-Q260JI and GIF-Q260J; Olympus Medical Systems Corp, Tokyo, Japan) with a water jet pump system (OFP1; Olympus Medical Systems Corp) (see Fig. 1 ).
ESD knives
ESD knives included a ball-tip bipolar needle knife with water jet function (Jet B-knife) (XEMEX Co, Tokyo, Japan) and a newly developed insulation-tipped electrosurgical knife (IT knife nano) (KD-612Q; Olympus Optical Co, Tokyo, Japan), in which the insulation-tip is smaller and the short-blade is designed as a small disk to reduce the burning effect on the muscle layer.
Distal attachment
Distal attachment was an ST hood short-type (DH-28GR and 29CR; Fujifilm Medical Co, Tokyo, Japan).
Carbon dioxide regulator
The CO 2 regulator was a UCR (Olympus Medical Systems) or Gas Regulator, Crown (Model FR-IIS-P; Yutaka Engineering, Tokyo, Japan).
Bipolar hemostatic forceps
The bipolar hemostatic forceps used were the HemoStat-Y forceps (H-S2518; Pentax Co, Tokyo, Japan).
Submucosal injection solution
Mixtures of 2 solutions were prepared before ESD to create a longer-lasting SM fluid cushion.
Solution 1: Indigo-carmine dye (2 mL of 1%) and epinephrine (1 mL of 0.1%) were mixed with 200 mL Glyceol (Glyceol, Chugai Pharmaceutical Co, Tokyo, Japan) (10% glycerin and 5% fructose) in a container, and the solution was then drawn into a 5-mL disposable syringe.
Solution 2: MucoUp (MucoUp, Seikakagu Co, Tokyo, Japan) was drawn into another 5-mL syringe.
During the actual ESD procedure, a small amount of solution 1 was injected into the SM layer first to confirm the appropriate SM layer elevation and then solution 2 was injected into the properly elevated SM layer. Finally, a small amount of solution 1 was injected again to flush any residual amount of solution 2.
Electrosurgical generators
The electrosurgical generators were the VIO300D ( Table 2 ) (ERBE, Tubingen, Germany) and ESG100 (Olympus Medical Co, Tokyo, Japan).
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