Bisogni, Damiano

Cianchi, Fabio

DE Masi, Salvatore

Fortuna, Laura

Staderini, Fabio

Talamucci, Luca

English

De Masi, Salvatore

Florence Research

Vol. 79 - No. ?? MiNerVa Surgery 1L E T T E R S  T O  T H E  E D I T O R© 2024 eDiZiONi MiNerVa MeDiCaOnline version at https://www.minervamedica.itMinerva Surgery 2024 Mar 29DOi: 10.23736/S2724-5691.24.10293-6Lights and shadows of three endoscopic techniques as organ-sparing alternatives to surgery for anastomotic leaks after esophago-gastric surgery: results and data analysis of an italian referral single center for gastrointestinal disease treatmentanastomotic leak following upper gastrointestinal (ugi) surgery is one of the most fearsome complica-tions, as it leads to a longer hospitalization and a sig-nificant increase in patients’ morbidity and mortality.1-3 Nowadays, endoscopy has gained more importance in healing of such defects, offering lots of minimally in-vasive repair techniques, such as over-the-scope clips, self-expandable-metal stents (SEMS), endoluminal su-turing (overstitch devices), endoscopic internal drain-age (EID) with double pigtail drains (Advanix®, Bos-ton Scientific, Marlborough, MA, USA), or endoscopic vacuum-assisted (eVT) closure system device (eso-SPONge®, B. Braun Medical Ltd., Sheffield, UK).1, 3, 4Since endoscopic modalities provide lower patients’ mortality and morbidity, thus reducing significantly hospital stay and healthcare costs, they play a pivotal role in management of anastomotic leaks following ugi surgery.3-5The aim of our article is comparing 3 endoscopic tools (eiD, SeMS, eVT) for management of ugi post-surgical defects in 18 patients treated at our hospital in-stitution from April 2018 to November 2022, reporting their impact on surgery-related outcomes. Patients had undergone a surgical operation for esophageal or gastric disease by either a robotic-assisted minimally invasive or a standard laparotomic incision method. Surgical op-erations included in our study are reported in Table I. Collected cases presented a fistula at the level of anas-tomosis, demonstrated by either contrast-medium com-puted tomography or esophagography.When indicated, a percutaneous drainage of large fluid collections within mediastinum or peritoneum Table I.— Study population and surgery-related outcomes.Characteristics SeMS Not SeMS (eiD or VaC)Two devices(SeMS + not SeMS) OverallP valueNumber of leakages, N. 7 4 7 18Type of disease, N. (%)Benign 0 (0) 1 (15.0) 1 (14.3) 2 (11.1) 0.30esophageal malignant 3 (42.9) 3 (75.0) 4 (57.1) 10 (55.6)gastric malignant 4 (57.1) 0 (0) 2 (28.6) 6 (33.3)Surgical access, N. (%)Robotic-assisted minimally invasive6 (85.7) 3 (75.0) 6 (85.7) 15 (83.3) 1.00Laparotomic 1 (14.3) 1 (25.0) 1 (14.3) 3 (16.7)Surgical operation, N. (%)ivor-Lewis esophagectomy 2 (28.6) 2 (50.0) 3 (42.9) 7 (38.9) 0.85Fundoplication procedure for hiatal hernia0 (0) 1 (25.0) 1 (14.2) 2 (11.1)Total gastrectomy 4 (57.1) 1 (25.0) 3 (42.9) 8 (44.4)Partial gastrectomy 1 (14.3) 0 (0) 0 (0) 1 (5.6)Surgical procedural time (minutes), median [iQr]310.0 [302.5- 451.5] 482.5 [395.0-535.0] 455.0 [377.5-522.5] 432.5 [306.3-505.0] 0.69Hospital stay (days), median [iQr] 31.0 [26.0-41.5] 37.5 [29.0-46.0] 57.0 [46.5-62.0] 45.0 [30.25-55.25] 0.02Surgery-related complications, N. (%)respiratory 3 (42.9) 1 (25.0) 3 (42.8) 7 (38.9) 0.92Cardiac 0 (0) 0 (0) 1 (14.3) 1 (5.6)Sepsis 4 (57.1) 2 (50.0) 2 (28.6) 8 (44.4)Others 0 (0) 1 (25.0) 1 (14.3) 2 (11.1)SEMS: self-expandable-metal stents; EID: endoscopic internal drainage; IQR: interquartile range.COPYRIGHT© 2024 EDIZIONI MINERVA MEDICAThis document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover,  overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.2 MiNerVa Surgery Mese 2024 LeTTerS TO THe eDiTOrwas preliminary achieved, as a fundamental prerequi-site for a better outcome of endoscopic procedure. All cases were performed under deep sedation or general anesthesia.Once directly visualized the leak through an ugi endoscopy (using a forward-view gastroscope), a fistu-lography was achieved, in order to assess the features of the defect (including communication with other cavities or organs). A debridement with clearance of necrotic tis-sue as well as lavages of cavity with fluids and hydro-gen peroxide was achieved in all cases, in order to allow a better healing of the wound (reducing infection risks).Selection of endoscopic closure approach was main-ly related to the features of leakage (diameter, depth, necrotic tissue) and patients’ characteristics, as well.2, 3according to current literature, SeMS and eVT were preferentially chosen in case of leaks involving >30% of the circumference or in case of almost com-plete dehiscence, whereas eiD was the approach ofchoice for small-size or initial disruptions.2, 4 regularsessions of endoscopic controls were accomplished,with an interval ranging from 2 days (for eVT) to 10days (for SEMS), making further debridement and al-lowing replacement of the same tool or switching to adifferent device (Figure 1). Technical success was con-sidered as a complete defect closure after endoscopicmanagement, whereas clinical success was defined asa healing of leak and remission of systemic infectionsymptoms (Figure 2).Statistical analysis was performed using r-software version 4.2.2 (The r Foundation, Vienna, austria). Continuous variables were reported as median and in-terquartile range (IQR). Categorical variables were reported as numbers and percentages (%). Association between endoscopic devices and categorical clinical outcomes was evaluated by χ2 test or Fisher exact Tests, when appropriate. Association between endoscopic de-vices and continuous clinical outcomes was evaluated by One-Way ANOVA followed by Tuckey HSD Test, when a significant association emerged. Stratified sur-vival analyses by endoscopic device were performed, as well. Visual inspection of survival curves was carried out with Kaplan-Meier method. Log-rank test was per-formed to evaluate the differences between the curves. In any case, a P value <0.05 was considered significant.Overall, within the 18 patients collected, 16 experi-enced a complete healing of leak, one died during hos-pital stay due to a severe sepsis and one was referred to a further surgical operation (as a complete anastomotic disruption occurred). Patients were equally distributed among the following three cohorts (Table I): SEMS-group, not-SeMS group (experiencing either eiD or EVT) and, finally, a combination of both SEMS and not-SeMS devices (since the endoscopist, during con-trol sessions, considered the switch to a different device as the best choice to yield the healing process). Overall, all the 7 patients treating with two different tolls, expe-rienced a complete repair of the dehiscence and none was re-operated.We noticed that switching from eVT to SeMS pro-vided an optimal healing, since the interim sponge-placement allowed an effective reduction of the cavity in diameter and depth, whereas the subsequent stent-placement sealed the residual wound.According to univariable statistical data analysis, hospital stay was significantly shorter in the SEMS group (P=0.02). in addition, considering hospital stay as the reference continuous variable, Tuckey HSD Test (comparing cohorts between one-another) showed a significant P value whenever the switch of two differ-ent tools versus SeMS were compared. Mean and 95% confidence interval (CI) are reported in Table II.Our data reaffirm Van Boeckel PGA’s paper, in which temporary stent placement for esophageal leaks is described as an effective and safe endoscopic modal-ity for management of anastomotic defects, regardless the features of the stent.1, 2 Concerning the other pa-rameters reported in Table I, no significant difference Figure 1.—Consecutive images temporally showing the progressive healing of a large anastomotic defect, effec-tive treated by EVT. A) Early detection of the leak, with the thoracic drainage appearing through the defect. B) Forcep-assisted positioning of vacuum device at the level of the de-hiscence. C) endoscopic appearance of defect after a few regular sessions of eVT replacement. D) Complete healing of the anastomotic leak at the endoscopic control.Figure 2.—endoscopic appearance of a large anastomotic leak (>30 mm in diameter) resulting after an ivor-Lewis esophagectomy. A) At the first detection, the wall of the cav-ity appears necrotic, with no evidence of granulation tissue. B) a progressive healing of the dehiscence with granulationof the wall is visible after some vacuum-device replace-ments.aDBCa BCOPYRIGHT© 2024 EDIZIONI MINERVA MEDICAThis document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover,  overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.Vol. 79 - No. ?? MiNerVa Surgery 3LeTTerS TO THe eDiTOrFabio STADERINI 2, Salvatore De MaSi 3, Laura FOrTuNa 2, Fabio CIANCHI 21unit of interventional endoscopy, Department of Oncology and Robotic Surgery, Careggi Hospital, Florence, italy; 2unit of gastrointestinal Surgery, Department of Surgery, Careggi Hospital, Florence, italy; 3Clinical Trial Center (CTC), Careggi Hospital, Florence, italy*Corresponding author: Damiano Bisogni, unit of intervention-al Endoscopy, Department of Oncology and Robotic Surgery,Careggi Hospital, Largo Brambilla, Florence, Italy.E-mail: bisognifelice@libero.itReferences1. van Boeckel PG, Sijbring A, Vleggaar FP, Siersema PD.Systematic review: temporary stent placement for benign rup-ture or anastomotic leak of the oesophagus. aliment Pharma-col Ther 2011;33:1292–301. 2. Swinnen J, Eisendrath P, Rigaux J, Kahegeshe L, Lemmersa, Le Moine O, et al. Self-expandable metal stents for thetreatment of benign upper GI leaks and perforations. Gastro-intest endosc 2011;73:890–9.3. Chan SM, Auyeung KK, Lam SF, Chiu PW, Teoh AY. Cur-rent status in endoscopic management of upper gastrointestinal perforations, leaks and fistulas. Dig Endosc 2022;34:43–62. 4. Mandarino FV, Barchi a, Leone L, Fanti L, azzolini F,Viale e, et al. endoscopic vacuum therapy versus self-expand-able metal stent for treatment of anastomotic leaks < 30 mmfollowing oncologic ivor-Lewis esophagectomy: a matchedcase-control study. Surg endosc 2023;37:7039–50.5. do Monte Junior ES, de Moura DT, Ribeiro IB, HathornKE, Farias GF, Turiani CV, et al. endoscopic vacuum therapy versus endoscopic stenting for upper gastrointestinal transmu-ral defects: systematic review and meta-analysis. Dig endosc2021;33:892–902.Conflicts of interestThe authors certify that there is no conflict of interest with any financial organization r egarding t he m aterial d iscussed i n the manuscript.Authors’ contributionsAll authors read and approved the final v ersion o f t he manu-script.HistoryArticle first published online: March 29, 2024. - Manuscript accepted: February 28, 2024. - Manuscript received: Janu-ary 27, 2024.(Cite this article as: Bisogni D, Talamucci L, rossi M, Staderini F, De Masi S, Fortuna L, et al. Lights and shadows of three en-doscopic techniques as organ-sparing alternatives to surgery for anastomotic leaks after esophago-gastric surgery: results and data analysis of an italian referral single center for gastrointes-tinal disease treatment. Minerva Surg 2024 Mar 29. DOi: 10.23736/S2724-5691.24.10293-6)among the three cohorts emerged from the univariable; this datum, still confirming Swinnen J’s paper, may be affected by the small sample size of our single-arm ret-rospective study.2 Log-rank test for follow-up did not reveal any statistically significant difference among the three groups (P=0.66) (Figure 3).Concerning endoscopic EVT, a recently published review proposes a reliable flowchart as management algorithm for leaks.3 In this decision-making flowchart, VAC-therapy can be adopted as interim approach in case of large diameter leaks associated to extraluminal collection, thus confirming our institutional approach, where EVT followed by stent-placement has been ad-opted in case of large defects.3Dealing with eiD, this tool is mainly accomplished in case of small defects, in which this toll may play an important role in reducing extra-luminal collections and stimulating the healing of the fistula thanks to a local traumatism.3, 5in conclusion, considering our experience and lit-erature data overview, we suggest SeMS use in case of large defect without any external fluid collection; EID may be an optimal strategy in case of very small defects, even in association to peri-anastomotic fluid collection. Literature more and more emphasize that eVT (alone or in combination with other devices) could serve as an organ-sparing alternative to surgery for large ugi anas-tomotic defects.2, 3, 5Damiano BiSOgNi 1 *, Luca TaLaMuCCi 1, Michele rOSSi 1, Figure 3.—Kaplan-Meier curve of follow-up time after sur-gery of the three cohorts included in Table I.Log-rank test did not reveal a statistically significant P value among the groups (P=0.66).Table II.— Mean and 95% confidence interval.groups of comparison Mean (95% Ci) adjusted P valueNot SeMS-SeMS 3.1 (-18.9–25.1) 0.93Two devices (SeMS) 21.6 (2.8–40.3) 0.02Two devices (not SeMS) 18.5 (-3.5–40.5) 0.11Survival1.000.750.500.250.00Time (days) 0 20 40 60 80 100 120 140 160 180 200SEMS not SEMS two devicesCOPYRIGHT© 2024 EDIZIONI MINERVA MEDICAThis document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover,  overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.

Lights and shadows of three endoscopic techniques as organ-sparing alternatives to surgery for anastomotic leaks after esophago-gastric surgery: results and data analysis of an Italian referral single center for gastrointestinal disease treatment

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Lights and shadows of three endoscopic techniques as organ-sparing alternatives to surgery for anastomotic leaks after esophago-gastric surgery: results and data analysis of an Italian referral single center for gastrointestinal disease treatment

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