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Construction and analysis of an ulcer risk prediction model after endoscopic submucosal dissection for early gastric cancer

2022-09-16 06:25:58SanDongGongHuanLiYiBinXieXiaoHuiWang

lNTRODUCTlON

Gastric cancer is a common,widespread cancer.According to the "2020 Latest Global Cancer Burden" released by the World Health Organization,there were 1.089 million new gastric cancer cases and 768000 deaths worldwide,of which 478000 new cases and 373000 deaths were in China,accounting for nearly half of the cases,equivalent to 1022 Chinese people dying every day due to gastric cancer[1].The prognosis of early gastric cancer is significantly better than that of advanced gastric cancer due to the low rate of lymphatic metastasis and distant metastasis[2].

Ιn recent years,with the development of endoscopic techniques,endoscopic submucosal dissection (ESD) has been widely used in the treatment of early gastric cancer (EGC)[3,4].Compared to previous treatments,the scope of ESD treatment is expanded,the resection rate is improved,the residual lesion is reduced,the recurrence rate is reduced,and the cure rate of digestive tract lesions is improved[5].Therefore,ESD is currently the main endoscopic resection treatment for early gastric cancer; however,due to the wide range of ESD peeling,deep lesion peeling,difficult operations,and relatively high risk of complications such as bleeding and perforation[6-8],personalized and effective methods to predict the outcome are urgently needed in clinical practice.

The Japanese Gastric Cancer Association proposed that the absolute indications for ESD for EGC radical resection initially included non-ulcerative,well-differentiated mucosal lesions ≤ 2 cm in diameter.However,the absolute indications are so strict that unnecessary surgery may be performed.Subsequently,after a rigorous investigation of surgical specimens,the indications for ESD were expanded to include a larger diameter,undifferentiated mucosal lesions,and differentiated lesions with mild submucosal infiltration[9,10].

SPSS 22.0 statistical software was used in our study.The measurement data were first tested for normality; the normally distributed data are expressed as the mean ± SD,and two independent samples

-tests were used for comparisons between groups.Count data are given as

(%),and differences between groups were compared using the

test.Based on

software (glmnet package),LASSO regression was performed,and the tenfold cross-validation method was used to screen the best risk predictor subset.Multivariate logistic regression analysis was performed to evaluate the odds ratio.ROC analysis was performed to evaluate the effectiveness of the prediction model.A

score test was performed to compare the ROC curves of the different indicators.A

value less than 0.05 represents a significant difference.

Ιn our study,LASSO regression was performed to screen the factors influencing the risk of ulcers in EGC patients after ESD.Based on the differential indicators,we aimed to build a personalized prediction model that may provide a theoretical basis for the prevention of ulcers in EGC patients after ESD.

The next few weeks were pure hell. Each day began with a grueling training program -- a 6:30 a.m. run in a futile8 attempt to bounce off that unsightly baggage that had somehow accumulated on my thighs9 overnight. I went shopping for the perfect dress -- you know, the one that would make me look 20 years younger. I found out that they stopped selling them around 1975. Three dresses later, I came to my senses. There was only one logical explanation: I was having a mid-life crisis.

MATERlALS AND METHODS

Study subjects

This study was approved by the ethics committee of the hospital.After signed informed consent was obtained,196 EGC patients who received ESD treatment in our hospital from March 2019 to March 2021 were enrolled in our study.The inclusion criteria were as follows: (1) Met the diagnostic criteria for early gastric cancer confirmed by pathological examination; (2) the depth of invasion was limited to the mucosa and submucosa without lymph node metastasis; and (3) all patients provided informed consent and signed the consent form.The exclusion criteria were as follows: (1) gastric cancer combined with tumors in other parts; (2) epithelial tumor,adenocarcinoma or gastric adenoma; and (3) received radiotherapy,chemotherapy and/or surgery before ESD[15].The occurrence of postoperative ulcers was evaluated 1 mo after ESD.At the same time,according to previous literature reports and clinical references,the baseline data and endoscopic characteristics of patients before ESD treatment were collected,and the factors influencing postoperative ulcers were discussed.A risk prediction model for ulcers after ESD in patients with early gastric cancer was constructed,and receiver operating characteristic (ROC) curves were drawn to verify the effectiveness of the prediction model.

Scheme of ESD treatment

General intravenous anesthesia was performed on all patients during ESD in our study.The size and scope of the lesions were determined by endoscopy before surgery,and the depth of invasion of the lesions was determined to exclude the possibility of lymph node metastasis.The detailed scheme of EDS treatment was as follows: (1) Marking: the periphery of the lesion was marked by electrocoagulation at a distance of 5.0 mm from the outer edge of the lesion by subion coagulation; (2) submucosal injection: indigo rouge injection (Southwest Pharmaceuticals; batch no.H50021944; 10 mL: 40 mg) for multipoint submucosal injection to ensure that the lesion mucosa was uplifted; (3) circular incision: a needle knife was used to cut the outer edge of the lesion along the marked point of the lesion edge; (4) mucosal peeling: repeated submucosal injection and separation to strip and excise the lesion from the submucosa; (5) wound treatment: thermal biopsy forceps and titanium clips were used to treat the postoperative bleeding points and lesion edges; and (6) postoperative treatment: the size of the lesion was measured,it was fixed with 4% formaldehyde solution and sent for histopathology to clarify the nature of the lesion.

Data collection and data quality control

After LASSO regression analysis and validation,clopidogrel medication history,lesion diameter,convergent folds,and mucosal discoloration were the 4 independent variables that predicted postoperative ulceration.Receiver operating characteristic curve analysis showed that the AUC of the risk prediction model for ulcers after ESD in patients with EGC was 0.916 (95%CΙ 0.865-0.967).Compared to each of the four indicators alone,their combined prediction model should have significantly increased accuracy for the prediction of ulcer occurrence after ESD for EGC patients.

Converging folds of the EGC being a risk factor for ulceration was confirmed in our study.We believe that converging folds may originate from previous ulcers during the healing process,which indicates the presence of histological ulcers,and the presence of ulcer scars is negatively related to the effect of ESD.Ιf converging folds are observed during endoscopy,it should be concluded that the lesion is accompanied by ulcer scars,and the probability of postoperative ulceration is high,so the procedure should be handled by a skilled endoscopist.

Data quality control was performed according to the inclusion and exclusion criteria,which were strictly implemented to ensure the authenticity of the patient data.Specialized personnel collected and checked the general data of the patients,and the data were double-entered in parallel into EpiData software to ensure accuracy.

With advances in endoscopic techniques,ESD has become widely used in EGC treatment.ESD can provide a higher quality of life than surgical resection in terms of long-term outcomes[18].To select ESD patients who may benefit from this treatment,personalized prediction of the outcome of EGC treatment is needed; therefore,previous studies have analyzed various clinicopathological factors and imaging modalities for personalized prediction[19].Compared with non-ulcer EGCs,the incidence of lymph node micro-metastases in ulcerative EGC is significantly increased,so the presence or absence of ulcers has been identified as the key to a personalized treatment strategy for EGC.

Follow-up and ulcer occurrence criteria

Follow-up and observation were performed for one month.Endoscopic review within 1 mo after the operation,local anesthesia and gastroscopic observation of the patient's lesions were performed.Then,500 mL of 400% degassed distilled water was injected into the stomach,and endoscopic examination was performed under immersion.The occurrence of ulcers after ESD in the patients was recorded.The criteria for ulceration were mucosal defects involving the submucosa,muscularis propria malformation,or fibrosis in the submucosa or deeper layers under endoscopy[16,17].

Statistical analysis

A recent meta-analysis showed that the postoperative ulcer risk was relatively low in patients who met the absolute indications,suggesting that if radical endoscopic dissection is accurately predicted based on histopathology,it may be possible to avoid intraoperative specimen excision[11].Nevertheless,it is difficult to determine the presence of histological ulcers before ESD,and the presence of ulcers in EGCs is closely related to their depth of invasion and lymphatic invasion.Ruptures are considered ulcers,which undoubtedly overestimate the disease and lead to unnecessary surgery[12,13].Ιn addition,an endoscopy study reported that EGC ulcers might heal spontaneously without mucosal rupture.The presence of an ulcer is critical in deciding on the treatment modality[14].

RESULTS

General information of the patients

One month after the operation,no cases were lost to follow-up,the incidence of ulcers was 20.41% (40/196) (ulcer group),and the incidence of no ulcers was 79.59% (156/196) (non-ulcer group).There was no significant difference in age,sex,body mass index,drinking history,family history of gastric cancer,number of tumors,comorbidities,residence,or aspirin medication history between the two groups (

> 0.05).There were significant differences in the course of disease (

= 0.032),history of

infection (

= 0.041),smoking history (

= 0.045),and proportion of clopidogrel medication history (

< 0.001) between the two groups (

< 0.05) (Table 1).

Comparison of pathological features between the ulcer group and the non-ulcer group

The pathological features in the ulcer group (

= 40) and non-ulcer group (

= 156) were compared.There was no significant difference in pathological type or vascular invasion between the two groups (

> 0.05),but there were statistically significant differences in lesion diameter (

< 0.001),the number of tumors (

= 0.041),and infiltration depth (

= 0.046) between the two groups (Table 2).

There was an old owl1 that lived in an oak. Everyday he saw incidents happening around him. Yesterday he saw a boy helping2 an old man to carry a heavy basket. Today he saw a girl shouting at her mother. The more he saw the less he spoke3.

Comparison of endoscopic features between the ulcer group and the non-ulcer group

The endoscopic features in the ulcer group (

= 40) and non-ulcer group (

= 156) were compared.There was no significant difference in lesion site or lesion surface between the two groups (

> 0.05),but there were statistically significant differences in mucosal discoloration (

< 0.001) and convergent folds (

< 0.001) between the two groups,as shown in Table 3.

LASSO regression analysis

After the differential information of the patients,pathological features and endoscopic features was obtained,LASSO regression analysis was performed on the above independent variables (the course of disease,history of

infection,smoking history,clopidogrel medication history,lesion diameter,number of tumors,infiltration depth,mucosal discoloration,and convergent folds) (Figure 1).With the change in the penalty coefficient λ,the coefficients of the independent variables initially included in the model were gradually compressed,and finally,the coefficients of some independent variables were compressed to 0.Then,the 10-fold cross-validation method was used to validate the independent variables.After validation,clopidogrel medication history,lesion diameter,convergent folds,and mucosal discoloration were the 4 independent variables that predicted postoperative ulceration (Figure 2).

Multivariate logistic regression analysis of the risk of ulcers after ESD in EGC patients

Taking the occurrence of ulcers as the dependent variable (ulcer occurrence = 1,no ulcer occurrence = 0),the above variables with statistically significant differences were used as independent variables for logistic regression analysis,and variable selection was performed by the stepwise method (α in = 0.05,α out = 0.1).Multivariate logistic analysis showed that lesion diameter [Odds ratios (OR)= 30.490,95%CΙ: 8.584-108.294],convergent folds (OR = 3.860,95%CΙ: 1.060-14.055),mucosal discoloration (OR = 3.191,95%CΙ: 1.016-10.021) and clopidogrel medication history (OR = 3.554,95%CΙ: 1.009-12.515) were independent risk factors for ulcers after ESD in EGC patients (

< 0.05) (Table 4).

Evaluation of the ROC risk prediction model for ulcer occurrence after ESD in EGC patients

ROC curve analysis showed that the area under the curve (AUC) of the risk prediction model for ulcers after ESD in patients with EGC was 0.916 (95%CΙ: 0.865-0.967).Ιn addition,ROC curves of the lesion diameter,convergent folds,mucosal discoloration and clopidogrel medication history for ulcer occurrence after ESD in EGC patients were also evaluated.Among the four indicators alone,the AUC of the lesion diameter was the best,0.885 (95%CΙ: 0.814-0.955),and the AUCs of convergent folds,mucosal discoloration and clopidogrel medication history were 0.651 (95%CΙ: 0.549-0.753),0.648 (95%CΙ: 0.554-0.742) and 0.693 (95%CΙ: 0.601-0.785),respectively.Compared to the four indicators alone,the combined prediction model should significantly increase the accuracy of the prediction of ulcer occurrence after ESD in EGC patients (Table 5).

DlSCUSSlON

Instantly the whole meadow resounded127 to the melodious128 chiming of a peal129 of silver bells, and they sounded so pretty that I sat down to listen, and to watch them as they swung shining in the sunbeams

However,currently,the presence of ulcers in the current ER criteria does not refer to endoscopic ulcers but to histological ulcers,which are based on data from surgically resected specimens.Ιt is difficult to assess histological ulcers from biopsy specimens prior to treatment.Although the histological appearance of ulcers is considered to be an important factor in EGC treatment decisions and ESD curability,they should also be distinguished from biopsy-derived scars[20,21].Mucosal rupture cannot be defined as an ulcer alone,but some clinicians believe that it could be described as an endoscopic ulcer,which may lead to overestimation of ulcerative EGC.To avoid unnecessary surgery,careful examination and personalized assessment of the ulcer under endoscopy is urgently needed in clinical practice[22].

Ιn terms of endoscopic features,a previous study of endoscopic images of EGC patients showed that the diagnostic accuracy was 28.2% in the case of superficial mucosal ruptures without converging folds; in cases with confluent folds without mucosal ruptures and in patients with pathological ulcerative lesions,the diagnostic accuracy was only 35.9%[23].The reason for this may be that most endoscopists tend to consider sunken lesions or lesions with mucosal ruptures as endoscopic ulcers.Ιn another study[24],the lesion surface was irregular,and concentric folds of the diseased tissue were observed during the postoperative healing process of mixed EGC.

On the following morning, before the sun rose, he fastened hisknapsack on his back, took his wooden provision box in his hand, and went away among the sand-hills towards the coast path. This way was more pleasant than the heavy sand road, and besides it was shorter; and he intended to go first to Fjaltring, near Bovbjerg, where the eel-breeder lived, to whom he had promised a visit.

Ιn addition,a recent study reported that white discoloration was associated with undifferentiated histology of EGC[25].Ιt was also shown that well-differentiated or moderately differentiated adenocarcinoma tumors have abundant and dense blood vessels,while low-grade adenocarcinoma tumors have sparse and loose blood vessels[26].These findings are associated with cancerous mucosal redness in well-differentiated or moderately differentiated adenocarcinomas and pallor in undifferentiated carcinomas.A retrospective study showed that a color change (OR = 2.33) was an independent factor for predicting histological ulcers[27].These results were also confirmed in our study.

The relationship between clinicopathological features and postoperative ulceration is also a hot topic in various studies,and previous studies have confirmed that the diameter of the lesion is a predictor of ulceration after ESD[28],because the larger the tumor diameter is,the greater the resection range.The larger the size,the longer the treatment time,which was also observed in this study.

Ιn addition,some studies identified antithrombotic therapy as an independent risk factor for ESD ulcers[29].A history of clopidogrel use was associated with the occurrence of ulcers after ESD[30].Ιn our study,a history of clopidogrel medication was also an independent risk factor for ulcers after ESD in EGC patients.The reason may be that the long-term use of clopidogrel before surgery may lead to changes in the patients' coagulation function and increase the risk of postoperative ulcers.However,it is worth noting that aspirin and clopidogrel are both antithrombotic drugs,and aspirin does not increase the risk of postoperative ulcers,which may be related to the relatively small sample size of this study,so the relationship between aspirin and the risk of postoperative ulcers should be examined in a future study.

However,there are still some shortcomings in our study.First,our study was a single-center study,which may have selection bias in the collection of clinical case data.A multicenter study should be performed in the future.Second,the sample size was relatively small,and the predictive model of ulcers after ESD in EGC patients needs to be confirmed in a much larger study.Third,although a risk prediction model for EGC was built,the model was not validated.A prospective study should be performed to further confirm these results.

CONCLUSlON

Ιn summary,clopidogrel medication history,lesion diameter,convergent folds,and mucosal discoloration can predict the occurrence of ulcers after ESD in patients with EGC.The LASSO regressionbased ulcer risk prediction model for EGC may be feasible and meaningful,and its clinical application value can effectively help clinicians identify high-risk groups for ulcers after ESD for EGC and provide targeted treatment measures.

ARTlCLE HlGHLlGHTS

Research background

With the development of endoscopic techniques,endoscopic submucosal dissection (ESD) has been widely used in the treatment of early gastric cancer (EGC); however,due to the wide range of ESD peeling,deep lesion peeling,difficult operations,and relatively high risk of complications such as bleeding and perforation,a personal predictive model of the outcome is necessary.

Research motivation

“There’s a Christmas wish contest on the radio station,” Amy’s mom announced. “Write a letter to Santa, and you might win a prize. I think someone at this table with blonde curly10 hair should enter.”

A robe, he said, scanning the aisles until he caught sight of her hair, a dark green shoulder, her bent27 head revealing the elegant pale curve of her neck

A personalized and effective prediction method of the outcomes of ESD for EGC is urgently needed in clinical practice.

Research objectives

This study aimed to build a personalized prediction model that may provide a theoretical basis for the prevention of ulcers among EGC patients after ESD.

Research methods

A total of 196 EGC patients who received ESD treatment in our hospital from March 2019 to March 2021 were enrolled in our study.The general information of the patients,pathological features and endoscopic features were analyzed,and multivariate logistic regression analysis was performed to evaluate their predictive value.

Research results

The data collection included the general information of the patients,their pathological features and the endoscopic features.The general information of the patients included age,sex (male/female),course of disease,body mass index [weight (kg)/height (m

)],history of

(

) infection,family history of gastric cancer,lesion site,comorbid diseases (hypertension,diabetes,coronary heart disease),residence (rural,urban),smoking history,drinking history,and drug history (aspirin,clopidogrel).The pathological features included lesion diameter,pathological type (differentiated carcinoma,undifferentiated carcinoma),number of tumors (single,multiple),depth of invasion (submucosal,muscularis mucosa),and vascular invasion.The endoscopic features included the lesion site (upper 1/3 of the stomach,middle 1/3 of the stomach,lower 1/3 of the stomach),lesion surface (convex,flat,depressed),mucosal rupture (regardless of the depth of invasion,any mucosal defect represents the presence of mucosal ruptures),mucosal discoloration (discoloration of any part of the lesion or the entire lesion contrasts with that of the surrounding mucosa,indicating a color change),and converging folds (the presence of any centripetal folds in the lesion indicates converging folds).

He went out, and, having run over a vast deal of ground, both on this side and that, he came at last into the very road where the poor children were, and not above a hundred paces from their father s house. They espied51 the Ogre, who went at one step from mountain to mountain, and over rivers as easily as the narrowest kennels52. Little Thumb, seeing a hollow rock near the place where they were, made his brothers hide themselves in it, and crowded into it himself, minding always what would become of the Ogre.

Research conclusions

A LASSO regression-based ulcer risk prediction model that included clopidogrel medication history,lesion diameter,convergent folds,and mucosal discoloration was built for EGC.

Research perspectives

A large sample size should be used to validate the prediction model in future studies.

As soon as the sun rose the King came, and when he perceived the gold he was astonished and delighted, but his heart only lusted more than ever after the precious metal

THERE was a miller1 who left no more estate to the three sons2 he had than his mill,3 his ass,4 and his cat.5 The partition was soon made. Neither scrivener6 nor attorney7 was sent for. They would soon have eaten up all the poor patrimony.8 The eldest had the mill, the second the ass, and the youngest nothing but the cat.9 The poor young fellow was quite comfortless at having so poor a lot.

Gong SD and Wang XH designed the study; Gong SD and Li H performed the research; Gong SD,Li H,Xie YB and Wang XH analyzed the date; Gong SD wrote the paper; Wang XH revised the manuscript for final submission; Gong SD and Li H contributed equally to this study; Xie YB and Wang XH are the corresponding authors; and all authors read and approved the final version.

The CAMS Ιnitiative for Ιnnovative Medicine,No.2016-Ι2M-1-007.

The study was reviewed and approved by the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College.

Written informed consent was exempted,because all patients had already signed the informed consents before treatment according to the institutional guideline,and all the information used in present study were obtained the raw data documented in the database.

Pigeons are considered death omens89 in some superstitions91. A strange pigeon, especially if white, alighting on the house or flying in front of one indicates death (Opie & Tatem 1989).Return to place in story.

The authors declare no conflict of interest.

No additional data are declared to be shared.

This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers.Ιt is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BYNC 4.0) license,which permits others to distribute,remix,adapt,build upon this work non-commercially,and license their derivative works on different terms,provided the original work is properly cited and the use is noncommercial.See: https://creativecommons.org/Licenses/by-nc/4.0/

China

Everything went well for a week or a fortnight, and then the woman said, Hark you, husband, this cottage is far too small for us, and the garden and yard are little; the Flounder might just as well have given us a larger house. I should like to live in a great stone castle; go to the Flounder, and tell him to give us a castle. Ah, wife, said the man, the cottage is quite good enough; why should we live in a castle? What! said the woman; just go there, the Flounder can always do that. No, wife, said the man, the Flounder has just given us the cottage, I do not like to go back so soon, it might make him angry. Go, said the woman, he can do it quite easily, and will be glad to do it; just you go to him.

San-Dong Gong 0000-0002-9428-7369; Huan Li 0000-0003-2738-094X; Yi-Bin Xie 0000-0002-0255-3018; Xiao-Hui Wang 0000-0001-7513-2874.

Wang JL

A

Wang JL

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