Present address: Medical Office of Okayama Medical Association, Medical Center.
MULTICENTER QUESTIONNAIRE SURVEY ON THE CURRENT SITUATION OF COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION IN JAPAN
Article first published online: 8 MAY 2010
© 2010 The Authors. Journal compilation © 2010 Japan Gastroenterological Endoscopy Society
Special Issue: Proceedings of the Endoscopy Forum Japan 2009
Volume 22, Issue Supplement s1, pages S2–S8, June 2010
How to Cite
Tanaka, S., Tamegai, Y., Tsuda, S., Saito, Y., Yahagi, N. and Yamano, H.-o. (2010), MULTICENTER QUESTIONNAIRE SURVEY ON THE CURRENT SITUATION OF COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION IN JAPAN. Digestive Endoscopy, 22: S2–S8. doi: 10.1111/j.1443-1661.2010.00952.x
Conflicts of interest: The authors declare no potential conflicts of interest.
- Issue published online: 8 MAY 2010
- Article first published online: 8 MAY 2010
- Received 4 November 2009.
- colorectal ESD;
- colorectal tumor;
- questionnaire survey;
- treatment outcome
In order to understand the current use of endoscopic submucosal dissection (ESD) for the treatment of colorectal tumors in Japan, we administered a questionnaire survey to 1356 institutions all over the country. The subject of the survey was colorectal ESD performed from January 2000 to September 2008. Among the 1356 institutions, 391 (28.8%) responded to the questionnaire, and colorectal ESD was currently being performed in 194 institutions. The 194 institutions were almost equally distributed in Japan, that is, colorectal ESD has been performed all over the country. Among these 194 institutions, the procedure had been performed in 100 or more cases in 22 (11.3%) institutions and in 50–99 cases in 18 institutions (9.3%). The knives used in colorectal ESD were the Hook knife, Flush knife, and Flex knife. The average time required for colorectal ESD was 92.2 min, the rate of complete en bloc resection was 83.8%, the perforation rate was 4.8%, and no case of death from complications was reported.
Endoscopic submucosal dissection (ESD) has been widely used as the standard endoscopic technique for the treatment of early gastric cancer in Japan. In April 2008, the national health insurance scheme started to cover the expenses of ESD as a therapeutic procedure for superficial esophageal cancer, and ESD has gradually been used to treat this condition in Japan. Although ESD has been used to treat colorectal tumors, it is not commonly used because of its technical difficulty and high incidence of complications such as perforation. Recently, various devices, peripheral equipment, and techniques for colorectal ESD have been developed; consequently, colorectal ESD has now become a safer and simpler technique. In light of the above circumstances, the Colorectal ESD Standardization Implementation Working Group recently conducted a questionnaire survey to assess the situation of colorectal ESD in Japan. This paper presents the details of the survey.
Participating institutions and survey period
A questionnaire survey on colorectal ESD performed between January 2000 and September 2008 was administered to 1356 institutions that had purchased devices for colorectal ESD from Olympus Corporation (Tokyo, Japan). Among the 1356 institutions approached, 391 (28.8%) responded to the questionnaire; we found that 194 institutions currently perform colorectal ESD. The 194 institutions showed an almost even geographic distribution in Japan, that is, colorectal ESD had been performed all over the country (Fig. 1).
The main items included in the survey were as follows: (i) prevalence of colorectal ESD; (ii) the number of colorectal ESD performed during the survey period; (iii) the number of colorectal ESD performed in the last 1 year; (iv) whether doctors performing colorectal ESD also perform gastric ESD; (v) restrictions on the operator performing colorectal ESD; (vi) types of knives used throughout a procedure; (vii) types of knives used in an institution; (viii) differences in the ESD technique used in the rectum and the colon; (ix) the time required for the ESD procedure; (x) the rate of complete en bloc resection; (xi) the actual condition of complications, such as hemorrhage and perforation; and (xii) the relationship between the incidence of complications and the number of cases in which colorectal ESD had been performed (hereinafter referred to as colorectal ESD cases). According to Tajiri et al.,1‘intraoperative hemorrhage’ was defined as hemorrhage that required special medical treatment, such as emergency surgery, blood transfusion, and administration of vasoconstrictor drugs, or as hemorrhage that resulted in termination of the ESD procedure. Moreover, ‘postoperative hemorrhage’ was defined as major hemorrhage that required a special hemostatic method, or as hemorrhage that resulted in a decrease in the hemoglobin value by more than 2.0 g/dl after the operation when compared to its preoperative value, or as hemorrhage that resulted in massive hematemesis or melena.
Questionnaire survey results
1. The number of institutions according to the total number of colorectal ESD cases (Fig. 2)
Colorectal ESD has been performed in 194 institutions, and the total number of colorectal ESD cases was 8303. Among the 194 institutions, 22 (11.3%) reported 100 or more cases, 18 (9%) reported 50–99 cases, 32 (16.5%) reported 25–49 cases, and 120 (62.9%) reported fewer than 24 cases; that is, institutions in which fewer than 24 colorectal ESD had been performed were the majority. Moreover, 74% of all ESD were performed in institutions where more than 50 procedures had been performed.
2. The number of institutions according to the inaugural year of colorectal ESD (Fig. 3)
Figure 3 shows the number of institutions according to the year in which colorectal ESD was initiated and the year when a knife for colorectal ESD was introduced into the market by Olympus Corporation. Although the data in 2008 were obtained for a period of 9 months, the number of institutions in which colorectal ESD was initiated reached a plateau in 2007.
3. The ratio of colorectal ESD cases performed in the last year of the survey to the total number of accumulated cases (Fig. 4)
The number of total accumulated colorectal ESD cases was 8303. Among them, 3003 cases (36.2%) were performed in the last year.
4. Whether endoscopists performing colorectal ESD also performed gastric ESD (Fig. 5)
Among the 194 institutions where colorectal ESD was performed, the endoscopists who performed colorectal ESD also performed gastric ESD in 180 institutions (92.9%).
5. Restrictions on the operator performing colorectal ESD (Fig. 6)
Among the 194 institutions where colorectal ESD was performed, appropriate qualifications are required for endoscopists to perform colorectal ESD, and endoscopists with skills above a certain level performed the procedure in 179 institutions (92.3%).
6. Types of knives used in a procedure (Fig. 7)
The entire colorectal ESD procedure was performed using only one type of knife in 39 institutions (21.1%); two types of knives were used in the procedure in 25 institutions (12.9%); one type of knife was used in principle during the procedure in 21 institutions (10.8%) and three types were used if necessary; and three institutions (1.5%) did not belong to any of these categories.
7. Types of knives used in an institution (multiple types were used in one institution, Fig. 8)
The type of knife used for colorectal ESD in various institutions was as follows: the Hook knife was used in 146 institutions (75.3%); the Flush knife was used in 100 institutions (51.5%); the Flex knife was used in 82 institutions (42.3%); the B-knife was used in eight institutions (4.1%); the insulation-tipped (IT) knife was used in eight institutions (4.1%); the IT knife 2 was used in 18 institutions (9.3%); and the triangle-tipped knife was used in two institutions (1.0%).
8. Difference in the suitability of the ESD procedure for the rectum and the colon
Among the 194 institutions, the location of the tumor in the rectum was considered as one of the conditions to apply colorectal ESD in 48 institutions (24.7%). Twenty-five of the 48 institutions (12.8% of all institutions) performed ESD only for the rectum.
9. Time required for ESD (Table 1)
The average operative time required for colorectal ESD for all the institutions was 92.2 min, whereas the average time required in the various institutions was as follows: institutions where 100 or more colorectal ESD had been performed, 82.1 min; where 50–99 colorectal ESD were performed, 90.9 min; where 25–49 colorectal ESD were performed, 86.49 min; and where 1–24 colorectal ESD were performed, 95.3 min.
10. Rate of complete en bloc resection (Table 2)
The rate of complete en bloc resection of colorectal ESD for all the institutions was 83.8%. The rate of complete en bloc resection of the institutions where 100 or more colorectal ESD had been performed was 90.2%; that of institutions where 50–99 colorectal ESD had been performed was 83.5%; that of those where 25–49 colorectal ESD had been performed was 85.3%; and that of those where 1–24 colorectal ESD had been performed was 82.2%.
11. Complications (hemorrhage and perforation) (Table 3)
|Experienced cases in each institution||Number of cases||Intraoperative perforation||Delayed perforation||Intraoperative hemorrhage||Bleeding after operation|
|Last 1 year||586||4.1%||2.4%||1.4%||2.6%|
|Last 1 year||570||3.5%||0.7%||0.5%||1.1%|
|Last 1 year||535||5.2%||1.1%||0.0%||2.2%|
|100 ≤ cases||Overall||4836||3.2%||0.4%||0.1%||1.3%|
|Last 1 year||1310||1.8%||0.2%||0.2%||0.9%|
|Last 1 year||3003||3.2%||0.9%||0.4%||1.5%|
The incidences of intraoperative perforation, delayed perforation, intraoperative hemorrhage, and postoperative hemorrhage in the colorectal ESD procedure for all the institutions, were 4.1%, 0.7%, 0.3%, and 1.6%, respectively.
12. Incidence of complication (hemorrhage and perforation) according to the number of ESD cases performed (Figs 9 and 10)
The incidence of (intraoperative or delayed) perforation according to the number of ESD cases performed in each institution has been plotted in Fig. 9. As shown in this figure, the incidence of perforation was higher in institutions where a smaller number of colorectal ESD had been performed, and the incidence of perforation was lower in institutions where a larger number of colorectal ESD had been performed. The incidence of (intraoperative or postoperative) hemorrhage according to the number of ESD cases in each institution has been plotted in Fig. 10. The incidence of hemorrhage was higher in institutions where a smaller number of colorectal ESD had been performed and was lower in institutions where a larger number of colorectal ESD had been performed.
Colorectal ESD is technically difficult to perform, and the risk of complications such as perforation is high; therefore, this risk was included in the clinical studies of each institution. Recently, various techniques for colorectal ESD have been developed in many institutions. Colorectal ESD has been discussed in academic societies and educational seminars, and live demonstration of endoscopy has been held in many areas in Japan. The indications for colorectal ESD have been established by the Colorectal ESD Standardization Implementation Working Group, and devices, endoscopes, and peripheral equipment for colorectal ESD have been developed, improved, released, and popularized. The above activities have increased the safety of colorectal ESD, established its procedures, and simplified its techniques. Consequently, colorectal ESD has been gradually introduced in many institutions.
The questionnaire survey results indicate that colorectal ESD has been performed in 194 institutions throughout Japan. Over 50 cases of colorectal ESD had been recorded in 40 out of 194 institutions, and fewer than 24 had been performed in 120 institutions, which indicated that many institutions had recently introduced colorectal ESD. Of the total colorectal ESD cases, 36% had been performed during the last 1 year. The increase in the number of institutions performing colorectal ESD peaked in 2006 and this number subsequently stabilized.
The necessity of having experience in performing gastric ESD prior to performing colorectal ESD has been frequently discussed. The questionnaire survey results revealed that 94% of endoscopists performing colorectal ESD had also performed gastric ESD. Moreover, restrictions in 92% of the institutions that required endoscopists with appropriate qualifications to perform colorectal ESD indicated that the difficulty in performing colorectal ESD was high. Therefore, it could be said that only endoscopists with skills above a certain level were permitted to perform colorectal ESD in institutions and successfully dealt with colorectal ESD.
The most frequently used knife in colorectal ESD was the Hook knife, followed by the Flush knife and the Flex knife, in that order. Moreover, only one type of knife was used in 20% of the institutions, and two types of knives were used if necessary in many institutions.
The reason for high technical difficulty in performing colorectal ESD is mainly because the large intestine is a long hollow viscus with many folds and bends, so the movement of the endoscope in the large intestine is difficult. However, the rectum is located near the anus; therefore, using the endoscope in the rectum is relatively easier. The questionnaire survey results revealed that 25% of the institutions set ‘rectal lesion’ as one of the indications for colorectal ESD.
No relationship was observed between the number of colorectal ESD cases and the time required for colorectal ESD or rate of complete en bloc resection. No detailed data on the relationship between the operational difficulty and the number of colorectal ESD cases were obtained in this questionnaire survey. However, it is possible that colorectal ESD had been performed for lesions that were smaller and more easily operable in institutions with a smaller number of colorectal ESD cases, and the procedure may have been performed for lesions that were larger and more difficult to operate on in the institutions with a large number of colorectal ESD cases.
The overall incidence of perforation (one of the main complications of this operation) was 4.8%, and this value is less than the 5.9% recorded in a nation-wide investigation involving 30 institutions conducted by Tsuda et al.2 in 2006. Therefore, the safety of this procedure was confirmed to have increased. The overall incidence of hemorrhage was 1.9%. In colorectal lesions, a strong neovascularization is observed in large elevated lesions, cases complicated by fibrosis, and carcinomatous lesions. Therefore, it is sometimes difficult to achieve intraoperative hemostasis. The details of the colorectal ESD cases are unknown; therefore, the numerical values shown in Table 3 are not absolutely reliable. On examining the relationship between the incidence of perforation or hemorrhage and the number of colorectal ESD cases, it was revealed that the incidences of perforation and hemorrhage were lower in the institutions where the number of colorectal ESD cases performed was larger and higher in the institutions where the number of colorectal ESD cases performed was smaller. Therefore, for acquiring a safe colorectal ESD technique, more than a certain number of colorectal ESD cases should have been performed. The questionnaire survey results also revealed that no death occurred as a result of colorectal ESD in Japan.
As mentioned before, colorectal ESD has been performed all over the country without serious problems. The incidence of complications can be reduced by gaining experience in performing colorectal ESD procedures. Several academies, including the Japan Gastroenterological Endoscopy Society, have submitted an application for the national health insurance to cover the expense of colorectal ESD as a therapeutic procedure. In the near future, the national health insurance system will cover the expense of colorectal ESD, after gastric and esophageal ESD. We should periodically conduct nationwide questionnaire surveys in which we will include the details of each case performed in order to understand the actual situation of colorectal ESD.
(Reference) Indications for colorectal ESD
Colorectal ESD is indicated, ‘among lesions to which endoscopic treatment is indicated, a lesion for which en bloc resection is required. However, when snare endoscopic mucosal resection (EMR) is applied to this lesion, piecemeal resection is inevitable.’ The Colorectal ESD Standardization Implementation Working Group, a subordinate organization of the Gastroenterological Endoscopy Promotion Liaison Conference, has proposed the Indication Criteria for Colorectal ESD (Tables 4 and 5).3
|1) Lesions that were larger than 20 mm in diameter in which en bloc resection using snare EMR is difficult, although it isindicative for endoscopic treatment|
|• Non-granular LST, particularly those of the pseudo-depressed type|
|• Lesions with VI type pit pattern|
|• Carcinoma with submucosal infiltration|
|• Large depressed type lesion|
|• Large lesions with elevated type suspected to be cancer†|
|2) Mucosal lesions with fibrosis caused by prolapse due to biopsy or peristalsis of the lesions|
|3) Sporadic localized tumors in chronic inflammation such as ulcerative colitis|
|4) Local residual early cancer after endoscopic resection|
The use of the snare EMR technique for en bloc resection is specifically difficult in large lesions such as: a laterally spreading non-granular type tumor, especially the pseudo-depressed type; lesions with type VI pit patterns; cancer slightly infiltrating into the submucosal layer; a large depressed tumor; and large elevated lesions, probably malignant ones (nodular mixed type lesions such as the granular type laterally spreading tumor). Other indications for colorectal ESD include lesions such as an intramucosal lesion with submucosal fibrosis, which is induced by a biopsy or peristalsis of the lesion, sporadic localized tumor that occurs in chronic inflammation, including ulcerative colitis; and local residual early carcinoma after endoscopic resection. In the above-mentioned lesions, a lesion accompanied by fibrosis is cited as the indication for colorectal ESD. However, the colorectal wall is thinner than the gastric wall, so the risk of perforation during a detachment process in the case of severe fibrosis is remarkably high. Therefore, the degree of fibrosis, the operability of endoscope, and the skill of the endoscopists should always be considered in the practice of ESD.
- 2Complications related to endoscopic submucosal dissection (ESD) of colon and rectum and risk management procedures. Early Colorectal. Cancer 2006; 10: 539–50 (in Japanese with English abstract)..