Succinylated gelatin substantially increases en bloc resection size in colonic EMR: a randomized, blinded trial in a porcine model
Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size, leading to a higher rate of en bloc resection. To evaluate the safety, efficacy, and impact on EMR specimen size of SG as a submucosal (SM) inj...
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| Published in: | Gastrointestinal endoscopy Vol. 71; no. 3; pp. 589 - 595 |
|---|---|
| Main Authors: | , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Maryland heights, MO
Mosby, Inc
01.03.2010
Elsevier |
| Subjects: | |
| ISSN: | 0016-5107, 1097-6779, 1097-6779 |
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| Abstract | Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size, leading to a higher rate of en bloc resection.
To evaluate the safety, efficacy, and impact on EMR specimen size of SG as a submucosal (SM) injectant in comparison with normal saline solution (NS).
Randomized, blinded, controlled trial conducted with Animal Ethics Committee approval.
Academic hospital.
Ten swine.
Sixty EMRs (30 using SG vs 30 using NS as 3 paired experiments per animal) of the largest possible en bloc snare resection of normal colonic mucosa after SM injection of a fixed volume of either SG or NS.
EMR specimen size, duration of SM cushion, duration of procedure, ratio of vertical elevation to lateral spread of injectant, ease of resection, adverse effects, perforation, histopathology of EMR sites in colectomy specimens at necropsy (for inflammatory cell content, depth of ulceration, and vascular or ischemic changes).
The mean subject weight was 53 kg. The mean EMR specimen dimensions and surface area were significantly larger with SG (length 37 vs 31 mm,
P = .031; width 32 vs 26 mm,
P = .022; surface area 9.5 cm
2 vs 6.7 cm
2,
P = .044, respectively). The median SM cushion duration was 60 minutes with SG versus 15 minutes with NS (
P = .005). The median procedure duration with SG was 2.6 minutes vs 2.5 minutes with NS (
P = .515). The ratio of vertical elevation to lateral spread of injectant (mean score on a 3-point scale) was 3 with SG versus 2 with NS (
P = .228). Ease of resection score (mean score on a 10-point scale) was 8 with SG versus 7 with NS (
P = .216). There were no systemic adverse effects, hypersensitivity reactions, or bleeding episodes. There were 2 perforations (treated with clips) with SG and 1 with NS (
P = 1.0). Blinded histopathologist assessment of necropsy colectomy specimens did not identify any significant differences between SG and NS EMR sites.
Animal study.
SG is safe and results in a 42% increased surface area for en bloc EMR. Given its other favorable properties, it represents a significant step toward defining the ideal EMR solution. |
|---|---|
| AbstractList | Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size, leading to a higher rate of en bloc resection.
To evaluate the safety, efficacy, and impact on EMR specimen size of SG as a submucosal (SM) injectant in comparison with normal saline solution (NS).
Randomized, blinded, controlled trial conducted with Animal Ethics Committee approval.
Academic hospital.
Ten swine.
Sixty EMRs (30 using SG vs 30 using NS as 3 paired experiments per animal) of the largest possible en bloc snare resection of normal colonic mucosa after SM injection of a fixed volume of either SG or NS.
EMR specimen size, duration of SM cushion, duration of procedure, ratio of vertical elevation to lateral spread of injectant, ease of resection, adverse effects, perforation, histopathology of EMR sites in colectomy specimens at necropsy (for inflammatory cell content, depth of ulceration, and vascular or ischemic changes).
The mean subject weight was 53 kg. The mean EMR specimen dimensions and surface area were significantly larger with SG (length 37 vs 31 mm,
P = .031; width 32 vs 26 mm,
P = .022; surface area 9.5 cm
2 vs 6.7 cm
2,
P = .044, respectively). The median SM cushion duration was 60 minutes with SG versus 15 minutes with NS (
P = .005). The median procedure duration with SG was 2.6 minutes vs 2.5 minutes with NS (
P = .515). The ratio of vertical elevation to lateral spread of injectant (mean score on a 3-point scale) was 3 with SG versus 2 with NS (
P = .228). Ease of resection score (mean score on a 10-point scale) was 8 with SG versus 7 with NS (
P = .216). There were no systemic adverse effects, hypersensitivity reactions, or bleeding episodes. There were 2 perforations (treated with clips) with SG and 1 with NS (
P = 1.0). Blinded histopathologist assessment of necropsy colectomy specimens did not identify any significant differences between SG and NS EMR sites.
Animal study.
SG is safe and results in a 42% increased surface area for en bloc EMR. Given its other favorable properties, it represents a significant step toward defining the ideal EMR solution. Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size, leading to a higher rate of en bloc resection.BACKGROUNDSuccinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size, leading to a higher rate of en bloc resection.To evaluate the safety, efficacy, and impact on EMR specimen size of SG as a submucosal (s.m.) injectant in comparison with normal saline solution (NS).OBJECTIVETo evaluate the safety, efficacy, and impact on EMR specimen size of SG as a submucosal (s.m.) injectant in comparison with normal saline solution (NS).Randomized, blinded, controlled trial conducted with Animal Ethics Committee approval.DESIGNRandomized, blinded, controlled trial conducted with Animal Ethics Committee approval.Academic hospital.SETTINGAcademic hospital.Ten swine.SUBJECTSTen swine.Sixty EMRs (30 using SG vs 30 using NS as 3 paired experiments per animal) of the largest possible en bloc snare resection of normal colonic mucosa after s.m. injection of a fixed volume of either SG or NS.INTERVENTIONSSixty EMRs (30 using SG vs 30 using NS as 3 paired experiments per animal) of the largest possible en bloc snare resection of normal colonic mucosa after s.m. injection of a fixed volume of either SG or NS.EMR specimen size, duration of s.m. cushion, duration of procedure, ratio of vertical elevation to lateral spread of injectant, ease of resection, adverse effects, perforation, histopathology of EMR sites in colectomy specimens at necropsy (for inflammatory cell content, depth of ulceration, and vascular or ischemic changes).MAIN OUTCOME MEASUREMENTSEMR specimen size, duration of s.m. cushion, duration of procedure, ratio of vertical elevation to lateral spread of injectant, ease of resection, adverse effects, perforation, histopathology of EMR sites in colectomy specimens at necropsy (for inflammatory cell content, depth of ulceration, and vascular or ischemic changes).The mean subject weight was 53 kg. The mean EMR specimen dimensions and surface area were significantly larger with SG (length 37 vs 31 mm, P = .031; width 32 vs 26 mm, P = .022; surface area 9.5 cm(2) vs 6.7 cm(2), P = .044, respectively). The median s.m. cushion duration was 60 minutes with SG versus 15 minutes with NS (P = .005). The median procedure duration with SG was 2.6 minutes vs 2.5 minutes with NS (P = .515). The ratio of vertical elevation to lateral spread of injectant (mean score on a 3-point scale) was 3 with SG versus 2 with NS (P = .228). Ease of resection score (mean score on a 10-point scale) was 8 with SG versus 7 with NS (P = .216). There were no systemic adverse effects, hypersensitivity reactions, or bleeding episodes. There were 2 perforations (treated with clips) with SG and 1 with NS (P = 1.0). Blinded histopathologist assessment of necropsy colectomy specimens did not identify any significant differences between SG and NS EMR sites.RESULTSThe mean subject weight was 53 kg. The mean EMR specimen dimensions and surface area were significantly larger with SG (length 37 vs 31 mm, P = .031; width 32 vs 26 mm, P = .022; surface area 9.5 cm(2) vs 6.7 cm(2), P = .044, respectively). The median s.m. cushion duration was 60 minutes with SG versus 15 minutes with NS (P = .005). The median procedure duration with SG was 2.6 minutes vs 2.5 minutes with NS (P = .515). The ratio of vertical elevation to lateral spread of injectant (mean score on a 3-point scale) was 3 with SG versus 2 with NS (P = .228). Ease of resection score (mean score on a 10-point scale) was 8 with SG versus 7 with NS (P = .216). There were no systemic adverse effects, hypersensitivity reactions, or bleeding episodes. There were 2 perforations (treated with clips) with SG and 1 with NS (P = 1.0). Blinded histopathologist assessment of necropsy colectomy specimens did not identify any significant differences between SG and NS EMR sites.Animal study.LIMITATIONSAnimal study.SG is safe and results in a 42% increased surface area for en bloc EMR. Given its other favorable properties, it represents a significant step toward defining the ideal EMR solution.CONCLUSIONSSG is safe and results in a 42% increased surface area for en bloc EMR. Given its other favorable properties, it represents a significant step toward defining the ideal EMR solution. Background Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size, leading to a higher rate of en bloc resection. Objective To evaluate the safety, efficacy, and impact on EMR specimen size of SG as a submucosal (SM) injectant in comparison with normal saline solution (NS). Design Randomized, blinded, controlled trial conducted with Animal Ethics Committee approval. Setting Academic hospital. Subjects Ten swine. Interventions Sixty EMRs (30 using SG vs 30 using NS as 3 paired experiments per animal) of the largest possible en bloc snare resection of normal colonic mucosa after SM injection of a fixed volume of either SG or NS. Main Outcome Measurements EMR specimen size, duration of SM cushion, duration of procedure, ratio of vertical elevation to lateral spread of injectant, ease of resection, adverse effects, perforation, histopathology of EMR sites in colectomy specimens at necropsy (for inflammatory cell content, depth of ulceration, and vascular or ischemic changes). Results The mean subject weight was 53 kg. The mean EMR specimen dimensions and surface area were significantly larger with SG (length 37 vs 31 mm, P = .031; width 32 vs 26 mm, P = .022; surface area 9.5 cm2 vs 6.7 cm2 , P = .044, respectively). The median SM cushion duration was 60 minutes with SG versus 15 minutes with NS ( P = .005). The median procedure duration with SG was 2.6 minutes vs 2.5 minutes with NS ( P = .515). The ratio of vertical elevation to lateral spread of injectant (mean score on a 3-point scale) was 3 with SG versus 2 with NS ( P = .228). Ease of resection score (mean score on a 10-point scale) was 8 with SG versus 7 with NS ( P = .216). There were no systemic adverse effects, hypersensitivity reactions, or bleeding episodes. There were 2 perforations (treated with clips) with SG and 1 with NS ( P = 1.0). Blinded histopathologist assessment of necropsy colectomy specimens did not identify any significant differences between SG and NS EMR sites. Limitations Animal study. Conclusions SG is safe and results in a 42% increased surface area for en bloc EMR. Given its other favorable properties, it represents a significant step toward defining the ideal EMR solution. Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size, leading to a higher rate of en bloc resection. To evaluate the safety, efficacy, and impact on EMR specimen size of SG as a submucosal (s.m.) injectant in comparison with normal saline solution (NS). Randomized, blinded, controlled trial conducted with Animal Ethics Committee approval. Academic hospital. Ten swine. Sixty EMRs (30 using SG vs 30 using NS as 3 paired experiments per animal) of the largest possible en bloc snare resection of normal colonic mucosa after s.m. injection of a fixed volume of either SG or NS. EMR specimen size, duration of s.m. cushion, duration of procedure, ratio of vertical elevation to lateral spread of injectant, ease of resection, adverse effects, perforation, histopathology of EMR sites in colectomy specimens at necropsy (for inflammatory cell content, depth of ulceration, and vascular or ischemic changes). The mean subject weight was 53 kg. The mean EMR specimen dimensions and surface area were significantly larger with SG (length 37 vs 31 mm, P = .031; width 32 vs 26 mm, P = .022; surface area 9.5 cm(2) vs 6.7 cm(2), P = .044, respectively). The median s.m. cushion duration was 60 minutes with SG versus 15 minutes with NS (P = .005). The median procedure duration with SG was 2.6 minutes vs 2.5 minutes with NS (P = .515). The ratio of vertical elevation to lateral spread of injectant (mean score on a 3-point scale) was 3 with SG versus 2 with NS (P = .228). Ease of resection score (mean score on a 10-point scale) was 8 with SG versus 7 with NS (P = .216). There were no systemic adverse effects, hypersensitivity reactions, or bleeding episodes. There were 2 perforations (treated with clips) with SG and 1 with NS (P = 1.0). Blinded histopathologist assessment of necropsy colectomy specimens did not identify any significant differences between SG and NS EMR sites. Animal study. SG is safe and results in a 42% increased surface area for en bloc EMR. Given its other favorable properties, it represents a significant step toward defining the ideal EMR solution. |
| Author | Moss, Alan Hopper, Andrew D. Tran, Kayla Bourke, Michael J. McKay, Gary Kwan, Vu Godfrey, Craig |
| Author_xml | – sequence: 1 givenname: Alan surname: Moss fullname: Moss, Alan – sequence: 2 givenname: Michael J. surname: Bourke fullname: Bourke, Michael J. email: michael@citywestgastro.com.au – sequence: 3 givenname: Vu surname: Kwan fullname: Kwan, Vu – sequence: 4 givenname: Kayla surname: Tran fullname: Tran, Kayla – sequence: 5 givenname: Craig surname: Godfrey fullname: Godfrey, Craig – sequence: 6 givenname: Gary surname: McKay fullname: McKay, Gary – sequence: 7 givenname: Andrew D. surname: Hopper fullname: Hopper, Andrew D. |
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| Keywords | SM SG LST NS normal saline solution submucosal succinylated gelatin laterally spreading tumor Vertebrata Mammalia Treatment Surgery Size Endoscopic mucosal resection Surgical resection Models Artiodactyla Colon Ungulata Pig |
| Language | English |
| License | CC BY 4.0 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved. |
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| Snippet | Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR specimen size,... Background Succinylated gelatin (SG) is an inexpensive colloid that may combine ease of use with the advantages of a colloid to potentially increase EMR... |
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| SubjectTerms | Animals Biological and medical sciences Colon - surgery Digestive system. Abdomen Endoscopy Endoscopy, Gastrointestinal - methods Gastroenterology and Hepatology Gastroenterology. Liver. Pancreas. Abdomen Gelatin - pharmacology Intestinal Mucosa - surgery Investigative techniques, diagnostic techniques (general aspects) Medical sciences Models, Animal Plasma Substitutes - pharmacology Polygeline - pharmacology Stomach, duodenum, intestine, rectum, anus Succinates - pharmacology Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the digestive system Swine |
| Title | Succinylated gelatin substantially increases en bloc resection size in colonic EMR: a randomized, blinded trial in a porcine model |
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