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OBJECTIVE@#To study the safety of alginate based gastric mucosal protective adhesive and its feasibility as a submucosal injection.@*METHODS@#The feasibility of using alginate-based gastric mucosal protective gel as submucosal injection was evaluated by @*RESULTS@#After injection of different concentrations of alginate base mucosal protective adhesive solution, the uplift height was significantly higher than that of normal saline (@*CONCLUSIONS@#Gastric mucosa protector is a promising new medical device product with feasibility and good biocompatibility as submucosal uplift injection agent.
Subject(s)
Animals , Rats , Adhesives , Alginates , Feasibility Studies , Gastric Mucosa , Injections , SwineABSTRACT
Endoscopic retrograde cholangiopancreatography (ERCP) of the intradiverticular papilla with its invisible orifice remains challenging. Several techniques have been introduced to evert the papillary opening to facilitate cannulation. A 79-year-old woman with bile duct stones underwent ERCP, which revealed that the papilla was located inside a large diverticulum and tended to rotate inward with a trial of papillary cannulation. Submucosal papillary injection of 3 cc of normal saline was performed at 3 and 9 o’clock. Eversion and fixation of a papilla in the diverticulum with this technique allowed selective cannulation of the biliary tree. Stones were retrieved after endoscopic papillary balloon dilation without complications. She had an uneventful post-procedural course. Our findings suggest that submucosal saline injection technique is safe and effective for selective cannulation and can be recommended when cannulation is very difficult because of an intradiverticular papilla.
Subject(s)
Aged , Female , Humans , Ampulla of Vater , Bile Ducts , Biliary Tract , Catheterization , Cholangiopancreatography, Endoscopic Retrograde , Diverticulum , GallstonesABSTRACT
Objective To set up a living mice colonoscopy platform to establish an orthotopic model of colorectal cancer in mice under direct vision,and to observe its biological behavior such as metastasis.Methods Eighteen-week-old male C57/BL mice were anesthetized,and the intestinal lumen of the mice was examined by a self-developed living mice colonoscopy and Olympus URF-P5 ureteroscopy,respectively.The imaging effects of the two methods were compared.Human colon cancer HT-29 cells were injected into the colonic mucosa of BALB/c-nu mice under direct vision.The colonoscopy was performed on the 3rd,7th and 15th day after the injection to observe the tumor formation in the intestinal lumen.The mice were sacrificed when the body weight decreased significantly or cachexia appeared,and then the abdominal cavity was examined including the tumor formation and metastasis.Results The self-developed living mice colonoscopy platform can provide clear vision of enteric cavity,and no mice died in the colonoscopy examination.In vivo subcutaneous injection of HT-29 cells in mice was performed with a perforation rate of 15％,a mortality rate of 33.3％,a tumor formation rate of 62.5％,an abdominal metastasis rate of 60％,a liver metastasis rate of 25％,and an abdominal wall transfer rate of 25％.Conclusion The self-developed mice colonoscopy platform can be used for the study of colorectum in living mice.The imaging effect is no less than that of Olympus URF-P5 ureteroscopy.In addition,an orthotopic colorectal cancer model can be established by this platform combing with submucosal injection technology.
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Objective To evaluate the efficacy and safety of submucosal injection using endoscopic water-jet in peroral endoscopic myotomy (POEM) for treatment of patients with achalasia of cardia (AC). Methods A retrospective analysis was performed on the data of 126 AC patients undergoing POEM in PLA General Hospital from March 2013 to February 2016. All the 126 patients were divided into two groups, 73 in the water-jet group and 53 in the needle injection group. The time to creating a submucosal tunnel, entire operation time, and incidence of complications were compared between the two groups. Results The time to creating a submucosal tunnel and the entire operation time of the water-jet group were both significantly less than those of the needle injection group (6. 38±0. 94 min VS 13. 81±1. 13 min, P<0. 05;27. 81±5. 76 min VS 70. 25±22. 67 min, P<0. 05). The hospital stay of patients after operation was less in the water-jet group than that in the needle injection group (4. 38±1. 87 days VS 5. 64±1. 83 days, P<0. 05). The incidence of bleeding [5. 5％ (4/73) VS 17. 0％ (9/53), P<0. 05] and fever [12. 3％ (9/73) VS 26. 4％ (14/53), P<0. 05] were lower in the water-jet group than those in the needle injection group. The incidences of perforation and pectoralgia were not significantly different between the two groups ( both P>0. 05 ) . Conclusion Endoscopic water-jet injection is safe and effective in POEM, which effectively shortens the time to creat a submucosal tunnel and the operation time, and reduces the incidences of complications including bleeding and fever.
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Objective To evaluate effects and safety of mixed solution of sodium hyaluronate, normal saline and indicarmine during endoscopic submucosal dissection(ESD). Methods A total of 233 patients with gastric, esophageal and colonic lesions diagnosed by endoscopy in the digestive endoscopy center of the First Affiliated Hospital of Soochow University between September 2015 and November 2016 were randomly divided into the experimental group(173 patients)and the control group(50 patients). The experimental group was injected with sodium hyaluronate 100 mg+normal saline 60 mL+0.2% indicarmine 4 mL, and the control group with normal saline 70 mL+0.2% indicarmine 4 mL. The solutions were used for multi-point injection in submucosa outside markers of lesions, respectively, and ESD was performed until lesions were effectively lifted up. The location and size of lesions, operation time, dose of injection and the incidence of complications were compared between the two groups. Results The diameter of resected specimen was 1.9± 1.3 cm in the experimental group, slightly less than that in the control group(2.0 ± 1.8 cm,P>0.05). The operation time from lesion mark to the end of ESD in the experimental group was 59.5±26.7 min,significantly less than that in the control group(68.6±29.0 min, P<0.05). The dose of injection in the experimental group(55.5 ± 31.8 mL)was obviously lower than that in the control group (66.7±35.1 mL,P<0.05). The rate of delayed bleeding in the experimental group was 1.16%(2/173),which was significantly lower than that in the control group[12.00%(6/50), P<0.05]. No delayed perforation occurred in the experimental group,while 3 cases(6.00%)occurred in the control group(P<0.05). Conclusion ESD shows better effects and high safety after the submucosal injection of mixed solution of sodium hyaluronate,normal saline and indicarmine.
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Objective At present,there are a wide range of clinical submucosal injection agents. However,no consensus has been reached on what kind of submucosal injections to use. This study aims to evaluate the feasibility,effectiveness and safety of isopentane as a submucosal injection agent and further provide an evidence for clinical application. Methods Fresh in vitro porcine stomach(In vitro time < 6 h)was used to be submucosal injected with isotonic saline(control group)and isopentane(isopentane group)in 37℃ water bath. We evaluated the injection volume and uplift effect of both submucosal injection agents when the uplift height was 1.5 cm;A 2 cm diameter of mucous uplift was made by isotonic saline or isopentane and then dissected by electrical knife. The opera-tion time was evaluated;20 μL of isotonic saline or isopentane was submucosal injected in living rat stomach. The mucosal uplift height was measured. 1 hour after injection,uplift site(2 mm diameter)was completely dissected by sterile scalpel,bleeding volume was measured within 10 minutes,and the pathological examination of the uplift site was carried out. Results The same height of mucous uplift(1.5 cm)can be achieved by less isopentane[(0.14± 0.07)mL]compared with isotonic saline[(13.65± 4.60)mL],the difference is statistically significant(P<0.01). Isopentane had better uplifting persistency in 5,10,15,20,30,45,60 min(P<0.01).The initial mean uplift area in control group was[(18.10±6.22)cm2],and mean uplift area after 60 min was[(24.24±7.19) cm2],the difference is statistically significant(P=0.03). While isopentane group had a relatively stable uplift area,the mean uplift area was comparable between control group and isopentane group at 0 and 60 min[(22.93± 8.16)cm2vs(21.70± 7.86)cm2,P=0.71]. Similarly,average dissection time was shorter in isopentane group[(3.22±0.53)min]compared with control group[(9.60± 1.98)min](P<0.01). The mucosal thickness variation before and after injection was much more significant in isopentane group than that in control group[(1.34±0.30)mm vs(0.28±0.16)mm,P=0.000]. Conclusion Isopentane submucosal injection can main-tain the effective mucosal uplift height,which is in favor of subsequent endoscopic mucosal resection and has no damage to the tissue. Isopentane is expected to be a new submucosal injection agent.
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Objective To evaluate the feasibilities and advantages of different concentrations of sodium alginate (SA) solutions as a submucosal injection solution for endoscopic submucosal dissection (ESD). Methods In vitro study, different concentrations of sodium alginate solutions and normal saline were injected into submucosal of resected porcine esophagus and stomach respectively, then observe and measure the heights of each injection induced mucosal elevations, and their changes over time. In vivo study, the mimic ESD were conducted in healthy pigs to evaluate the mucosal elevation effect and other assistant effects of sodium alginate as a submucosal injection solution. Results The elevation heights of the experiment groups injected with SA solutions were much higher than the control group injected with normal saline. Specially, the elevation created by 1 % SA in porcine esophagus was significantly higher than that of normal saline (P < 0.01) and the elevation created by 3 % SA was significantly higher than that of normal saline in porcine stomach (P < 0.001). In the mimic ESD experiment, mucosal elevation with clear margin occurred immediately after injection with SA solution. And the durable submucosal fluid cushion created by SA protected deeper tissues while facilitating ESD procedure. Conclusion The elevation heights created by SA solutions were greater and more durable than that created by normal saline, which were crucial for ESD. The viscosity property enabled SA to form a stable protective cushion and prevent bleeding by squeezing tissue around the wound, which may decrease perforation and bleeding rate during ESD procedure. Therefore, sodium alginate can be an ideal clinical submucosal injection solution.
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Objective To compare the effectiveness and safety of different concentrations of elastin-like polypeptides (ELP) as novel submucosal injection material for endoscopic submucosal dissection.Methods Forty healthy New Zealand white rabbits were randomly divided into two groups (n=20).The first group by submucosal injection of different drugs were randomly divide into five groups (n=4).Four concentrations of 50 ku ELP (0.05,0.025,0.012 5,0.005 g/ml) were used separately in each group,while glycerin fructose was used for control group.Each solution (2 ml) was injected into the submucosa through the resected margin,the increase of mucosal thickness and surface changes were observed and recorded at 0,5,10,and 30 min.The subgroup by submucosal injection of different drugs were randomly divide into five groups (n=4).The injection pressure of each solution (2 ml) with the 25-gauge needle was calculated by a manometer,which was connected between the needle and syringe.Results The submucosal uplift heights in groups using the 0.05 g/ml ELP and 0.025 g/ml ELP injection were significantly thicker than that of glycerin fructose (P＜0.05),the 0.012 5 g/ml ELP and glycerin fructose injection showed no significant difference (P＞0.05),whereas the uplift height in glycerin fructose group was thicker than that of the 0.005 g/ml ELP (P＜0.05).The injection pressure correlated with the ELP concentration.The injection pressures of 0.05,0.025,0.012 5,0.005 g/ml ELP solutions were (332±36) kPa,(223±24) kPa,(174±22) kPa and (142±19) kPa,respectively,and that of glycerin fructose was (269±17) kPa.The 0.025 g/ml ELP solution was easily injected into the porcine stomach to create submucosal uplift.The injection pressure of the 0.025 g/ml ELP solution showed significantly lower value compared with that of glycerin fructose (P＜0.05).Conclusions ELP might be a promising agent for submucosal injection for endoscopic submucosal dissection (ESD),and 0.025 g/ml ELP might be efficient concentration for maintaining mucosal elevation,injection pressure and safety.
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Objective To investigate the necessity of adding epinephrine to submucosal injection during endoscopic submucosal dissection(ESD).Methods Patients with early cancer and precancerous lesions of digestive system were prospectively enrolled and underwent ESD when the lesion was 2 cm or more in diameter from December 2013 to January 2014.Patients were randomly divided into two groups,the experimental group(n =54)used saline and indigo carmine for submucosal injection,while the control group(n =47) used a mixed solution including saline,indigo carmine and epinephrine for submucosal injection.Several procedure-related indices and delayed complications were compared between groups.Results All the tumors in both groups were removed en bloc,and all resected lesions showed both lateral and deep tumor-free margins.The mean operation time was 39.4 ±22.0 min in the experimental group,and 41.5 ± 18.7 in the control group.There were no statistical differences between two groups in the en bloc resection rate,complete resection rate,and mean operation time (all P ＞ 0.05).There were no intraoperative or delayed perforations in either group.In the experimental group,mild intraoperative bleeding occurred in 39 cases and moderate in 15 cases.In the control group,mild intraoperative bleeding occurred in 34 cases,moderate in 12 cases,and severe in 1 case.Delayed bleeding occurred in 1 case 3 days after ESD in the experimental group,while none happened in the control group.There were no statistical differences between two groups in intraoperative bleeding or delayed bleeding(P ＞ 0.05).Conclusion The therapeutic effect and complication rate are comparable regardless of addition of epinephrine to submucosal injection during ESD.
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BACKGROUND/AIMS: Commercially available sodium hyaluronate solutions are usually too thick to inject through catheters and need dilution with normal saline (NS) before use, which increases the risk of contamination. We evaluated the usefulness of ready-to-use 0.4% sodium hyaluronate, Endo-Ease (EE; UNIMED Pharm. Inc., Seoul, Korea). METHODS: We performed a prospective multicenter randomized study from May 2011 to September 2012. Patients requiring endoscopic resection (ER) for gastric or colorectal neoplasm at two referral hospitals were enrolled. RESULTS: One hundred fifty-four patients (72 with a gastric neoplasm and 82 with a colorectal neoplasm) were included in intention-to-treat analysis. Thirty-seven gastric neoplasms and 43 colorectal neoplasms were enrolled in the EE group. The usefulness rate was significantly higher in the EE group than in the NS group (89.2% vs. 60.0% for gastric neoplasms and 95.3% vs. 67.7% for colorectal neoplasms, p<0.001). In the EE group, the ease of mucosal resection was significantly higher than in the NS group (p<0.001). The injected volume was smaller in the EE group than in the NS group (p<0.05). CONCLUSIONS: The use of EE reduced the need for additional injections and improved the ease of ER. A submucosal injection of EE is useful for the ER of both gastric and colorectal neoplasms.
Subject(s)
Humans , Catheters , Colorectal Neoplasms , Gastrointestinal Neoplasms , Hyaluronic Acid , Prospective Studies , Referral and Consultation , Seoul , Sodium , Stomach NeoplasmsABSTRACT
Objective To investigate the safety of argon plasma coagulation (APC) with submucosal injection for colon polyps.Methods A total of 30 sets of fresh sigmoid colon from healthy pigs were assigned to control group to receive direct APC,and to treatment group to receive APC with submucosal injection,respectively.After same time and energy of APC,each specimen was sampled for pathological evaluation and the damage extent was determined as mucosa,submucosa (superior 1/3,middle1/3,inferior 1/3),and muscularis propria.Ten cases of colon sessile polyps with diameter of about 1-2 cm,elevated within 3mm by endoscopic ultrasonography(EUS).Direct APC or APC with submucosal injection were performed,respectively,and the difference was observed by EUS.Results In 30 cases of control group,the injury depth of 5 cases reached to the muscularis propria and of 25 cases to submucosa layer,among which 4 cases showed damage to superior submucosa 12 middle submucosa and 9 inferior submucosa.In 30 cases of treatment group,there was no damage to muscularis propria.The injury depth of 26 cases reached submucosa layer,among which 22 cases showed damage to superior submucosa,4 middle submucosa.The results showed significant difference between two groups (P ＜0.01).In patients who underwent APC with submucosal injection,EUS showed effective isolation of mucosa and muscularis propria.It confined the injury to the mucosal layer.Without treatment of submucosal injection in advance,it seemed easier to damage the submucosa and muscularis propria.Conclusion Submucosal injection can protect the colon injured by APC,and may reduce the risk of colon perforation by APC for colon polyps.
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ObjectiveTo explore the safety and efficacy of endoscopic dilatation combined with submucosal injection of triamcinolone acetonide in treatment of benign esophageal stricture.MethodsThe patients of benign esophageal stricture proved by biopsy were randomly divided into three groups.Group A were treated by expansion only,group B were injected with triamcinolone acetonide submucosal combined with expansion,and we treated group C by another injection a week later on the basis of treatment in group B.A 12 months' follow-up was conducted,the dysphagia score,the cure rate.time to sustained symptom relief,re-expansion time interval and adverse reactions were recorded.ResultsSome patients experienced chest pain and regurgitation after the procedure and all improved by corresponding managements.No complications including massive bleeding,infection,perforation or local tissue atrophy were observed.The dysphagia scores in 3 groups after the procedure were all improved ( P ＜ 0.05 ),and no significant difference was noticed between 3 groups (P ＞ 0.05 ).At the end of the follow-up,the duration of dysphagia remission and the interval between 2 consecutive dilatation in Group A were 14.4 ± 3.2 weeks and 18.2 ± 3.7 weeks,respectively,which were significant shorter than those in Group B ( 19.3 ±3.9 weeks and 24.6 ±4.2 weeks,respectively) and those in Group C (20.2 ±4.2 weeks and 26.1 ±4.5 weeks,respectively),while there was no difference between Groups B and C.The cure rate in Group C (43.5％,10/23) was significantly higher than that of Group A (29.2％,7/24) or Group B (27.3％,6/22),while there was no difference between Groups A and B.ConclusionEndoscopic dilatation combined with submucosal injection of triamcinolone acetonide is safe and may improve the symptoms of dysphagia and delay the re-stenosis for patients with benign esophageal stricture,meanwhile,multi-frequency treatment may improve the cure rate.
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BACKGROUND/AIMS: Indications for submucosal saline-epinephrine injection (SSEI) for prevention of postpolypectomy bleeding, in the colon, is variable among endoscopists. The aim of this study was to determine the proper indication for SSEI. METHODS: Clinical data of 1,745 polypectomies was evaluated. Postpolypectomy bleeding after snare polypectomy were evaluated in 1,039 polypectomies. Subgroup analysis was performed in 4 subgroups by size (8 mm) and gross morphology (pedunculated or sessile), also. RESULTS: Submucosal saline-epinephrine injection was used in 679 snare polypectomies. The size of polyps was 9.5+/-4.3 mm. Distribution of polyps showed left side shift in the colon. Sessile polyps (79.4%) and benign adenoma (75.3%) were predominant. Twenty seven episodes (2.6%) of bleeding occurred after snare polypectomy. Rectal polyp, malignant polyp and procedure without SSEI increased bleeding after snare polypectomy with odds ratio 4.71, 10.48 and 3.44, respectively. However, SSEI significantly reduced the bleeding only in patients who had >8 mm sized sessile polyps with odds ratio 16.41 regardless of location and histopathology. CONCLUSIONS: SSEI should be performed in colonoscopic snare polypectomy for >8 mm sized sessile polyps, and might be performed in others for prevention of bleeding at the discretion of the clinician.
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AdenomaABSTRACT
BACKGROUND/AIMS: In EMR, submucosal saline injection is used in order to prevent perforation and hemorrhage, but it is not well known on the physiological change of submucosal layer by injected saline. This study was undertaken to assess experimentally the physiological change of submucosal layer after the saline injection on mongrel's surgical specimens. METHODS: Twenty one fresh specimens were obtained from esophagus, stomach and colon for 3 mongrels' experiments. Saline was injected from 1 mL to 20 mL into submucosa of all specimens on which target areas were made by electrocautery markings. By gross morphology of the elevated area and endoscopic sonographic image and by histological features on submucosa of each specimen, mucosal extension was measured after saline injection. RESULTS: The height of blebs and minimal diameters of target areas made increased up to a fixed dose, but did not increased after that. However, the maximal and minimal diameters of elevated areas and the difference between these diameters increased proportional to the volume of injected saline. Moreover, retained salines were interspersed evenly among the connective tissues in submucosa despite of the increasing dose of injected saline. CONCLUSION: Morphological change in submucosa is not changed proportional to the volume of injected saline.