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Urgent Medical Device Product (ORISE Gel Submucosal Liftiong Agent) Removal by sponsor
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The EPSILON study aims to comparatively evaluate the submucosal injection using ORISETM gel and glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Traditionally, ESD requires the injection of some colloidal solution (glycerol, geloplasma, hydroxyethylstrach, etc.) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion. Alternatives to colloid-solution assisted ESD have also been developped: pocket creation method and saline-immersion ESD.
Recently, other colloidal solutions have arrived on the market, such as gel (ORISETM gel) in order to improve the lifting during ESD.Our preliminary experience using ORISETM gel as a lifting solution for ESD was unexpectedly favourable with few per-procedural bleeding, quick time and facility.
As the spread of ESD is closely associated to its easiness, procedure duration (itself associated to number of procedural bleedings and instruments change through the operating channel) and safety, we sought to study comparatively two submucosal solutions when conducting ESD in a specific population presenting gastric or rectal superficial lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Glycerol | Sham Comparator | Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions. |
|
| Group Gel ORISE | Active Comparator | Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic submucosal dissection | Procedure | Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope |
| Measure | Description | Time Frame |
|---|---|---|
| Increase the dissection speed of the ESD procedure | Increase the dissection speed of the ESD procedure (defined as the dissected surface (mm2)/ESD duration (min). The dissected surface is defined as maximal diameter of specimen (mm) x perpendicular minimal diameter of specimen (mm) measured on ex-vivo pinned stretched specimen onto a cork. ESD duration is defined as the time from first submucosal injection to final cut time. | At day 0 during ESD |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure duration | Total procedure duration (from scope insertion to scope retrieval) (min) | At day 0 during ESD |
| Measure | Description | Time Frame |
|---|---|---|
| Number of per-procedural bleeding | Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating) | At day 0 during ESD |
| Total hemostatic time | Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding) |
Inclusion Criteria:
o Patients must have given written informed consent
o Subjects with documented gastric or rectal lesions with indication of endoscopic removal by ESD, namely:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria cannot be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud Lemmers, MD,PhD | Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital, Université Libre de Bruxelles. (ULB) | Brussels | 1070 | Belgium | |||
| Evangelisches Krankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19693750 | Background | Cao Y, Liao C, Tan A, Gao Y, Mo Z, Gao F. Meta-analysis of endoscopic submucosal dissection versus endoscopic mucosal resection for tumors of the gastrointestinal tract. Endoscopy. 2009 Sep;41(9):751-7. doi: 10.1055/s-0029-1215053. Epub 2009 Aug 19. | |
| 18666315 | Result | Fujishiro M. Perspective on the practical indications of endoscopic submucosal dissection of gastrointestinal neoplasms. World J Gastroenterol. 2008 Jul 21;14(27):4289-95. doi: 10.3748/wjg.14.4289. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2021 | Jul 22, 2021 |
A multicentric, randomized, open label prospective study:
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A computer-based block randomization scheme will be created using block randomization and stratifying by center and by organ type (stomach/rectum). Data will be collected through a printed CRFs and then anonymized and entered into a central web based secured platform.
| use of Orise Gel as lifting agent for endoscopic submucosal dissection | Device | Injection of some colloidal solution (ORISE gel) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion. |
|
| use of glycerol as lifting agent for endoscopic submucosal dissection | Device | Injection of some colloidal solution (glycerol) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion. |
|
| At day 0 during ESD |
| Need for haemostatic forceps | Need for haemostatic forceps during ESD | At day 0 during ESD |
| Difficulty of the dissection | Difficulty of the dissection (scale) (very easy / easy / moderately difficult / difficult / very difficult) | At day 0 during ESD |
| Amount of submucosal solution | Amount of submucosal solution (glycerol or gel) used for ESD in ml | At day 0 during ESD |
| Combined use of saline | Combined use of saline through the knife during ESD (number and ml) | At day 0 during ESD |
| Number of needle injection dots | Number of needle injection dots during ESD (initially / during ESD) | At day 0 during ESD |
| Need to adjust electrosurgical settings | Need to adjust electrosurgical settings during ESD | At day 0 during ESD |
| Clear visualisation of the plane of dissection during ESD (scale). | Clear visualisation of the plane of dissection during ESD (scale). The scale will be defined according the endoscopists evaluation of the delineation between the submucosa ad the underlying muscular layer:
fibrosis) | At day 0 during ESD |
| Rate of en-bloc dissection | Rate of en-bloc dissection (defined as endoscopic resection of the targeted area in one bloc) | At day 0 during ESD |
| Rate of complete endoscopic resection | Rate of complete endoscopic resection (defined as endoscopic evaluation of complete removal of the targeted area in the treated organ) | At day 0 during ESD |
| Quality assessment of the pathological specimen | Quality assessment of the pathological specimen (absolute measure of the depth of resected submucosa on the specimen, rate of clear (horizontal and vertical) margins) | At day 0 during ESD |
| Adverse events | Adverse events:
| From ICF signature up to 2-3 weeks follow-up |
| Düsseldorf |
| 40217 |
| Germany |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| 16721217 | Result | Kodashima S, Fujishiro M, Yahagi N, Kakushima N, Omata M. Endoscopic submucosal dissection using flexknife. J Clin Gastroenterol. 2006 May-Jun;40(5):378-84. doi: 10.1097/00004836-200605000-00004. |
| 21424201 | Result | Park YM, Cho E, Kang HY, Kim JM. The effectiveness and safety of endoscopic submucosal dissection compared with endoscopic mucosal resection for early gastric cancer: a systematic review and metaanalysis. Surg Endosc. 2011 Aug;25(8):2666-77. doi: 10.1007/s00464-011-1627-z. Epub 2011 Mar 18. |
| 22884100 | Result | Lian J, Chen S, Zhang Y, Qiu F. A meta-analysis of endoscopic submucosal dissection and EMR for early gastric cancer. Gastrointest Endosc. 2012 Oct;76(4):763-70. doi: 10.1016/j.gie.2012.06.014. Epub 2012 Aug 9. |
| 26317585 | Result | Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T, Repici A, Vieth M, De Ceglie A, Amato A, Berr F, Bhandari P, Bialek A, Conio M, Haringsma J, Langner C, Meisner S, Messmann H, Morino M, Neuhaus H, Piessevaux H, Rugge M, Saunders BP, Robaszkiewicz M, Seewald S, Kashin S, Dumonceau JM, Hassan C, Deprez PH. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Sep;47(9):829-54. doi: 10.1055/s-0034-1392882. Epub 2015 Aug 28. |
| 15243878 | Result | Fujishiro M, Yahagi N, Kashimura K, Mizushima Y, Oka M, Enomoto S, Kakushima N, Kobayashi K, Hashimoto T, Iguchi M, Shimizu Y, Ichinose M, Omata M. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004 Jul;36(7):579-83. doi: 10.1055/s-2004-814517. |
| 30809079 | Result | Castro R, Libanio D, Pita I, Dinis-Ribeiro M. Solutions for submucosal injection: What to choose and how to do it. World J Gastroenterol. 2019 Feb 21;25(7):777-788. doi: 10.3748/wjg.v25.i7.777. |
| 30716306 | Result | Takezawa T, Hayashi Y, Shinozaki S, Sagara Y, Okada M, Kobayashi Y, Sakamoto H, Miura Y, Sunada K, Lefor AK, Yamamoto H. The pocket-creation method facilitates colonic endoscopic submucosal dissection (with video). Gastrointest Endosc. 2019 May;89(5):1045-1053. doi: 10.1016/j.gie.2019.01.022. Epub 2019 Feb 1. |
| 31327340 | Result | Yamamoto H, Hayashi Y, Despott EJ. The pocket-creation method for endoscopic submucosal dissection combined with saline-immersion: another potential option to overcome challenges in colorectal endoscopic submucosal dissection. Gastrointest Endosc. 2019 Aug;90(2):288-289. doi: 10.1016/j.gie.2019.04.244. No abstract available. |
| 15933932 | Result | Endoscopic Classification Review Group. Update on the paris classification of superficial neoplastic lesions in the digestive tract. Endoscopy. 2005 Jun;37(6):570-8. doi: 10.1055/s-2005-861352. |
| 22609383 | Result | Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15. |
| 26927367 | Result | Sano Y, Tanaka S, Kudo SE, Saito S, Matsuda T, Wada Y, Fujii T, Ikematsu H, Uraoka T, Kobayashi N, Nakamura H, Hotta K, Horimatsu T, Sakamoto N, Fu KI, Tsuruta O, Kawano H, Kashida H, Takeuchi Y, Machida H, Kusaka T, Yoshida N, Hirata I, Terai T, Yamano HO, Kaneko K, Nakajima T, Sakamoto T, Yamaguchi Y, Tamai N, Nakano N, Hayashi N, Oka S, Iwatate M, Ishikawa H, Murakami Y, Yoshida S, Saito Y. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc. 2016 Jul;28(5):526-33. doi: 10.1111/den.12644. Epub 2016 Apr 20. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2021 | Jul 22, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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