Digestive Endoscopy 2014; ••: ••–••
doi: 10.1111/den.12396
Original Article
Usefulness of the thread-traction method in esophageal endoscopic submucosal dissection: Randomized controlled trial Yoshiki Koike, Dai Hirasawa, Naotaka Fujita, Yuki Maeda, Tetsuya Ohira, Yoshihiro Harada, Kenjiro Suzuki, Taku Yamagata and Megumi Tanaka Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan Background and Aim: To assess the usefulness of the threadtraction method (TT method) in esophageal endoscopic submucosal dissection (ESD). Methods: A total of 40 lesions that were scheduled to be treated by esophageal ESD were included in the study. The TT method was used for 20 lesions (group TT) and conventional ESD was used for 20 lesions (group C) after randomization. The hookknife method was used in all cases. In group TT, after circumferential mucosal incision, a clip with thread was attached to the oral edge of the lesion. Results: ESD was carried out in all cases. Effective countertrac-
Conclusion: The TT method in esophageal ESD was safe and contributed to shortening of dissection time. The TT method is expected to become widespread as a safe and useful procedure.
tion was created by the TT method, and it was possible to carry out an efficient dissection operation. Significant shortening of
Key words: clip with thread, countertraction, endoscopic submucosal dissection (ESD), hook knife, squamous cell carcinoma
INTRODUCTION
The TT method in ESD is carried out as follows. After circumferential mucosal incision, a clip with thread is attached to the oral edge, including both the mucosa and submucosa of the specimen. Then, the thread is pulled towards the oral side to secure the lesion. As a result, an effective countertraction is obtained, ensuring and maintaining an improved field of view. Efficient dissection then becomes possible,9–15 contributing to shortening of the treatment time. There have been few reports verifying the usefulness of the TT method in esophageal ESD. Therefore, a randomized controlled trial (RCT) was conducted.
E
NDOSCOPIC SUBMUCOSAL DISSECTION (ESD) is an excellent therapeutic procedure enabling en bloc resection regardless of the site and size of the lesion. However, the ESD procedure is complicated and requires a longer treatment time than conventional endoscopic mucosal resection (EMR).1,2 Esophageal ESD is technically more difficult than gastric ESD,3–8 particularly as the esophageal wall is thinner than the gastric wall and the esophageal lumen is narrow, which could result in complications such as perforation and pneumomediastinum.3–5 During esophageal ESD, the mobility of the lesion increases as submucosal dissection proceeds and it becomes difficult to attain effective countertraction. To overcome this problem, the thread-traction method (TT method) has been attempted.9–11
Corresponding: Yoshiki Koike, Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan. Email: [email protected] Received 15 August 2014; accepted 17 October 2014.
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dissection time was achieved in group TT compared with group C (19.8 min vs 31.8 min, P = 0.044). Mean number of local injections during dissection was significantly less in group TT compared with that in group C (0.6 times vs 2.2 times, P < 0.001). As for the amount of local injection, group TT required significantly less compared with group C (2.6 mL vs 7.5 mL, P < 0.01). No complications were encountered.
METHODS Subjects
A
MONG CONSECUTIVE PATIENTS who were diagnosed with esophageal carcinoma by upper gastrointestinal endoscopy at our hospital from May 2012 to February 2013, all 40 lesions that were scheduled to be treated with esophageal ESD were enrolled. Twenty lesions were assigned to group TT and 20 lesions to group C, as
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
1
Y. Koike et al.
2
shown in Table 1. There were significantly more females in group C. Indications for ESD for esophageal carcinoma were in accordance with the guidelines for the diagnosis and treatment of esophageal cancer.17 Patients who were scheduled to undergo ESD for concurrent multiple lesions were also included in the present study. Excluded were patients with ASA (American Society of Anesthesiologists) classification18 III and IV and those who did not give written consent. The present study was carried out after obtaining approval of the ethics committee of our hospital. Written informed consent for study participation was obtained from all participating patients. In addition, this study was registered with UMIN under registration number UMIN 000010003.
Method of randomization A physician who was not directly involved in the study had generated random numbers on a computer, written each number on a piece of paper, and then sealed each piece of paper in an envelope. In accordance with the ordinary ESD procedure, after circumferential mucosal incision of the lesion, dissection was initiated and when countertraction would aid the procedure, an endoscopy nurse opened the sealed envelope and assigned the patient to the appropriate group (i.e. to the group undergoing ESD with the TT method [group TT] or to the group undergoing conventional ESD
Digestive Endoscopy 2014; ••: ••–••
without the TT method [group C]). Allocation of the endoscopist was decided without consideration of information on the lesion.
ESD procedures Endoscopic submucosal dissection was carried out by using a GIF-Q260J (Olympus Medical Systems, Corp., Tokyo, Japan) with a distal attachment (D201-11304; Olympus Medical Systems, Corp.). Incision and dissection were done with a hook knife (KD-620QR; Olympus Medical Systems, Corp.).8,9,15 Local injection of 0.007% epinephrine with 10% glycerin solution was carried out. A high-frequency apparatus ICC200 (Erbe Elektromedizin Ltd, Tübingen, Germany) was used with the settings of autocut mode 50 W and spray coagulation mode 50 W. Carbon dioxide for insufflation was used in all cases. Esophageal ESD was carried out by two endoscopy specialists with extensive experience in carrying out ESD (endoscopist A >1000 cases; endoscopist B > 200 cases).
Clip with thread Clip with thread was composed of a rotatable clip fixing device (Olympus Medical Systems, Corp.), a short clip (HX610-090S; Olympus Medical Systems, Corp.) and 3-0 silk
Table 1 Clinicopathological findings of patients treated with esophageal ESD
Age (years) Gender (M/F) Tumor max. diameter, mm median (range) Specimen max. diameter, mm median (range) Circumferential spread Less than half/half or more Site† Ut/Mt/Lt Macroscopic type† IIa/IIb/IIc Histopathological diagnosis† Histological depth of invasion of SCC EP LPM MM SM1 SM2 Histological depth of invasion of Barrett’s adenocarcinoma SMM †
Group TT (n = 20)
Group C (n = 20)
P-value
71.0 ± 6.3 18/2 24.0 (11–92) 35.5 (21–100)
69.5 ± 9.5 12/8 27.0 (8–48) 37.0 (22–54)
0.581
doi: 10.1111/den.12396
Original Article
Usefulness of the thread-traction method in esophageal endoscopic submucosal dissection: Randomized controlled trial Yoshiki Koike, Dai Hirasawa, Naotaka Fujita, Yuki Maeda, Tetsuya Ohira, Yoshihiro Harada, Kenjiro Suzuki, Taku Yamagata and Megumi Tanaka Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan Background and Aim: To assess the usefulness of the threadtraction method (TT method) in esophageal endoscopic submucosal dissection (ESD). Methods: A total of 40 lesions that were scheduled to be treated by esophageal ESD were included in the study. The TT method was used for 20 lesions (group TT) and conventional ESD was used for 20 lesions (group C) after randomization. The hookknife method was used in all cases. In group TT, after circumferential mucosal incision, a clip with thread was attached to the oral edge of the lesion. Results: ESD was carried out in all cases. Effective countertrac-
Conclusion: The TT method in esophageal ESD was safe and contributed to shortening of dissection time. The TT method is expected to become widespread as a safe and useful procedure.
tion was created by the TT method, and it was possible to carry out an efficient dissection operation. Significant shortening of
Key words: clip with thread, countertraction, endoscopic submucosal dissection (ESD), hook knife, squamous cell carcinoma
INTRODUCTION
The TT method in ESD is carried out as follows. After circumferential mucosal incision, a clip with thread is attached to the oral edge, including both the mucosa and submucosa of the specimen. Then, the thread is pulled towards the oral side to secure the lesion. As a result, an effective countertraction is obtained, ensuring and maintaining an improved field of view. Efficient dissection then becomes possible,9–15 contributing to shortening of the treatment time. There have been few reports verifying the usefulness of the TT method in esophageal ESD. Therefore, a randomized controlled trial (RCT) was conducted.
E
NDOSCOPIC SUBMUCOSAL DISSECTION (ESD) is an excellent therapeutic procedure enabling en bloc resection regardless of the site and size of the lesion. However, the ESD procedure is complicated and requires a longer treatment time than conventional endoscopic mucosal resection (EMR).1,2 Esophageal ESD is technically more difficult than gastric ESD,3–8 particularly as the esophageal wall is thinner than the gastric wall and the esophageal lumen is narrow, which could result in complications such as perforation and pneumomediastinum.3–5 During esophageal ESD, the mobility of the lesion increases as submucosal dissection proceeds and it becomes difficult to attain effective countertraction. To overcome this problem, the thread-traction method (TT method) has been attempted.9–11
Corresponding: Yoshiki Koike, Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan. Email: [email protected] Received 15 August 2014; accepted 17 October 2014.
bs_bs_banner
dissection time was achieved in group TT compared with group C (19.8 min vs 31.8 min, P = 0.044). Mean number of local injections during dissection was significantly less in group TT compared with that in group C (0.6 times vs 2.2 times, P < 0.001). As for the amount of local injection, group TT required significantly less compared with group C (2.6 mL vs 7.5 mL, P < 0.01). No complications were encountered.
METHODS Subjects
A
MONG CONSECUTIVE PATIENTS who were diagnosed with esophageal carcinoma by upper gastrointestinal endoscopy at our hospital from May 2012 to February 2013, all 40 lesions that were scheduled to be treated with esophageal ESD were enrolled. Twenty lesions were assigned to group TT and 20 lesions to group C, as
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
1
Y. Koike et al.
2
shown in Table 1. There were significantly more females in group C. Indications for ESD for esophageal carcinoma were in accordance with the guidelines for the diagnosis and treatment of esophageal cancer.17 Patients who were scheduled to undergo ESD for concurrent multiple lesions were also included in the present study. Excluded were patients with ASA (American Society of Anesthesiologists) classification18 III and IV and those who did not give written consent. The present study was carried out after obtaining approval of the ethics committee of our hospital. Written informed consent for study participation was obtained from all participating patients. In addition, this study was registered with UMIN under registration number UMIN 000010003.
Method of randomization A physician who was not directly involved in the study had generated random numbers on a computer, written each number on a piece of paper, and then sealed each piece of paper in an envelope. In accordance with the ordinary ESD procedure, after circumferential mucosal incision of the lesion, dissection was initiated and when countertraction would aid the procedure, an endoscopy nurse opened the sealed envelope and assigned the patient to the appropriate group (i.e. to the group undergoing ESD with the TT method [group TT] or to the group undergoing conventional ESD
Digestive Endoscopy 2014; ••: ••–••
without the TT method [group C]). Allocation of the endoscopist was decided without consideration of information on the lesion.
ESD procedures Endoscopic submucosal dissection was carried out by using a GIF-Q260J (Olympus Medical Systems, Corp., Tokyo, Japan) with a distal attachment (D201-11304; Olympus Medical Systems, Corp.). Incision and dissection were done with a hook knife (KD-620QR; Olympus Medical Systems, Corp.).8,9,15 Local injection of 0.007% epinephrine with 10% glycerin solution was carried out. A high-frequency apparatus ICC200 (Erbe Elektromedizin Ltd, Tübingen, Germany) was used with the settings of autocut mode 50 W and spray coagulation mode 50 W. Carbon dioxide for insufflation was used in all cases. Esophageal ESD was carried out by two endoscopy specialists with extensive experience in carrying out ESD (endoscopist A >1000 cases; endoscopist B > 200 cases).
Clip with thread Clip with thread was composed of a rotatable clip fixing device (Olympus Medical Systems, Corp.), a short clip (HX610-090S; Olympus Medical Systems, Corp.) and 3-0 silk
Table 1 Clinicopathological findings of patients treated with esophageal ESD
Age (years) Gender (M/F) Tumor max. diameter, mm median (range) Specimen max. diameter, mm median (range) Circumferential spread Less than half/half or more Site† Ut/Mt/Lt Macroscopic type† IIa/IIb/IIc Histopathological diagnosis† Histological depth of invasion of SCC EP LPM MM SM1 SM2 Histological depth of invasion of Barrett’s adenocarcinoma SMM †
Group TT (n = 20)
Group C (n = 20)
P-value
71.0 ± 6.3 18/2 24.0 (11–92) 35.5 (21–100)
69.5 ± 9.5 12/8 27.0 (8–48) 37.0 (22–54)
0.581
