| Background:Gastric submucosal tumors(SMTs)are mesenchymal tumors and as such,they may have very diverse origins.SMTs were originally divided into being of muscular or neural derivation.That SMTs smaller than 30mm are considered benign tumors generally.The number of mitotic counts allowed for benign SMTs varies among the different SMTs.Such benign submucosal tumors mainly include leiomyoma,schwannoma,granulosa cell tumor,ectopic pancreatic tissue,lipoma,neurofibroma and hemangioma.SMTs larger than 30mm,with mitotic counts greater than 2 per 10 high power fields or that involve more layers are generally considered high-risk tumors for malignancy.Malignant Gastric submucosal tumors include:leiomyosarcoma,gastrointestinal Kaposi sarcoma,malignant tumor gastrointestinal metastasis and gastrointestinal stromal tumors.Submucosal tumor can occur in all parts of the digestive tract,up to the esophagus,down to the anus has case reports.The vast majority of SMTs occur in the stomach,such as GIST in the stomach about 46%incidence.Some of the SMTs that occur in the stomach lack clinical signs and most are found by chance for endoscopy or other imaging studies.More SMTs patients only partial non-specific symptoms such as:stomach upset,nausea,bloating,anorexia,indigestion and so on.Unless the tumor fester,hemorrhage or grow enough to cause pain or blockage.Gastric submucosal tumor diagnosis mainly depends on imaging studies such as Contrast-enhanced computed tomography(CE-CT)and magnetic resonance imaging(MRI).Endoscopy such as conventional endoscopy and endoscopic ultrasonography(EUS)has a certain role in the identification of gastric SMTs.Preoperative endoscopic ultrasonography is necessary to assist in assessing lesion information and providing more information for surgical options.Ultrasound endoscopic guided biopsy,Endoscopic ultrasound-guided fine needle aspiration(EUS-FNA),and Endoscopic ultrasound-guided fine needle biopsy(EUS-FNB)were performed under the guidance of ultrasound endoscopic technique that has been used in the diagnosis of SMTs.Although the above method of gastric submucosal tumor diagnosis and differential diagnosis is very helpful and can provide evidence for the identification of benign and malignant tumors,the final diagnosis can only rely on postoperative histological examination.It is so important that make a good choice on timing of surgical approach.Gastric mucosa due to the surface of the tumor covered by normal mucosa,manifested as bulging lesions,it is difficult to obtain endoscopic biopsy to confirm the pathological diagnosis of tumor tissue.Conventional laparotomy or laparoscopic resection for a larger submucosal mass is the most effective method of treatment.Endoscopic treatment is mainly used in patients with smaller SMTs(<20mm),of which endoscopic submucosal dissection(ESD)has a better operative effect and less risk for gastric SMTs 1-2cm in diameter,Is now the standard treatment for endoscopic treatment of gastric SMTs.At the same time,other endoscopic tumor resections based on this technology have also been gradually developed and applied to clinical such as ESTD,ESD-based EFTR technology.However,for smaller diameter gastric SMTs(<10mm),ESD and related technologies are overly complex and difficult to operate,and therefore cap-assisted endoscopic full thickness resection(Cap-EFTR)is also known as Cap-aspiration lumpectomy(CASL)is developed and applied to clinic by endoscopic physicians in our hospital.It has the advantages of simple operation,short operation time and high resection complete rate for gastric submucosal tumors less than 10mm in diameter.Currently,there are many studies on submucosal lesions of the upper gastrointestinal tract,but there is no uniform treatment standard for submucosal tumors<10 mm in diameter.However,in our clinical practice,patients often have a strong and active desire to remove their SMTs.Considering that nearly 40%of gastric SMTs are gastrointestinal stromal tumors(GIST),the tumor has the potential to malignant transformation regardless of size.With the development of endoscopy technology,the risk of endoscopic resection of submucosal tumors with smaller diameters is getting lower and lower.We are also more inclined to take a more active treatment.However,with the popularization and application of Cap-EFTR technology,we also found that there are some potential risks of intraoperative and postoperative.This study is a retrospective analysis of the cases of Cap-EFTR resection of gastric SMTs less than 10mm in diameter,and summarizes the potential risks of this surgery and comparing them with the traditional EBL procedure.At the same time,a new improvement scheme is put forward on the basis of its characteristics.Chapter 1 Cap-assisted endoscopic full-thickness resection for small gastric submucosal tumors:a retrospective studyObjective:For smaller gastric submucosal tumors,endoscopic submucosal dissection(ESD)and endoscopic full-thickness resection(EFTR)are generally used for resection of the tumor.In our country,SMTs patients usually have a positive treatment attitude towards themselves(that is,they hope to completely remove the tumor).Therefore,for SMT with a diameter of less than 2 cm,endoscopic treatment is a less traumatic and risky treatment for patients without related contraindications.Currently,endoscopic band ligation(EBL),endoscopic submucosal resection(EMR),endoscopic submucosal tunnel dissection(ESTD)and endoscopic full-thickness resection(EFTR)are commonly used to treat the lesser-diameter gastric submucosal tumors.According to previous literature reports,ESD is most suitable for the treatment of stomach SMT in a variety of endoscopic resection techniques.In clinical practice,ESD and ESD based EFTR are effective endoscopic resections for gastric tumors ranging from 10 mm to 20 mm and larger.However,for less than 10 mm of stomach SMTs,ESD or ESD based EFTR appears to be complex and difficult to operate.Cap-assisted endoscopic full-thickness resection is commonly used to treat gastric SMTs less than 10 mm,based on the convenient and ease for operation.However,in the next few years,we will apply this method to clinical practice on a large scale and find some problems at the same time.In this study,we aimed to reassess the safety of cap-assisted EFTR for the treatment of gastric SMTs smaller than 10 mm,describing their potential risks and comparing them with the traditional EBL procedure.Methods:This retrospective study collected clinical data from 5746 patients diagnosed with primary gastric submucosal mass in our hospital from June 2006 to June 2017.437 patients received endoscopic resection of submucosal tumor of the stomach.however,only 227 patients met the inclusion criteria for this study and were eventually added to the study.This study collected demographic and clinical data including age,gender,clinical manifestations,tumor location,tumor size and pathological findings.The recorded surgical details include:operation time,resection status,resection depth,estimated intraoperative blood loss,suture method,average length of stay after operation,average length of stay,hospitalization expenses,intraoperative complications,postoperative complications.And the above information for statistical description and analysis.All those undergoing Cap-EFTR or EBL were experienced endoscopists and underwent surgery following the standard methods described in previous studies.All patients have been completed related tests after admission,suspension of antiplatelet or anticoagulant drugs(such as aspirin)for more than 1 week,and no surgery-related contraindications.All patients were informed of the benefits and risks of the surgical treatment before the operation,and a written informed consent was signed before the operation.The classification data in this study is expressed in the form of a count.Continuous variables are expressed as mean and standard deviation or median and range.The categorical data between two groups were statistically analyzed by the chi-square test,while the continuous variables were statistically analyzed by two independent samples T-tests.The grading data were statistically analyzed by the Wilcoxon rank-sum test.Disease-free survival was analyzed by the Kaplan-Meier test.All statistical analyses in this study used Microsoft Excel 2016 and SPSS 20.00(IBM,Armonk,NY,USA).All statistical results were considered statistically significant when the P value was less than 0.05.Results:This study included 100 patients with gastric SMT.There were 36 males and 64 females.The average age of 100 patients was 51.1± 10.9 years(18 to 74 years).The main clinical symptoms are:1.43 cases of abdominal pain,has been mild or intermittent abdominal pain;2.abdominal distension in 24 cases;3.nausea and vomiting in 7 cases,of which diarrhea mainly for the realization of mild diarrhea,up to 15 times a day,At least 6 times,of which 4 cases were colonoscopy found to be colorectal polyps;4.No obvious symptoms in 26 cases.There was no significant difference in age and sex between Cap-EFTR and EBL groups,but there was some difference in clinical performance and statistical significance.All patients included in this study were carried out at least once in the preoperative ultrasound endoscopy.Ultrasound endoscopy rate of 100%.Of all Cap-EFTR group patients included in this study,87 were located in the fundus,10 were located in the corpus,and 3 were located in the antrum.The average diameter of tumors was 8.3 ± 1.9(4-12).The vast majority(93 cases)of tumors between the size of 5-10mm.97%of SMT cases originated in the muscularis mucosa and none of the 100 cases found SMTs that originate in the muscularis propria.The 100 SMT patients included in this study showed no surface depression or ulceration of the tumor.In the pathological diagnosis,there are 57 cases of GIST,of which 49 cases of very low risk and low risk in 8 cases,no medium or high risk patients.There are 31 patients with leiomyoma.It is noteworthy that two patients were diagnosed as unidentifiable spindle cell tumor,followed by immunohistochemistry to determine an example of granular granular tumor,another one is leiomyoma.Compared with the EBL group,there was no significant difference between the two groups in the level of tumor origin,tumor size,tumor location,and tumor surface conditions.However,in the effective biopsy rate,the Cap-EFTR group was much higher than the EBL group and there was a statistical difference.The mean duration of Cap-EFTR surgery seen in this study was 17.2 ± 9.9(10-73)minutes with an average duration of surgery of 30.0 ± 9.3(20-45)minutes in patients with complications,with no complications the average duration of surgery in patients was 16.1 ± 9.2(10-73)minutes.Among them,95 patients achieved complete resection of the tumor,and 5 patients were unable to determine the complete resection due to the special location of the tumor or intraoperative bleeding.However,all patients were confirmed complete resection in the follow-up.72 patients resected to a depth of serosa or full thickness resection,only 28 patients had resection depths reaching the muscularis propria.The estimated intra-operative mean hemorrhage is 33.9 ± 127.6(1-1000)ml,with no arterial hemorrhage bleeding was only 3.2 ± 1.8(1-15)ml,with an average of 387.5 ± 273.5(100-1000)ml in cases of arterial active hemorrhage.In the event of an arterial hemorrhage,the maximum amount of blood loss may be as high as 1000 ml.95 of these patients underwent titanium clip suturing while 5 received OTSC stapler closure wounds.However,we observed intraoperative arterial bleeding in 8 patients and severe complications after surgery in 6 patients(2 infections and 4 bleeding).In 8 cases of patients with arterial hemorrhage,titanium clips were occluded in 5 cases and clipping failed in 2 cases.A case of bleeding which can't stop bleeding until receiving embolization to stop bleeding.Of the 6 patients with postoperative complications,4 recovered after endoscopic hemostasis,blood transfusion,anti-shock or anti-infective therapy.However,2 patients underwent emergency surgery because of serous hemorrhage and intraperitoneal hemorrhage.It is noteworthy that,SMT patients often have serious complications in the stomach fundus and use of OTSC system closure wound or perforation with no postoperative complications.In addition to the above-mentioned active bleeding,2 patients even experienced antibiotic treatment with body temperature exceeding 38 ? or C-reactive protein 10 times above normal for at least 3 days.Fortunately,all intraoperative and postoperative complications(14 cases,14%)were promptly detected and treated properly,and finally all recovered and discharged.The average length of stay was 8.9 ? 2.8 days(4-19 days).In the EBL group,there were only 3 cases of postoperative complications.In 1 case,due to deep excavation biopsy during the operation,the rubber ring was prematurely detached and delayed hemorrhage occurred.Endoscopic active hemostasis and active treatment resulted in rehabilitation of the patient.Premature detachment of the tumor occurred and perforation occurred.After endoscopic perforation repair and active anti-infective treatment,the patient was discharged.There were no cases of surgically related deaths in either group.Compared with the two groups,there was no statistically significant difference in the operation time,average hospital stay,and hospitalization costs.However,there was a significant difference in the estimated bleeding volume and complication rates during surgery and it was statistically significant.In follow-up data,32 patients were effectively followed in the Cap-EFTR group.The average follow-up duration was 22.8 ± 9.5(6-42).In the EBL group,42 patients were effectively followed up.The follow-up duration was 27.8.± 10.6(11-49),there was a statistically significant difference in the mean follow-up time between the two groups.The tumor recurrence rate was 2/32(6.2%)in the Cap-EFTR group and 5/42(11.9%)in the EBL group.Although there are some differences,but the difference is not significant,the disease-free survival analysis of the two groups found that the P value was greater than 0.05,there was no significant statistical difference.Conclusions:This study shows that the use of Cap-EFTR as an endoscopic resection technique for the treatment of gastric SMTs less than 10 mm in diameter is an effective and easy-to-use method,but with associated high intraoperative and postoperative risk(14%).The main reason for the higher risk of SMTs in the stomach fundus may be the presence of a rich vascular network in the fundus.At the same time,there was no postoperative complications when the surgical wounds were closed using the OTSC anastomosis system.Based on this,we designed and proposed a new OTSC-assisted resection device and combined it with the traditional Cap-EFTR procedure,which is expected to become a new safe and effective method for the treatment of small gastric submucosal tumor.Chapter 2 Improvements and New Applications for the Existing OTSC System-A New OTSC System for Multifunctional OTSC Release Caps(Inventions)Objective:At present,the system OTSC release cap only has one function of releasing OTSC clips,witch can not meet the clinical needs of existing endoscopic physicians.For resection of the tumor,the existing release cap needs to be installed after the resection of the tumor to release the OTSC clip because of the mounting structure of the existing release cap without a supporting high-frequency electric knife and its corresponding snare.Therefore,it has the process of refraction and secondary into the endoscopy during this period,increasing the incidence of surgical complications,which undoubtedly increased the surgeons and patients need to bear the risk.Content:The technical problem to be solved by the present invention is to provide a multifunctional cap for OTSC anastomosis system,which allows the endoscopist to directly release the OTSC anastomosis clip to close the wound after the resection and other operations are completed,thereby reducing the complications of surgery.To solve the above technical problems,the present invention adopts the following technical solutions:A multi-purpose release cap for an OTSC anastomosis system includes a tubular body having an outer ring at one end and an outer ring for use with an OTSC anastomosis system fit the inner ring,the outer ring and the inner ring form an anastomotic clip set slot,the slot of the anastomotic clip set slot faces the end face of the end of the main body,the end of the outer ring on the slot side is provided with a slot for the nylon.The first threading hole through which the rope passes is provided with a second threading hole for the nylon rope to pass through,corresponding to the first threading hole in the inner ring,and the front end of the inner wall of the inner ring is provided with a ring of annular protruding wall The utility model is provided with an annular groove and an axial groove for fixing a high-frequency electric knife or a snare.One end of the axial groove is communicated with the annular groove and the other end is flush with the inner end surface of the annular convex wall to form a sliding inlet.The other end is provided with a connector ring for fitting with the mounting end of the soft digestive endoscope in the OTSC fitting system.Meanwhile,the end surface of the outer ring on the side of the notch is provided with an axially protruding fixing plate,and the first threading hole is opened on the fixing plate.The outer wall of the connecting ring is provided with an identification convex block corresponding to the position of the axial groove.The length of the outer ring is less than the length of the inner ring.The inner wall of the connecting ring is provided with an annular non-slip pattern.The width of both the annular groove and the axial groove is 2 mm.The distance between the annular groove and the end face of the inner ring is 1 mm.Compared with the prior art,the present invention has the following advantages:The present invention can fix the high-frequency electric knife or the snare through the annular groove and the axial groove on the inner wall of the inner ring,and can also fix the high-The second threading hole to wear nylon rope to release OTSC anastomosis clips,the use of the process,the OTSC release cap can be installed in advance on soft digestive endoscopy,endoscopists will be high-frequency electric knife or snare fixed in the OTSC Release cap on the removal operation,after the completion of the OTSC release cap directly through the release of OTSC anastomosis clip can no longer be as before before the completion of resection and then install the OTSC release cap,to avoid the mirror and the second Into the mirror operation to reduce surgical complications and improve the level of diagnosis and treatment.Implementation method:The multi-functional OTSC captive cap of the OTSC fitting system includes a tubular body with an outer ring and an inner ring adapted to the OTSC fitting of the OTSC fitting system at one end of the body.The inner wall has an OTSC The length of the outer ring is smaller than the length of the inner ring so as to improve the operation field of view,the outer ring and the inner ring form an anastomotic clip set slot,the slot of the anastomotic clip set slot faces towards the end face of the main body,The width of the groove is slightly larger than the thickness of the OTSC fitting,and the end face of the outer ring on the side of the notch is provided with a fixing plate protruding axially,a first threading hole is opened on the fixing plate,a first threading hole corresponding to the inner ring is opened a second threading hole,the front end of the inner wall of the inner ring is provided with a circle of annular convex wall,the annular convex wall is provided with an annular groove and an axial groove for fixing the high-frequency electric knife or snare,the annular groove and the axial groove can also be used for fixing other suitable surgical instruments.The width of the annular groove and the axial groove are both 2mm.The distance between the annular groove and the end face of the inner ring is 1mm.One end of the axial groove is connected with the annular.The groove is communicated with the annular convex wall at the other end formed in the end surface parallel to the slip entrance.The other end of the body is provided with a connecting ring which is matched with the installation end of the flexible digestive endoscope of the OTSC fitting system.The inner diameter of the connecting ring corresponds to the mounting end of the flexible hose.The location of the groove corresponding to the identification of bumps.During installation,the position of the axial groove can be judged by identifying the protruding block,so that the head of the high-frequency electric knife or snare can be easily slid into the axial groove from the sliding inlet and then into the annular groove,the end of the soft end to withstand the end of the soft end of the corresponding position,in order to achieve positioning and fixed function.An annular non-slip pattern is provided on the inner wall of the connecting ring.The non-slip pattern makes the connection between the connecting ring and the soft end of the digestive endoscope firmer to prevent slippage.The distal end of the soft digestive endoscope is slightly inserted into the connecting ring to be fixed.The multifunctional OTSC release cap is made of biodegradable macromolecular material with high temperature and pressure.When in use,the multi-functional OTSC release cap is fixed to the soft end of the soft digestive endoscope through a connecting ring,and a medical nylon rope is knotted at one end of the nylon rope,and the other end passes through the first threading hole and the second threading hole in sequence,and then penetrates through the opening of the connecting ring and then passes along the soft-made digestive endoscope hose to the soft digestive endoscope handle,and with the handle at the auxiliary hand wheel is connected to the end of the nylon rope tied to the outer end of the first threading hole,and then OTSC fitting clip on the outer wall of the inner ring,and the card into the anastomosis folder set slot,nylon rope will follow the OTSC clip into the ankle clip is fit into the slot,in the need to release the OTSC clip,turn the auxiliary hand wheel,thus pulling the nylon rope,nylon rope in constant tension during the process,the OTSC clip will be released after it is pushed out of the slot in the clip. |
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