Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle / 中国医疗器械杂志

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.

Clinical value of regular endoscopic treatment for esophageal and gastric variceal bleeding in patients with liver cirrhosis / 中华消化内镜杂志

Objective:To evaluate the regular endoscopic therapy for esophageal and gastric variceal bleeding (EGVB) in patients with liver cirrhosis.Methods:A total of 305 patients of EGVB with liver cirrhosis who received endoscopic hemostasis in Nanjing Drum Tower Hospital between January 2015 and January 2018 were included in the retrospective cohort study. Patients were divided into the regular endoscopic treatment group ( n=145) and the irregular endoscopic treatment group ( n=160). The primary outcome measure was rebleeding rate, and the secondary outcome measures were follow-up time, rebleeding interval and rebleeding mortality. Results:There were no significant differences between the two groups in terms of gender composition, average age, etiology composition, the cause of disease under or out of control, liver reserve function, or administration of non-selective β-blockers ( P>0.05), and the baseline data were comparable. The rebleeding rate was 11.7% (17/145) in the regular endoscopic treatment group and 41.9% (67/160) in the irregular endoscopic treatment group ( χ2=38.74, P<0.001). The follow-up time, rebleeding intervals and mortalies of rebleeding in the regular endoscopic treatment group and the irregular endoscopic treatment group were 28.14±11.11 months and 21.10±12.37 months ( t=5.21, P<0.001), 12.0 (6.0, 23.0) months and 1.0 (1.0, 6.0) months ( U=164.00, P<0.001), and 1.4% (2/145) and 10.6% (17/160) ( χ2=11.13, P=0.001), respectively. Conclusion:Compared with irregular endoscopic treatment, regular endoscopic treatment of EGVB in patients with liver cirrhosis has more clinical significance, which can significantly reduce the rebleeding rate, prolong the rebleeding interval, and reduce the mortality of rebleeding.

A randomized control trial of balloon compression-assisted endoscopic injection sclerotherapy for esophageal varices / 中华消化内镜杂志

Objective:To investigate the clinical efficacy and safety of balloon compression-assisted endoscopic injection sclerotherapy (bc-EIS) for esophageal varices in patients with cirrhosis.Methods:From December 2020 to April 2021, cirrhotic patients with esophageal varices who planned to receive endoscopic treatment in the Department of Gastroenterology of the First Affiliated Hospital of Anhui Medical University were selected and randomly divided into the trial group (treated with bc-EIS) and the control group [treated with endoscopic variceal ligation (EVL)] through computer randomization. The varices eradication rate, rebleeding rate and postoperative adverse reactions in the two groups were studied.Results:During the study, 93 cases were initially included according to inclusion criteria, among which 9 cases were excluded by exclusion criteria. Finally, 84 cases were included for data analysis, with 42 cases in each group. The esophageal varices eradication rate after the first treatment in the trial group was 88.10% (37/42), which was significantly higher than that in the control group [33.33% (14/42)] ( χ2=26.40, P<0.001). The esophageal varices eradication rate after 1 to 2 times and 1 to 3 times of treatment in the trial group were both significantly higher than those in the control group [97.62% (41/42) VS 40.48% (17/42), χ2=29.47, P<0.001; 100.00% (42/42) VS 45.24% (19/42), P<0.001]. The maximum follow-up period was 6 months, and none of the patients had rebleeding in the trial group, and the rebleeding rate in the control group was 4.76% (2/42) ( P=0.494). The incidence of thoracic and abdominal discomfort, nausea and vomiting, and abdominal distension in the trial group and control group were 26.19% (11/42) and 35.71% (15/42) ( χ2=0.51, P=0.474), 2.38% (1/42) and 7.14% (3/42) ( χ2=0.26, P=0.608), and 4.76% (2/42) and 11.90% (5/42) ( χ2=0.62, P=0.430), respectively. No other adverse events such as infection, dysphagia, perforation, esophageal tracheal fistula, esophageal stenosis, or ectopic embolism occurred in any group. Conclusion:Bc-EIS is effective and safe for the treatment of esophageal varices in patients with cirrhosis, with a one-time varices eradication rate of more than 85%, and can be completely eradicated after 1 to 3 times of treatment.

Effects of diabetes on rebleeding after endoscopic treatment in liver cirrhosis patients with esophageal varices / 中华消化内镜杂志

Objective@#To investigate whether combined diabetes affects rebleeding after endoscopic treatment in cirrhosis patients with esophageal varices.@*Methods@#A total of 207 liver cirrhosis cases with esophageal varices bleeding who underwent initial treatment of endoscopic variced ligation or endoscopic injection sclerotherapy in the First Affiliated Hospital of Anhui Medical University from June 2015 to March 2018 were included in the retrospective study. The cases were divided into bleeding group (n=54) and non-bleeding group (n=153) according to the presence or absence of rebleeding within 6 months after treatment. The influencing factors on postoperative bleeding were analyzed by univariate analysis and logistic regession analysis.@*Results@#Univariate analysis showed that gender composition, age, presence or absence of portal vein thrombosis, smoking history, drinking history (P=0.05), hypertension, platelet count, total bilirubin level, albumin level, alanine aminotransferase level, prothrombin time, degree of esophageal varices, and surgical methods were not significantly different (all P≥0.05) between the bleeding group and the non-bleeding group. There were significant differences in diabetes, hemoglobin level, blood glucose level, ascites composition, and liver function grade composition between the two groups (all P<0.05). Combined diabetes (yes/no), hemoglobin levels, blood glucose levels, ascites (none-mild/medium-severe), liver function Child-Pugh classification (Grade A/B-C), and history of drinking (yes/no) were included in multivariate analysis, and results showed that diabetes was an independent risk factor for rebleeding after endoscopic treatment of esophageal varices (P=0.008, OR=2.973, 95%CI: 1.322-6.689).@*Conclusion@#After endoscopic treatment of liver cirrhosis patients with esophageal varices, rebleeding is more likely to occur in patients complicated with diabetes.

Risk factors analysis of early rebleeding after endoscopic treatment of esophageal varices / 中华消化内镜杂志

Objective To investigate the risk factors of early rebleeding after endoscopic treatment of esophageal varices. Methods A retrospective analysis was performed on the clinical data of 384 cirrhotic patients with esophageal varices. The factors of early rebleeding group[n=36(9.4%)]and non?bleeding group(n=348)were compared by single factor analysis and multivariate analysis of Logistic regression. Results Single factor analysis showed that there were differences between the two groups in cirrhosis with hepatocellular carcinoma, Child?Pugh classification, Child?Pugh score, ascites volume, portal vein thrombosis, portal vein width, portal hypertensive gastropathy, shapes and numbers of varicose veins, numbers of varicose vein ligation, varicose vein red syndrome, albumin, total bilirubin, prothrombin time, prothrombin activity and platelet number. Further multivariate analysis showed that mass ascites(P=0.000, OR=7.614,95%CI: 3.590?16.147), portal vein thrombosis(P=0.003, OR=2.867, 95%CI: 1.429?5.750),portal hypertensive gastropathy(P=0.000, OR=6.212, 95%CI: 3.036?12.711), and Child?Pugh C(P=0.008,OR=3.078,95%CI:1.338?7.083)were independent risk factors of early rebleeding after endoscopic treatment. Conclusion The early rebleeding rate was high after endoscopic treatment of esophageal varices. Patients with massive ascites,portal vein thrombosis,portal hypertensive gastropathy and Child?Pugh C should be highly vigilant for early rebleeding.

Calcified Macroplastique Substance: A Rare Cause of Recurrent Gross Hematuria after Endoscopic Injection

Endoscopic subureteral injection for treatment of vesicoureteral reflux (VUR) is known to be safe and efficient due to its minimal invasive nature. Being non-migratory, non-antigenic, and biocompatible, Macroplastique (Polydimethylsiloxane) is likely to be stable over time. A 5-year-old boy with a past history of subureteral administration of Macroplastique for unilateral Grade V VUR 4 years ago presented with recurrent gross and microscopic hematuria, along with suprapubic pain. On computed tomography (CT) abdomen, calcified material, suspected to be a stone, was visualized in the bladder. On diagnostic cystoscopy, calcification was seen around the orifice site where Macroplastique injection had been performed. We removed the calcific material by Holmium laser. Endoscopic subureteric implantation has several advantages, but nevertheless, vigilance is needed to detect long-term complications, especially in patients with gross or microscopic hematuria.

Clinical analysis of esophageal submucosal hematoma caused by endoscopic injection sclerotherapy: 5-cases-report and literature review / 中国内镜杂志

Objective To study the etiology clinical features, treatment outcomes and prevention of esophageal submucosal hematoma caused by endoscopic injection sclerotherapy (EIS) of esophageal varices. Methods We retrospectively reviewed the clinical data of patients who were diagnosed with esophageal submucosal hematoma caused by EIS and treated in our hospital from Jan 2014 to July 2016. Five patients were analyzed including one patient receiving endoscopic gastrointestinal catheterization combined with medication, and the remaining four received medication therapy only. Results All five patients were discharged with clinical improvement. However the patients treated only with medication therapy recovered more slowly than the ones who treated with combined therapy. No treatment related side-effects were observed among two treatment groups. Conclusion Endoscopic gastrointestinal catheterization combined with medication may be an effective treatment for esophageal submocasal hematoma caused by EIS. However, the actual clinical efficacy and safety remain to be proven by future large sample randomized clinical studies.

Using Sengstaken-Blakemore tube as assist treatment of escophageal and gastric variceal bleeding under emergency endoscopy / 中国内镜杂志

Objective To evaluate the effect of Sengstaken-Blakemore tube in assisting cyanoacrylate injection combined with sclerotherapy and variceal ligation under emergency endoscopy in treating escophageal and gastric variceal bleeding. Methods 60 patients were randomly selected, and were evenly divided into 2 groups single blindly. Endoscopic cyanoacrylate injection, sclerotherapy and variceal ligation were performed in control group, and additional Sengstaken-Blakemore tube were used in experimental group. Results All the 30 patients in study group got effective hemostasis (30 of 30, 100.00 %), whereas only 23 patients in control groups stopped bleeding (23 of 30, 76.67 %) (P < 0.05). escophageal and gastric variceal were cured 19 patients in the experimental group (19 of 30, 63.33 %) , and only 4 were cured in the control group (4 of 28, 14.28 %) (P < 0.05). Meanwhile, occurence of fever, chest pain, hospital days and hospitalization costs of experimental group was significantly lower than that in control group (P < 0.05). Conclusions Treating the escophageal and gastric variceal bleeding, using endoscopic cyanoacrylate injection, sclerotherapy; and variceal ligation under emergency endoscopy combined with Sengstaken-Blakemore tube could significantly increase the therapeutic efficiency as well as reduce complications and therapy cost.

Risk factors of early rebleeding after endoscopic variceal ligation and/or endoscopic injection of fibrin tissue adhesive / 中华消化内镜杂志

Objective To study the independent risk factors of early rebleeding after endoscopic variceal ligation (EVL) and/or endoscopic injection of fibrin tissue adhesive.Methods Data of 370 patients who had cirrhosis and accepted 396 procedures of EVL and/or endoscopic injection of fibrin tissue adhesive were retrospectively studied.Independent risk factors for early rebleeding were determined by Logistic regression analysis.Results Results of all the factors that were significantly different between the re-bleeding and non-rebleeding patients,the portal vein diameter,ascites volume,Child-Pugh score and serum albumin were independent ones of early rebleeding after EVL and/or endoscopic injection of fibrin tissue adhesive ( P ＜ 0.05).Larger volume of ascites,wider portal vein diameter,reduced albumin,Child-Pugh score greater than 10 were indicative factors of rebleeding.Conclusion The early rebleeding rate after EVL and/or endoscopic injection of fibrin tissue adhesive is determined by portal vein diameter,ascites volume,ChildPugh score,and serum albumin.

Efficacy of Hydrodistention Implantation Technique in Treating High-Grade Vesicoureteral Reflux

PURPOSE: In the endoscopic treatment of vesicoureteral reflux, the relatively high rate of success, the simplicity of the procedure, high patient compliance, and a lack of complications has led to the increased development of injection materials and techniques. We report a method of identifying and maintaining a clear visual field during ureteral and bladder submucosal wall injection of a dextranomer/hyaluronic acid copolymer (Deflux, Oceana, Therapeutics Inc.) by use of the hydrodistention implantation technique (HIT) with the aid of temporary ureteral catheter insertion. MATERIALS AND METHODS: We prospectively reviewed patients with grade IV or V reflux who received an endoscopic injection of Deflux. Reflux grade was evaluated before and after treatment (3 months) by use of voiding cystourethrograms. Conventional sub-trigonal injection (STING) was performed with injection of Deflux underneath the bladder mucosa at the 6 o'clock position. HIT was performed either with hydrodistention or with guidewire insertion. These techniques increase visualization of the intramural portion of the distal ureteral wall. Patients with treatment failures were offered reinjection up to three times. RESULTS: Sixty-three patients completed endoscopic injection and follow-up of 3 months. The overall resolution rate for conventional STING was 58%, i.e., 67% for grade IV and 43% for grade V. The overall resolution rate for HIT was 80%, i.e., 93% for grade IV and 66% for grade V. The modified methods showed higher resolution rates for overall cure owing to the success in patients with grade IV reflux (p=0.026). Although the success of grade V treatment was higher with the modified method, the success rate was not statistically significant (p=0.27). CONCLUSIONS: HIT with the use of either hydrodistention or a guidewire to aid in visualization of the intramural portion of the distal ureter is an effective treatment for high-grade vesico-ureteral reflux.

Ruptured duodenal varices arising from the main portal vein successfully treated with endoscopic injection sclerotherapy: a case report / 대한간학회지

Duodenal varices result from retroperitoneal portosystemic shunts that usually come from the pancreaticoduodenal vein and drain into the inferior vena cava. Because they are a rare but fatal cause of gastrointestinal bleeding, a prompt hemostatic intervention is mandatory. A 62-year-old man who had a history of excessive alcohol consumption presented with massive hematemesis and melena. Emergent endoscopy revealed ruptured varices with an adhering whitish fibrin clot on the postbulbar portion of the duodenum. Abdominal computed tomography demonstrated a cirrhotic liver with venous collaterals around the duodenum and extravasated contrast in the second and third portions. The collaterals originated from the main portal vein and drained via the right renal vein into the inferior vena cava. Endoscopic injection sclerotherapy with cyanoacrylate was successful in achieving hemostasis, and resulted in the near eradication of duodenal varices at a 6-month follow-up.

Portal and Mesenteric Venous Thrombosis Complicating Endoscopic Injection Sclerotherapy / 대한소화기내시경학회지

Endoscopic injection sclerotherapy is an effective and relatively safe modality for controlling bleeding esophageal varices. Injection of sclerosant causes acute mural thrombosis with a necroinflammatory response and subsequent sclerosis in the venous system of the distal esophagus. A few cases of mesenteric venous thrombosis with small bowel infarction after sclerotherapy have been reported, and most of which were fatal. The association between mesenteric venous thrombosis and sclerotherapy has been strongly suggested, but this still remains unproved. We report here on a case of mesenteric venous thrombosis with small bowel infarction that developed after endoscopic injection sclerotherapy.

A Case of Mucosal Necrosis of the Stomach after Endoscopic Injection Therapy with Hypertonic Saline-Epinephrine (HS-E) for a Bleeding Peptic Ulcer with an Exposed Vessel / 대한소화기내시경학회지

Peptic ulcer bleeding is a frequent cause of upper G-I bleeding. Endoscopic injection therapy with hypertonic saline-epinephrine (HS-E) is a cost-effective and widely used therapy for hemostasis; however, 1~3% of patients experience bleeding or perforation. A 70 year-old male patient was admitted with melena and hematemesis. An endoscopy on admission showed the presence of a 1 cm- sized well-demarcated ulcer with pulsatile bleeding at the lesser curvature of the distal antrum. Approximately 28 mL of HS-E solution was injected around the exposed vessel. Follow-up endoscopy performed 7 days later showed the presence of a 2 cm-sized newly developed mucosa necrosis at the lesser curvature of the pyloric channel, which was caused by ischemic necrosis of the gastric mucosa after HS-E injection. Endoscopic injection therapy with HS-E solution is a relatively safe technique, but mucosa necrosis can occur with the use of a dose of HS-E that is considered safe. We report a case of gastric mucosa necrosis following endoscopic HS-E injection therapy of a bleeding peptic ulcer.

A Case of Bleeding from a Periampullary Duodenal Varix that Developed after Biliary Metal Stent Placement in a Patient with Pancreatic Cancer / 대한소화기내시경학회지

Duodenal varices bleed less commonly than gastro-esophageal varices in patients with portal hypertension. However, if there is no stigmata of recent esophageal or gastric variceal bleeding, clinicians should suspect the presence of an extra gastro-esophageal site of variceal bleeding. Duodenal variceal bleeding can be difficult to diagnose and treat. Therefore, the bleeding may be life threatening in most cases and has a poor prognosis. We experienced a case of variceal bleeding that developed in a patient with far advanced pancreatic cancer after placement of a self- expanding metal stent into a strictured bile duct via the peroral and transpapillary route. The patient had a duodenal varix near the major papilla and the bleeding was treated with an injection of Histoacryl(R). We thought the bleeding of the periampullary varix resulted from injury due to exposure to the free end of the alloy wires in the distal portion of the inserted biliary metal stent.

Duodenal Variceal Bleeding Treated with a Combination of Endoscopic Ligation and Injection Sclerotherapy: Two Case Reports and a Review of the Korean Clinical Literature / 대한소화기내시경학회지

A duodenal varix is a rare cause of hemorrhage in patients with intrahepatic and extrahepatic portal hypertension. However, bleeding in these patients is serious and often life threatening. Treatments for duodenal variceal bleeding include endoscopic injection sclerotherapy, endoscopic ligation, surgical procedures and interventional radiology. We report two cases of duodenal variceal bleeding in a 53- year-old male patient and a 63-year-old female patient with liver cirrhosis that presented with hematemesis and melena. Emergency upper endoscopy examinations revealed the presence of large nodular varices with ruptured erosion on the top of the second portion of the duodenum. A combination of the use of endoscopic ligation and endoscopic injection sclerotherapy was performed and successful hemostasis and eradication of duodenal varices was possible in all cases. Another 19 cases of duodenal variceal bleeding that have been reported in the Korean clinical literature were reviewed.

A Case of Successful Endoscopic Injection Sclerotherapy with N-butyl-2-cyanoacrylate for Ruptured Duodenal Varices / 대한소화기학회지

Duodenal varix is a rare cause of hemorrhage in patients with portal hypertension, however their rupture is serious and often life threatening. Treatments for duodenal variceal bleeding include endoscopic procedures, surgery, or interventional radiologic procedures. We report a case of duodenal varices rupture in a 45-year-old man with alcoholic liver cirrhosis who presented with melena and dizziness. Emergent upper endoscopy revealed large nodular varices with a ruptured erosion on the top in the distal second portion of duodenum. Two consecutive injections with 1.0 mL of n-butyl-2-cyanoacrylate (Histoacryl; Braun-Melsungen, Germany) mixed with 1.0 mL of lipiodol (Laboratoire-Guerbet, France) were performed intravariceally and achieved successful hemostasis. This suggests that endoscopic injection sclerotherapy with histoacryl may be an effective therapeutic option for the control of ruptured duodenal variceal bleeding.

Comparison of Hemostatic Effects between a Combination Therapy Including Endoscopic Injection Therapy and Omeprazole and a Single Intravenous Omeprazole Therapy in Patients with Bleeding Peptic Ulcers / 대한소화기내시경학회지

BACKGROUND/AIMS: This study was performed to test whether there is some difference between combined endoscopic therapy with PPI infusion and intravenous PPI therapy alone. METHODS: A total of seventy-three high-risk patients with ulcer bleeding and non-bleeding visible vessels or fresh adherent clots resistant to irrigation were randomized to medical therapy [intravenous omeprazole therapy alone: 40 mg IV per day for 3~5 days] or to endoscopic combination therapy [endoscopic epinephrine (1 : 10,000 in normal saline) or ethanol injection followed by intravenous omeprazole infusion]. RESULTS: Patients were similar at study entry. Ulcer bleeding recurred in two patients who received combined endoscopic therapy (2/35, 5.7%) while ulcer bleeding recurred in ten patients who received intravenous omeprazole alone (10/38, 26.3%) (p < 0.05). Two patients (2/35, 5.7%) in the combined therapy group and five patients (5/38, 13.2%) in the omeprazole infusion alone group had surgery for intractable bleeding (p=0.281). One patient in each group died within the hospital stays (p=0.953). CONCLUSIONS: The combination of endoscopic injection therapy with omeprazole infusion is superior to omeprazole infusion alone for preventing recurrent bleeding from ulcers with nonbleeding visible vessels or adherent clots.

Changes in portosystemic collaterals after endoscopic injection sclerotherapy: focused on magnetic resonance angiography / 대한내과학회지

BACKGROUND: This study was aimed at evaluating the changes of collateral circulation, using MR angiography (MRA), which is a non-invasive and a useful tool for viewing the porto-systemic circulation as a whole, following endoscopic injection sclerotherapy (EIS). METHODS: 30 patients who have portal hypertension with esophageal varices have taken MRA before the sclerotherapy and followed up 1 month after the eradication. RESULTS: The collaterals observed before EIS are as follows: left gastric vein 30 patients (100%), short gastric vein 2 patients (7%), gastro-renal shunt 2 patients (7%) and spleno-renal shunt 6 patients (20%). After the sclerotherapy, left gastric vein was obliterated in 12 patients (40%), decreased to 25% and 50% in 9 patients (30%) but, no change in 6 patients (20%), increased in 3 patients (10%). For short gastric vein, 25% and 50% size reduction was found in 2 patients. For gastro-renal shunt, no change in size was observed in 1 patient, increased to 25% in 1 patient. For spleno-renal shunt, it disappeared in 1 patients (17%) and decreased to 25% in 1 patient but, no change in 3 patients (50%), increased to 25% in 1 patients. CONCLUSION: Obliteration of left gastric vein was observed in many cases after the sclerotherapy and further evaluation is needed.

A Case of Successful Endoscopic Injection Sclerotherapy with N-butyl-2-cyanoacrylate for Bleeding Duodenal Varices Misdiagnosed Initially / 대한소화기내시경학회지

Duodenal varices are a rare site of hemorrhage in patients with intrahepatic and extrahepatic portal hypertension, but their bleeding is life-threatening complication. Diagnosis of duodenal varices may be difficult, requiring careful inspection of the duodenal bulb during endoscopy. Diagnosis of duodenal varices may also be revealed using angiography and transhepatic portography. Treatment of duodenal varices include endoscopic injection sclerotherapy (EIS), endoscopic variceal ligation (EVL), surgical procedures, and interventional radiology. A 50-year-old woman with liver cirrhosis was admitted with melena and hematochezia. An endoscopy on admission showed esophageal and fundal varices without any bleeding stigma. Colonoscopy showed moderate amount of fresh blood in the terminal ileum. 99mTc-labelled RBC scan showed a suspicion of a distal jejunal bleeding. She had explo-laparotomy of small bowel segmental resection based on 99mTc-labelled RBC but rebleeding occured. Selective mesenteric angiography failed to reveal the source of bleeding. Repeat endoscopy revealed undetected duodenal varix which was covered with fresh blood clots. Endoscopic injection sclerotherapy with n-butyl-2-cyano acrylate (Histoacryl) was performed and achieved succesful hemostasis.

A clinical study of endoscopic band ligation in the treatment of hemorrhage due to Dieulafoy lesions / 中华消化杂志

0.05),but the rate of recurrent bleeding in EBL group was significantly lower than that in EIS group (6.3% vs. ~40.0% , P0.05). Conclusions EBL is an effective and safe ~endoscopic treatment for hemorrhagic Dieulafoy's lesion.