Application Of Near Infrared Fluorescence Imaging In Deep Infiltrating Endometriosis

Objective:To explore the safety and feasibility of near infrared fluorescence imaging(NIRF)compared with traditional laparoscopic white light(WL)visualization in the diagnosis and treatment of deep infiltrating endometriosis(DIE),further analyze the significance of NIRF-ICG in the detection and surgical resection of DIE,and provide clinical data for the objective evaluation of NIRF-ICG in DIE.We will promote the transformation of traditional medicine into precision medicine.Methods:A single-center,prospective clinical trial was conducted.Patients meeting the exclusion criteria in Maternal and Child Health Hospital of Gansu Province from December 2021 to December 2022 were selected,and the control group and experimental group were set up.In the control group,only intraoperative and postoperative complications,changes in hemoglobin before and after surgery,length of stay,adverse reactions and other safety indicators were recorded.Chi-square test was used to compare the safety and feasibility of NIRF-ICG in DIE patients.In addition to the safety indexes recorded in the experimental group,all suspected DIE lesions were identified and excised by using fluorescence and white light mode interconversion,and pathological examination was performed.Chi-square test was used to compare the detection rate of DIE lesions between WL and NIRF mode in the experimental group.Meanwhile,Chi-square test and Cohen’s kappa consistency test were further applied to analyze the significance of the two modes in the detection of DIE lesions alone or in combination.Results:1.A total of 33 patients in the experimental group(WL+NIRF)meeting the criteria were included in this study,and the age distribution range of patients was 25-46 years old(median age was 32 years old).A total of 30 patients were included in the control group(WL),ranging in age from 22 to 46 years(median age was 33 years old).The surgical indications of the two groups were: infertility 5 cases(15.15%)VS 1 case(3.3%),endometriosis 25 cases(75.7%)VS 25 cases(83.3%),adenomyosis or adenomyoma 3 cases(9.1%)VS 4 cases(13.3%).In the experimental group,ICG was injected intravenously for single or multiple times,and the interval was >10min,intraoperative ICG development time 37-59 s,average development time 45s;Development exposure time ranged from 260 to 340 s,with an average development exposure time of 295 s.2.The intraoperative blood loss in the experimental group ranged from 2-300 ml,with only 1 case exceeding 100 ml,while the intraoperative blood loss in the control group ranged from 2-50 ml,with an average of 14 ml.The experimental group had a minimum postoperative hemoglobin reduction of 25g/L,and the control group had a minimum postoperative hemoglobin reduction of 23g/L.No adverse reactions and postoperative complications such as drug allergy occurred in the experimental group during and after operation,and 1 case of intestinal tube injury occurred in the control group.The length of hospitalization in the experimental group ranged from 3 to 13 days,and the mean and median were 6 days.In the control group,the length of hospitalization ranged from 3 to 11 days,and the mean and median length were also 6 days.There were no significant differences in intraoperative blood loss,preoperative and postoperative hemoglobin changes,length of stay and postoperative complications between the two groups(P>0.05).3.A total of 170 suspected endometriosis lesions(WL+NIRF)were removed in the experimental group.148 lesions(87.1%)were detected by WL mode,of which 128(86.5%)were pathologically positive.142 suspected endometriosis lesions were detected by NIRF mode(120 were seen in WL mode),of which 124(87.3%)were pathologically positive,while the remaining 22(12.9%)lesions were pathologically positive only by NIRF mode.In the pelvic distribution of DIE lesions,there was no statistically significant difference in suspected endometriosis lesions detected by NIRF mode versus WL mode,with p values as follows:bladder area(0.296)VS sacral ligament/posterior fornix area(0.373)VS fossa/ureter running area(0.435)VS rectal area(0.870).4.In the experimental group,the sensitivity(Se)was 88.3%(128/145)VS85.5%(124/145)under WL mode and NIRF mode,respectively.The specificity(Sp)was88%(148/168)VS 88.8%(142/160).Positive predictive values(PPV)were 86.5%(128/148)VS 87.3%(124/142),respectively.Negative predictive values(NPV)were 89.7%(148/165)VS 87.1%(142/163).There was no significant difference in SE,SP,PPV,and NPV between WL mode and NIRF mode,P>0.05.The sensitivity(Se)of DIE lesions under WL and WL combined NIRF mode visualization was 88.3%(128/145)VS 100%(145/145),respectively.The specificity(Sp)was 65.5%(38/58)VS 56.9%(33/58).Positive predictive values(PPV)were 86.5%(128/148)VS 85.3%(145/170),respectively.Negative predictive values(NPV)were 69.1%(38/55)VS 100%(33/33).In general,the combined visual detection of the two modes was more advantageous than the single WL mode in the detection of DIE lesions in Se and NPV,with statistical difference,P<0.001.Secondly,it was found that the consistency between lesions detected by WL mode and WL combined with NIRF mode was moderate(Kappa values were 0.546 and 0.653),and the combination of these two methods could achieve imaging complementarities.5.In subgroup analysis,there was a statistically significant difference between WL mode and NIRF mode in patients with rASRM Stage Ⅲ with suspicious lesions in DIE(P=0.047).For other rASRM stages and VAS scores,there were no significant differences between the two groups(P>0.05).Conclusion:The combination of NIRF-ICG imaging technology in the treatment of endometriosis by laparoscopy is safe in clinical application,with good fluorescence-guided surgical resection,high detection rate of DIE lesions,and reduced surgical complications.NIRF-ICG alone has a certain reference value in the detection of DIE lesions.Compared with WL mode,the detection rate of lesions in the ovarian fossa/ureter and rectum was higher,but there was no statistical significance.However,NIRF-ICG allows the surgeon to use reverse imaging to remove hidden lesions and avoid missing incision,which has implications for reducing recurrence.The use of NIRF-ICG to detect endometriosis in 2D laparoscopic surgery is feasible and should not be considered as a stand-alone technique,but as an effective complement to intraoperative visualization techniques.