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reveal their training method of ESD for upper gastrointestinal neoplasm. Materials and Methods: We sent the questionnaire on gastric and esophageal ESD to 9 ...
Digestive Endoscopy (2012) 24 (Suppl. 1), 136–142

doi:10.1111/j.1443-1661.2012.01274.x

TOWARDS FURTHER PENETRATION OF ESD TECHNIQUES – WHAT IS THE ROLE OF JAPANESE ESD EXPERTS? den_1274

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HOW TO TEACH AND LEARN ENDOSCOPIC SUBMUCOSAL DISSECTION FOR UPPER GASTROINTESTINAL NEOPLASM IN JAPAN Kenichi Goda,1 Mitsuhiro Fujishiro,2 Kingo Hirasawa,3 Naomi Kakushima,4 Yoshinori Morita,5 Ichiro Oda,6 Manabu Takeuchi,7 Yorimasa Yamamoto8 and Noriya Uedo9 1

Department of Endoscopy, The Jikei University School of Medicine, Tokyo, 2Department of Endoscopy and Endoscopic Surgery, The University of Tokyo, Tokyo, 3Gastroenterological Center, Yokohama City University Medical Center, Yokohama, 4 Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, 5Department of Gastroenterology, Kobe University, Hyogo, 6 Endoscopy Division, National Cancer Center Hospital, 7Department of Gastroenterology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, 8Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, and 9Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan Background: Endoscopic submucosal dissection (ESD) is an innovative and promising procedure. However, ESD experience is mostly limited to Japan and a few countries in Asia. An appropriate training system should be proposed from Japan to promote a permeation of ESD technique. We conducted questionnaire survey to representative Japanese experts to reveal their training method of ESD for upper gastrointestinal neoplasm Materials and Methods: We sent the questionnaire on gastric and esophageal ESD to 9 Japanese experts in ESD. The questionnaire results were discussed in a session of Endoscopic Forum Japan 2011 held in Tokyo. Results: The inception criteria consisted of two main elements, diagnostic ability and primary endoscopy technique of preceptees. Preceptees should observe and attend as many ESD cases as possible. Most of the experts recommend training with isolated or live animal stomach or esophagus. Lesion in the distal stomach is the most suitable for the first real ESD by a preceptee. Being proficient in a gastric ESD is needed before starting esophageal ESD. Preceptor should have significantly high level of diagnostic ability and proficient ESD techniques in the colorectum as well as the stomach and esophagus. Conclusion: The present questionnaire survey seems to reveal basic elements required for ESD training program. We believe that this is also helpful in other countries where ESD would be initiated and penetrated safely and properly.

Key words: endoscopic submucosal dissection, learn, questionnaire, teach, training.

INTRODUCTION Endoscopic mucosal resection (EMR) is worldwide accepted as being useful for diagnosis and standard treatment for a superficial mucosal tumor of the gastrointestinal tract (esophagus, stomach, colon or rectum).1–4 The most prominent limitation of EMR is that lesions larger than 20 mm in diameter cannot be completely resected with a single EMR procedure, and repeated EMR is required. The repeated EMR can provide pathological misdiagnosis and increase risk of local recurrence.5 Endoscopic submucosal dissection (ESD) was originally developed in Japan. ESD is an innovative and promising procedure to overcome the limitations of EMR. ESD provides en bloc resection of lesions larger than 20 mm in diameter.The en bloc resection has advantages of an improvement in histopathological assessment of R0 resection and it results in the lower risk of recurrence.6,7

Correspondence: Kenichi Goda, Department of Endoscopy, The Jikei University School of Medicine, 3-25-8, Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan. Email: [email protected]

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Received 21 December 2011; accepted 30 January 2012. © 2012 The Authors Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society

Whereas EMR has gained acceptance worldwide, ESD experience is mostly limited at present to Japan and a few countries in Asia. In the other Asian countries as well as Western countries, there has been few data and only small series reported.8,9 This seems to be related to the characteristics of the ESD technique, being technically difficult, timeconsuming and requiring a learning curve. Therefore, we suggest that an appropriate training system should be proposed from Japan to promote a permeation of a safe and proper ESD technique to developing countries with small or no experience of ESD therapy. In order to achieve an establishment of an appropriate training system, we believe that the current training method of ESD primarily has to be established in Japan. Hence, we conducted a questionnaire survey to Japanese experts in representative teaching hospitals regarding their training method of gastric and esophageal ESD.

METHODS We sent the questionnaire on gastric and esophageal ESD to nine Japanese experts in ESD. The questionnaire consisted of the following three topics on ESD training in the stomach

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(a) EGD

(b) Colonoscopy

Pretherapeutic diagnosis Insertion within 15 min. Biopsy skills

Routine endoscopy

Pretherapeutic diagnosis

Understanding of ESD indication Others Others 0

3

6

9

0

3

6

9

Fig. 1. (a) Do you have any inception criteria for gastric or esophageal endoscopic submucosal dissection (ESD) in your hospital? (b) What are the required diagnostic abilities for preceptees to perform esophagogastroduodenoscopy (EGD) or colonoscopy?

Q1-2C: Are any qualifications needed for preceptees?

and esophagus: (i) requirements for preceptees; (ii) training program; and (iii) requirements for preceptors. Multiple answers were allowed for each question; therefore, the total number of answers in several questions exceeded nine. The questionnaire results were discussed in a session of Endoscopic Forum Japan (EFJ) 2011 held in Tokyo, where the nine experts attended as panels.

The most common answer was no need for qualification, but at least 4 years’ postgraduate experience is required. Four of nine experts answered that membership or being a board certificate fellow of the Japan Gastroenterological Endoscopy Society (JGES) is necessary (Fig. 3).

RESULTS

Topic 2: Training program of ESD in the stomach and esophagus

We succeeded in collecting all questionnaires that had been completed by the nine panels. The results are summarized below and showed diagrammatically in the following figures.

Q2-1: Have a stated training program in your hospital? Eight of nine experts answered yes.

Topic 1: Requirements for preceptees to start ESD training

Q2-2A: What is needed for preceptees before the first real ESD?

Q1-1: Do you have any inception criteria for gastric or esophageal ESD in your hospital?

The most common answer was that preceptees should observe and attend ESD procedures as an assistant as many times as possible, but for at least 20 and five cases, respectively (Fig. 4).

Seven of nine experts answered yes.

Q1-2A: What are required diagnostic abilities for preceptees on esophagogastroduodenoscopy (EGD) or colonoscopy? Enough knowledge of pre-therapeutic diagnosis to understand ESD indication and enough technique of diagnostic endoscopy such as excellent skills of routine observation, scope insertion and biopsy technique are needed (Fig. 1).

Q1-2B: What are required therapeutic techniques for preceptees on EGD or colonoscopy? The most common answers were hemostasis and polypectomy/EMR, followed by polypectomy/EMR and clip closure technique, respectively, in EGD and colonoscopy (Fig. 2).

Q2-2B: What is the reason for your answer to the prior question? The most frequent answer was that preceptees need to understand a wide variety of ESD procedures and strategies followed by the need to develop trouble-shooting ability (Fig. 5).

Q2-2C: How can preceptees learn fundamental skills and knowledge of ESD? The most common answer was to attend a seminar or conference followed by participation in a hands-on course or a live demonstration (Fig. 6). © 2012 The Authors Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society

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(a) EGD

(b) Colonoscopy

Hemostasis Polypectomy/EMR

Polypectomy/EMR

Clip Closure None or Others

0

3

6

9

0

3

6

9

Fig. 2. What are required therapeutic techniques for preceptees on (a) esophagogastroduodenoscopy (EGD) or (b) colonoscopy?

No required qualification

Membership or Board Certified Fellow of the JGES

0

3

6

9

Fig. 3. Are any qualifications needed for preceptees? JGES, Japan Gastroenterological Endoscopy Society.

Q2-2D: Do you conduct ESD training for preceptees using animal organs? Eight of nine experts incorporate ex vivo training using animal organs. Q2-2E: What is the most suitable lesion for the first real ESD in the stomach? The most frequent answer was an antral lesion of less than 20 mm in diameter with no ulcer (Fig. 7). Q2-2F: How can you improve preceptees’ skills in the stomach? The great majority, eight of nine experts, promote preceptees’s ESD skill from an antral lesion, the distal stomach to the proximal stomach (Fig. 8). Q2-2G: What are the requirements for competent endoscopists in gastric ESD? The most common answer was acquirement of an ESD skill comparable to a preceptor, having experience of more than

50–100 ESD cases. Being a regular staff in the teaching hospital was the second most common answer (Fig. 9). Q2-2H: When do you switch with a preceptee as an ESD operator? The most frequent answer was when the procedure stalls or if it would take more than 1–2 h. The second most frequent answer was uncontrolled bleeding beyond endoscopic hemostasis or improper use of a device (Fig. 10). Q2-2I: What are the requirements for the first real ESD in the esophagus? Eight of nine experts, the vast majority, answered that being proficient in gastric ESD is necessary before starting esophageal ESD (Fig. 11). Q2-2J: What is the most suitable lesion for the first real ESD in the esophagus? Small lesions of 20 mm or less in diameter or occupying 1/2 or less of the circumference located at other than the left side of the middle esophagus were deemed the most suitable (Fig. 12). © 2012 The Authors Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society

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(a) Observing ESD procedure

(b) Attending ESD procedure as an assistant

As many as possible, > 20 cases

As many as possible, > 5 cases

1 month, 10-20 cases

> 1 case

0

3

6

9

0

3

6

9

Fig. 4. What is needed for preceptees before performing their first real endoscopic submucosal dissection (ESD)?

Understanding a wide variety of ESD procedures and strategies

Antral lesion < 20 mm and with no ulcer

To develop troubleshooting ability

Any lesion other than in cardia or on pyloric ring

0

3

6

9

Fig. 5. What is the reason for your answer to the prior question?

0

3

6

9

Fig. 7. What is the most suitable lesion for the first real endoscopic submucosal dissection (ESD) in the stomach?

Seminar or Conference

Hands-on course or Live demonstration

Step up from the distal to the proximal stomach

Video Step up from any lesion other than in the fornix or on the greater curvature of the body

Textbook

0

3

6

9

Fig. 6. How can preceptees learn fundamental skills and knowledge of endoscopic submucosal dissection (ESD)?

0

Fig. 8.

3

6

9

How can you improve preceptees’ skills in the stomach?

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Comparable technique to preceptor, > 50-100 cases

Proficiency in gastric ESD

Reliable ESD with needle-type or hook knife

Being a regular staff

0

3

6

9

Fig. 9. What are requirements for competent endoscopists in gastric endoscopic submucosal dissection (ESD)?

0

3

6

9

Fig. 11. What are the requirements for the first real endoscopic submucosal dissection (ESD) in the esophagus?

Stalled procedure > 1 or 2 hours Small lesion < 20 mm or occupied < 1/2 circumference

Uncontrolled bleeding

Improper use of a device Right-sided lesion in the middle esophagus Perforation

0

3

6

9

0

3

6

9

Fig. 10. When do you switch with a preceptee as an endoscopic submucosal dissection (ESD) operator?

Fig. 12. What is the most suitable lesion for the first real endoscopic submucosal dissection (ESD) in the esophagus?

Topic 3: Requirements for preceptors

training. However, we should establish a fundamental training program because we believe that we should serve in an advisory capacity to other Asian countries hoping for the introduction and penetration of ESD. The questionnaire survey in the present study seems to reveal key components of the basic program of ESD training in the stomach and esophagus. Most of the Japanese experts start ESD training for preceptees in accordance with inception criteria established by each teaching hospital. The inception criteria are quite similar to one another. The criteria similarly consisted of two main elements: (i) diagnostic ability; and (ii) primary endoscopy technique of preceptees. The diagnostic ability is crucial to judge an ESD indication. Competence for endoscopic hemostasis seems to be a surrogate technical indicator to primary endoscopy technique. As shown by an answer to Q2-2H, uncontrolled bleeding during ESD can be a major reason why a preceptor switches with a preceptee to the role of operator. A previous study revealed that better control of bleeding during ESD was the key to improve completion rates and procedure times of the ESD,11 and also stressed the importance of endoscopic hemostasis.

Q3-1: Are there any necessary qualifications for preceptors in your hospital? Two-thirds of the participants answered yes. Q3-2: What are the requirements for a preceptor? The most common answer on ESD technique was to have a proficiency in ESD in the esophagus, stomach and/or colon. The other answers except for ESD technique were to have great diagnostic ability, considerable experience in endoscopy of more than 10 years, to be a regular staff of a teaching hospital and a board certification of JGES (Fig. 13).

DISCUSSION A previous report suggested that ESD training programs should be tailored according to ethnicity, culture and/or domestic policy because the incidence of disease and working environment may be different.10 The suggestion seems to be well-directed. Therefore, Japanese experts do not necessarily have to establish a universally-available program of ESD

© 2012 The Authors Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society

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(a) ESD technique

(b) Others

High level of diagnostic ability

Proficiency in ESD in the esophagus, stomach, and/or colon

Being a regular staff or with > 10 yrs' experiences No answer or others Board Certified Fellow of the JGES

0

Fig. 13.

3

6

9

0

3

6

9

What are the requirements for a preceptor?

Regarding a questionnaire result related to a necessary qualification, Japanese experts do not take much account of a qualification especially for preceptees. It appears to be more important to have good skills than to own a qualification. However, we recommend that preceptees and preceptors should be at least a member of a gastroenterology-related association of each country because ESD cases should be registered to make sure that ESD is introduced safely and properly.12 The vast majority of the experts answered that preceptees should observe and attend as many ESD cases as possible, but for at least 20 and five cases, respectively. These experiences must lead preceptees to understand the general process of a wide variety of ESD procedures, and to improve the ability to plan wide-ranging ESD strategies and to maintain safety for each procedure. It seems to be useful for preceptees to attend a seminar or hands-on course, watch videos and read textbooks for the purpose of fundamental skill and knowledge of ESD. Most of the experts recommend training with isolated or live animal stomach or esophagus. We believe that self-education and training with the animal organs must accelerate the learning curve to obtain enough ESD knowledge and technique before performing real ESD. The present questionnaire results reveal that all Japanese experts think ESD training should be conducted in a step-up approach after prior experience with conventional EMR, starting with lesions presenting in the distal stomach, proximal stomach and, finally, in the esophagus. A recent study verified that non-ulcerative small lesions (ⱕ20 mm in diameter) in the distal stomach indicated the lowest possibility of non-curative resection.13 Therefore, the present questionnaire results could have validity that lesions in the distal stomach are the most suitable for the first real ESD by a preceptee in terms of having a high curability as well as being technically easy. Western experts proposed that real ESD training should be initiated with the lesion in the rectum because of a higher incidence rate of colorectal cancer than that of stomach.12 In contrast, a panel from Taiwan (Dr I-Lin Lee, Taipei Medical

University, Shuang Ho Hospital) recommended to start ESD training with lesions in the esophagus because he insisted that esophageal cancer is a common target tumor of ESD in Taiwan. An ESD training program would be necessary to adapt depending on the highest incidence rate of target tumors in each country. As with a previous report,14 most Japanese experts set the level of expertise at 50–100 cases of gastric ESD in order to become proficient in gastric ESD. They also recommend starting ESD for esophageal lesions after achieving proficiency in ESD for gastric lesions as shown Figure 11. That means esophageal ESD is generally needed to gain more skills compared to gastric ESD. It is necessary to appreciate the opinion of the Taiwanese panel that real ESD training is initiated on lesions in the esophagus in his hospital. However, we recommend that ESD training with an isolated or live animal esophagus should be conducted before real ESD in a human esophagus. As shown in Figure 12, we also recommend starting the real ESD in the esophagus on small lesions of 20 mm or less in diameter or occupying 1/2 or less of the circumference. Right-sided tumor in the middle esophagus is most suitable lesion for an initial case of real ESD because blood and water usually pool at the left esophageal wall and often obstruct ESD procedure. Blood and water should be rinsed away to keep a wide operative field, making the ESD procedure in the middle esophagus safer and easier. The present questionnaire results indicate many requirements for the preceptor: having quite a high level of diagnostic ability, and having proficient ESD techniques in the colorectum as well as the stomach and esophagus. It is also necessary that they are regular staff with a certified qualification. We have to keep it firmly in mind that preceptors should take full responsibility in managing ESD so that it is performed by preceptees safely with proper indication. In conclusion, the present questionnaire survey seems to reveal basic elements required for an ESD training program, at least in Japan. We believe that this is also helpful in other countries where ESD can be initiated and penetrate safely and properly.

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CONFLICT OF INTEREST None declared.

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© 2012 The Authors Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society