| Background and Objective:In recent years,endoscopic submucosal dissection?ESD?,a new endo-luminal therapeutic technique that enables the en bloc resection of lesions,has increasingly been used to treat early esophageal cancer[1-3]and submucosal tumors of the gastrointestinal tract[4,5].ESD is superior to conventional endoscopic mucosal resection?EMR?in terms of its en bloc resection rate and local recurrence rate[2,6-8].Despite the advantages of ESD,it remains a challenging technique because it is usually difficult to obtain a good view of the dissection,and this technique is time-consuming and associated with a higher rate of complication,such as perforation and bleeding[6,9,10].Esophageal ESD is particularly difficult because the esophageal lumen is narrow and the esophageal wall is thin,resulting in complications,such as perforation and pneumomediastinum[11].Submucosal evection such as heterotopic pancreas?HP?ESD is also difficult.Because it usually invade muscle layer,although it is submucosa origin,it is often difficult to maintain appropriate visualization during submucosal dissection.Therefore,new concepts have been devised to facilitate the ESD procedure,the traction method has been used in attempts to overcome this problem.The treaction methods include clip with thread traction method,external grasping forceps method,internal traction method,double scope method and so on.Traction methods are essentially used to facilitate the visualization of the submucosal layer,which enables the accurate identification of the cutting line and submucosal vessels[12],the traction methods can reduce bleeding and perforation of ESD.But some traction methods are with the disadvantages of invasiveness,complexity,interference and so on,which are not widely used in clinic.So we should found a simple,safe,non-invasive,and uses readily available instruments to enhance the field of vision of ESD.The clip-line traction is with the above advantages which is only need a line and a clip.Recently,although some studies have reported that the clip-line traction technique is useful for improving the field of view during ESD[13-16],there are a few reports regarding the application of traction using a clip to the treatment of early esophageal carcinoma and heterotopic pancreas?HP?.Therefore,in this paper,we retrospectively analyzed the clinical data of 113 patients with EEC or precancerous lesion from March 2014 to June 2015 and 58 patients with gastric HP from May 2013 to February 2016 who were underwent ESD in our hospital.They were divided into two groups?clip group and non-clip group?,we observed the dissection time,the complication of ESD and so on.The aim of our study was to assess whether clip traction contributes to increase safety and shorten the duration of ESD when it was used during the early phase of esophageal and gastric submucosa evection ESD.1.Clinical Data and Methods1.1 Clinical DataInitially,a total of 113 EEC or precancerous patients from March 2014 to June 2015who were treated with ESD at the endoscopic center of Xinqiao Hospital of the Third Military Medical University?Chongqing,China?were studied.According to the rule of a1:1 case-control design,we matched the size of the lesion,the age?up to 5 years old or younger?and the gender of patients,At last 100 lesions were ultimately enrolled in this study.Fifty cases underwent ESD without clip traction?non-clip group?,and 50 cases underwent ESD with clip traction?clip group?.58 patients with gastric HP who were treated by ESD and diagnosed gastric HP by pathology after ESD in Xinqiao Hospital of the Third Military Medical University from May 2013 to February 2016 were belonged to HP group.Endoscopic ultrasonography?EUS?was performed preoperatively using a UM-2000 system?Olympus Optical,Tokyo,Japan?to evaluate the origin and size of the tumors.They were also divideed into clip group?32 cases?and non-clip group?26 cases?.All endoscopic procedures were performed by the expert endoscopists with nearly the same levels of experience.The information that was collected and analyzed included the lesion type,location,size,dissection time,bleeding and the injury of muscularis propria etc.The detailed clinicopathological features of all of the patients are summarized.1.2 method1.2.1 SedationContinuous infusion of propofol and remifentanil was used for sedation,and midazolam that was also given as an sedative.The depth of sedation,circulatory suppression and respiratory suppression were evaluated by an anesthesiologist.Regarding the depth of sedation,moderate to deep sedation according to the ASA classification was used as an index[17-20].1.2.2 ESD proceduresIn EEC group,the lesions were detected by white-light endoscopy and narrow-band imaging combine with Magnified Endoscopy?NBI-ME?to estimate the depth and extent of the invasion before ESD.Before marking,iodine staining was performed using 1.5%Lugol's solution to further identify the lateral margins of the lesion.Circumferential marking was accomplished with the hook knife or Argon knife in the forced coagulation mode of the generator at 5mm outside of the tumor margin,The VIO200D and APC-ICC200?ERBE ELEKTROMEDIZIN GMBH,Germany?were set in the forced coagulation mode?effect 2,output 40W?to incise the mucosa.Before the circumferential mucosal incision,a solution of 40ml 0.9%sodium chloride,2.5ml sodium hyaluronate and 0.5ml methylene blue was injected into the submucosal layer to elevate the lesion.The circumferential mucosal incision was performed at 5mm outside of the marking with a hook knife in the endocut mode?setting effect 3,duration 2,interval 4?.Then,dissecting the submucosal layer under endcut mode.At last,wound hemostasis and dispatching the specimens to the pathology department,The ESD procedure using the thread traction method performed as follows:first,after the circumferential mucosal incision,A‘clip with a string'was assembled by attaching a string to a marking clip?HX-600-090;Olympus,Tokyo,Japan?for the clip group.The thread was tied to the proximal claw of the clip,and the clip with thread was then attached to a rotatable clip-fixing device;second,the clip with a string was clamped to the oral edge of the lesion's submucosa;third,the string was pulled in the oral direction by an assistant to place traction on the submucosal layer;and finally,the submucosal layer was removed away from the muscle layer with a hook knife or an insulated-tip knife-2 knife.To control bleeding during the ESD procedure,hemostatic forceps?FD-411QR;Olympus?were used in the soft coagulation mode?Effect 5,60W?.Each patient was sedated via the continuing intravenous injection of propofol?7-8mg/kg.h?and remifentanil?3.5ug/kg.h?,and additional 3mg of midazolam was given as needed for sedation throughout the ESD.Insufflation with carbon dioxide?CO2?was performed and closing operation wound with clips when the muscularis propria was injuried.The resected specimens were retrieved to complete the procedure.In HP group,most of lesions were detected by Miniprobe Sonographto?MPS?to estimate the size and origin of HP before ESD.The other procedure of ESD is the same as EEC ESD,which include marking,circumferential mucosal incision,submucosal dissection,wound surface and specimen management.Purse-string suture was performed with clip and nylon rubber band when perforation occurred.Written informed consent was obtained from all patients before the operation.All ESD procedures were performed by endospic experts who specialized in ESD,and each of them has done more than 200 cases per year since 2013.1.2.3 Clips with threadsThe clip with thread was composed of a rotatable clip releaser?Olympus Medical Systems,Corp?,a clip?HX-610-090S;Olympus Medical Systems,Corp?and a thread?approximately 2m in length?.The thread was tied to the claw of the clip after the circumferential mucosal and the oral edge of the lesion's submucosa incision,and the clip with the thread was then attached to a rotatable clip-fixing device.1.2.4 AssessmentThe ESD dissection time was defined as the time from the accomplishment of the marking around the lesion to the end of the prophylactic hemostasis of the resected area.In the clip group,time was needed to attach a clip with thread and grasp the specimen with it,and this time was also included in the dissection time.The data regarding bleeding,perforation and muscle layer injuries during the procedure and the complications after the procedure of ESD were recorded.Moreover,the pathology results were statistically analyzed after the operations.1.3 Statistical AnalysisThe SPSS 20.0 statistical software was used for data processing.Means and standard deviations?SDs?were used to describe normally distributed values,and independent samples t tests or t,tests were used to compare the differences between the two groups;Medians?interquartile ranges,IQRs?or Medians?P25,P75?were used for variables with skewed distributions,and rank sum tests or nonparametric Mann-Whitney U test were used to compare the differences between the two groups.Count data are reported as n?%?,and the?2-test or fisher,s accurate probability test were used to analyze the differences between the two groups.P<0.05 indicated a significant difference.2.Results2.1 Clinical features of the two groups before treatmentAmong the consecutive patients who were diagnosed with EEC or a precancerous lesion via upper gastrointestinal endoscopy at our hospital,all of the patients with lesions that were scheduled for treatment with esophageal ESD were enrolled.50 lesions were assigned to the clip group,and 50 lesions were assigned to the non-clip group.ESD was successful in all lesions.There were no statistical difference between clip group and non-clip group before treatment in terms of age?63.46±8.91 years vs 61.00±8.12 years,P=0.152?,gender?37 males and 13 females vs 35 males and 15 females,P=0.656?,longitudinal diameters[4.30?2.00?cm vs 4.00?2.07?cm,P=0.814),transverse diameter[2.90?1.23?cm vs 2.55?1.50?cm,P=0.289]or the macroscopic type?P=0.117?.The lesion locations were also not statistically different between two groups?P=0.355?;in the non-clip group,1?2.0%?case had a lesion in the upper esophagus,43?86.0%?cases had lesions in the middle esophagus,and 6?12.0%?cases had lesions in the lower thoracic esophagus.In the clip group,4?8.0%?cases had lesions in the upper esophagus,39?78.0%?cases had lesions were in the middle esophagus,and 7?14.0%?cases were in the lower thoracic esophagus.The circumferences of the ESDs were also not significantly different?P=0.229?.There were26?52%?lesions in non-clip group and 20?40%?lesions in clip group that were less than half the circumference of the esophagus.The patients who concurrently underwent multiple lesion resection were included in this study.A total of 58 HPs were resected by ESD during the study period.The selected patients had nonspecific clinical manifestations.32 lesions were assigned to the clip group,and 26lesions were assigned to the non-clip group.46 HPs were examed by EUS in our hospital before ESD,The EUS revealed all patients were submucosal layer origin.There were no significant differences between the two groups in terms of age?38.94±10.63 years vs40.69±12.81 years,P=0.571?,gender?21 males and 11 females vs 11 males and 14 females,P=0.136?,the longitudinal diameter?1.48±0.43cm vs 1.34±0.35cm,P=0.209?and the thickness of the lesions?0.81±0.29cm vs 0.78±0.29cm,P=0.778?)etc.There was no significant difference in umbilical depression at the top of the lesion between the two groups?50%vs 26.9%,P=0.074?.And the locations of HPs were also not different?P=0.185?.2.2 Dissection timeIn esophageal lesions,group,Regardless of the site or size of the lesion,we found that the dissection time was shorter in the clip group than in the non-clip group.The clip group tended to require less dissection time,but it was not significantly shorter than non-clip group[27.58?28.32?min vs 34.79?27.54?min,P=0.252].Nevertheless,when the lesions were less than half of the circumference of the esophagus,the dissection time was significantly shorter in the clip group than the non-clip group[22.02?6.77?min vs26.48?12.56?min,P=0.018].In contrast,there was no difference in dissection time when the lesion was more than half of the circumference of the esophagus[46.75?37.78?min vs51.82?57.38?min,P=0.223].In HP group,The dissection time of ESD was shorter in the clip group than in the non-clip group[17.20?12.21,29.51?min vs 29.32?15.93,43.44?min,P=0.048].2.3 Field of visionThe field of vision is very important in the ESD process.The field of vision might not be sufficient when the specimen was only fixed by the cap of the dissection.However,in the clip-traction group,a clip with a thread was attached the oral edge of the specimen after the circumferential mucosal incision.Then,the thread was pulled towards the oral side to fixed the lesion.Accordingly,an effective countertraction was acquired,a better field of vision was attained compared with the non-clip group.2.4 Complications and pathology AnalysisIn esophageal lesions,group,The results revealed that there were no complications of perforation,infection and requiring Blood transfusion during ESD procedure.Moreover,injury to the muscularis propria was obviously less frequent in the clip group than the non-clip group?10%vs 30%,p=0.007?.The pathologies were not significantly difference following ESD in two gtoups?P=0.748?.In the clip group,29?58.0%?lesions were high-grade intraepithelial neoplasias?HIGNs?,9?18.0%?lesions were low-grade intraepithelial neoplasias?LGINs?,8?16.0%?lesions were submucosal?SM1?carcinomas,and 4?8.0%?lesions were intramucosal?IM?carcinomas.In the non-clip group,31?62.0%?lesions were HIGNs,11?22.0%?lesions were LGINs,6?12.0%?lesions were SM1carcinomas,and 2?4.0%?lesions were IM carcinomas.The depth of lesion between clip group and non-clip group was also not statistically different?P=0.100?.In HP group,we found that the complication of bleeding during the procedure of ESD was obviously less in clip group than non-clip group?21.9%vs 50%,P=0.012?;But the perforation was not significant difference between the two groups?6.3%vs 7.7%,p=1.000?.No significant difference was found in the injury to the muscularis propria between the clip group and the non-clip group?53.1%vs 51%,P=0.817?.2.5 Follow upIn the group of esophageal lesions,The mean hospital stay were?5.84±1.82?days and?5.76±1.65?days respectively in clip group and non-clip group,There was no significant difference?P=0.818?.There were no complications of perforation,bleeding and infection after ESD during the follow-up period?17-36 months?.Esophageal strictures occurred in 3and 4 patients after ESD in clip group and non-clip group respectively,there was no significantly difference?P=1.00?,Patients with esophageal strictures were relieved by endoscopic balloon dilation?EBD?or combining triamcinolone acetonide injection.There were 6 and 3 cases with additional chemotherapy after ESD in clip group and non-clip group respectively,it was not significantly different?P=0.487?,and no recurrences after chemotherapy.2 patients with local recurrence underwented the second ESD treatment in the non-clip group.There was no death in both groups during follow-up.In HP group,the mean hospital stay was not significantly different in clip group and non-clip group[6.38±3.70 days vs 5.58±2.30 days,P=0.341).There was no delayed bleeding or perforation occurred during the follow-up period?10-43 months?,and no recurrences and death in any cases.Conclusion:Clip traction can decrease the rate of muscularis propria injury of EEC,shorten the dissection time,and reduce the rate of bleeding in the procedure of ESD.It is recommended as a safe and effective auxiliary procedure for the treatment of esophageal and Submucosal evection ESD. |
PDF Full Text Request