A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial

Alessandro Repici, Michael Wallace, Prateek Sharma, Pradeep Bhandari, Gianluca Lollo, Roberta Maselli, Cesare Hassan, Douglas Rex

Research output: Contribution to journalArticle

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Abstract

Background and Aims: SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions. Methods: In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant. Results: Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P <.001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P <.001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P =.1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P =.04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P =.052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P =.1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment. Conclusions: In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.)

Original languageEnglish (US)
Pages (from-to)527-535.e5
JournalGastrointestinal Endoscopy
Volume88
Issue number3
DOIs
StatePublished - Sep 1 2018

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Sodium Chloride
Injections
United States Food and Drug Administration
Paris
Telephone
Colon
Randomized Controlled Trials
Clinical Trials
Safety

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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A novel submucosal injection solution for endoscopic resection of large colorectal lesions : a randomized, double-blind trial. / Repici, Alessandro; Wallace, Michael; Sharma, Prateek; Bhandari, Pradeep; Lollo, Gianluca; Maselli, Roberta; Hassan, Cesare; Rex, Douglas.

In: Gastrointestinal Endoscopy, Vol. 88, No. 3, 01.09.2018, p. 527-535.e5.

Research output: Contribution to journalArticle

Repici, A, Wallace, M, Sharma, P, Bhandari, P, Lollo, G, Maselli, R, Hassan, C & Rex, D 2018, 'A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial', Gastrointestinal Endoscopy, vol. 88, no. 3, pp. 527-535.e5. https://doi.org/10.1016/j.gie.2018.04.2363
Repici, Alessandro ; Wallace, Michael ; Sharma, Prateek ; Bhandari, Pradeep ; Lollo, Gianluca ; Maselli, Roberta ; Hassan, Cesare ; Rex, Douglas. / A novel submucosal injection solution for endoscopic resection of large colorectal lesions : a randomized, double-blind trial. In: Gastrointestinal Endoscopy. 2018 ; Vol. 88, No. 3. pp. 527-535.e5.
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abstract = "Background and Aims: SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions. Methods: In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant. Results: Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56{\%}) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36{\%}; proximal colon, 74{\%}) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P <.001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P <.001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P =.1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P =.04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P =.052) and a higher rate of en bloc resections (19/102, 18.6{\%} vs 12/111, 11.0{\%}; P =.1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6{\%}; saline solution, 17{\%}), and none of the serious adverse events (SIC-8000, 8.8{\%}; saline solution, 10.7{\%}) were related to the study treatment. Conclusions: In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.)",
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TY - JOUR

T1 - A novel submucosal injection solution for endoscopic resection of large colorectal lesions

T2 - a randomized, double-blind trial

AU - Repici, Alessandro

AU - Wallace, Michael

AU - Sharma, Prateek

AU - Bhandari, Pradeep

AU - Lollo, Gianluca

AU - Maselli, Roberta

AU - Hassan, Cesare

AU - Rex, Douglas

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Background and Aims: SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions. Methods: In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant. Results: Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P <.001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P <.001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P =.1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P =.04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P =.052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P =.1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment. Conclusions: In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.)

AB - Background and Aims: SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions. Methods: In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant. Results: Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P <.001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P <.001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P =.1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P =.04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P =.052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P =.1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment. Conclusions: In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.)

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