| Background With the development of endoscopic screening and surveillance,the detection rate is steadily increasing for precancerous lesions and early cancer in gastrointestinal tract.Endoscopic submucosal dissection(ESD)has been accepted as a minimal invasive alternative to surgery for localized superficial gastrointestinal neoplasms recently.China has a high incidence of gastric cancer and esophageal cancer.Gastric cancer is one of the most common malignant tumours and is the second leading cause of cancer death worldwide.In our country,the mortality rate of gastric cancer is the highest of all cancers.The number of patients with early gastric cancer and early esophageal cancer are increase than before and need treated by ESD procedure.ESD has been one of the principal methods used for the treatment of early digestive tract cancer and precancerous lesions.It has the advantages of providing a wider local excision,the possibility of obtaining en-bloc specimens with free lateral margins,maintaining the normal physiological structure and allowing an accurate determination of the depth of tumour invasion.ESD can achieve similar efficacy compared with surgery.Although clinical long-term outcome showed excellent results,ESD remains to be a technically challenging and time consuming procedure compared to other endoscopic resection methods including endoscopic mucosal resection(EMR).In addition to this,the incidence of complications include bleeding and perforation is higher in ESD.Modifications on devices and methods of ESD have been attempted.The Hybrid Knife,a new system which combines electrosurgical technology with a water-jet system(ERBEJET2;ERBE,Germany),allows rapidly injection of solutions into the submucosa to form a fluid cushion without exchanging instruments.It has been previously shown to be effective and safe in animal studies and clinical trials.Hybrid Knife include three types,I-type,T-type and O-type.O-type Hybrid Knife is a new type of Hybrid Knife was developed with a partially insulated tip.It contains an insulated tip except for the center where the metal needle tip for injection went through.The Hybrid Knife can perform procedure involved marking,injection,circumferential cutting,submucosal dissection and hemostasis.The IT2 knife was the most commonly used dissecting knife in ESD procedure and shared similar design with the O-type Hybrid Knife.However,little was known if the built-in injection capability would help to reduce ESD procedure time,in addition to this,the injury degree of muscularis propria was unknown.Aims 1.In the present study,we conducted a randomized,controlled prospective study to compared the procedure time,adverse events and treatment outcome between Hybrid Knife ESD and conventional ESD.The purpose of this study was to evaluate the efficiency of O-type Hybrid Knife in gastric mucosal lesions compared to conventional IT2 ESD knives.2.A single center,retrospective study was performed on data of patients with esophageal superficial neoplasms who treated by convetional ESD or ESTD with Hybrid Knife.The purpose of this study was to evaluate the safety and efficiency of O-type Hybrid Knife.3.Conduct a single center,observational study to evaluate the degree of damage to the muscularis propria of the surgical bed in vitro pig stomach.Methods 1.From January 2013 to September 2014,78 consecutive patients with eligible gastric lesions were recruited at Xijing Hospital of Digestive Diseases.The enrolled patients included gastric flat type adenoma/polyps,biopsy confirmed early differentiated adenocarcinoma and high-grade intraepithelial neoplasia.The patients who met the inclusion criteria and did not have any of the exclusion criteria were randomly allocated 1:1 to either the IT knife group or the Hybrid Knife group.Procedure time,related factors of ESD and complications were analyzed.2.A total of 113 consecutive patients with esophageal superficial neoplasms cases treated by endoscopy between January 2014 and December 2016 at Xijing Hospital of Digestive Disease were retrospectively reviewed.Lesions treated by conventional ESD and ESTD with O-type Hybrid Knife.The procedure time,lesion size,pathology,treatment outcome and adverse events were recorded.3.A total of 18 areas of the antral and posterior mucosa in three pig stomach with a diameter of 2cm2(6 per stomach)were marked by Dual knife,and resected by the O-type Hybrid Knife.Each surgical bed was sequentially sectioned and submitted in total for paraffin block embedding and sectioning after staining with hematoxylin and eosin.The degree of damage to the muscularis propria,incidence of perforation and en-bloc resection rate were recorded.Results 1.ESD procedure time was 43.0(interquartile range,IQR 27.0–60.0)minutes in Hybrid Knife group compared to 60.5(IQR 44.0–86.3)minutes in the control group(P= 0.001).There was no difference in the clinical outcome and the adverse event rate.The former demonstrated more favorable results in lesions ≤4cm of specimen size(P≤0.0001)and when located in the distal stomach(P=0.001),also in lesions with fibrosis(P=0.008).Multivariate regression analysis showed that O-type Knife(P ≤0.0001),specimen size(P≤0.0001),and fibrosis(P≤0.0001)were independent predictors of procedure time.2.A total of 113 consecutive patients undergoing ESD or ESTD for esophageal superficial neoplasms in our hospital were analyzed retrospectively.The totally procedure time was 39.0(21.4-117.5)min.The en-bloc resection rate was 100% and the curative resection rate was 95.6%.No perforation in all patients.35 patients showed muscular injury during operation.The bleeding rate during operation was 29.2%.1 patient occurred post-procedure bleeding.9 patients with fever and 14 patients with thoracalgia after operation.One patient occurred esophageal stricture after operation and placed the esophageal stents.According to the pathology findings,the pathological stage of tumer as follows: pathological stage of 12 cases was p T1 b.7 of these patients conform to the curative recetion criterion because the depth of invasion was SM1.Depth of invasion was SM2 in one patients and SM3 in 2 patients.Tumor residual in 2 patients and additional surgery were performed.Follow-up for 11-36 months,2 patients occured lymph node metastasis or recurrence.No death associated with primary disease.3.A total of 18 areas of the antral and posterior mucosa in three pig stomach were resected by ESD with O-type Hybrid Knife.Piecemeal resection was conducted in one case due to poor fluid cushion in submucosal layer.The en-bloc resection rate was 94.4%.Histological evaluation were performed in each surgical bed.During the ESD procedure,4 cases(22.2%)occured muscular injury and observed by endoscopy.The degree of damage to the muscularis propria was mostly in superficial part.Conclusions 1.The O-type Hybrid Knife yielded faster procedure time compared to the conventional knives in gastric ESD with a similar safety profile.2.ESD and ESTD by O-type Hybrid Knife is a safe and effective alternative for esophageal superficial neoplasms.The Hybrid Knife had excellent treatment outcome and shorter operative time.Furthermore,it can reduce injury to muscular layer and decrease the rate of other adverse events.3.In the model of vitro pig stomach,the O-type Hybrid Knife was used for ESD surgery,with a higher en bloc resection rate,no increase of perforation rate,and less damage to the muscularis propria of surgical bed. |
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