Introduction

Anastomotic leak remains one of the most critical complication after Ivor-Lewis esophagectomy [1][2]. While intra-cavitary approach for Endoscopic Vacuum Therapy (EVT) has been proved effective for the treatment of large dehiscences [3], no data exist comparing intraluminal EVT and Self-expanding Metal Stent (SEMS) in the management of non-large (<3 cm) anastomotic dehiscences.

Aims & Methods

In this matched-at-enrollment case-control study (1:1), we included patients who received EVT and SEMS for non-large (<3 cm) anastomotic dehiscences after oncologic Ivor-Lewis esophagectomy between May 2014 and July 2022. The primary outcome was successful closure of the leak. Exclusion criteria were: anastomotic dehiscences > 3 cm, early (≤ 2 days) and late (4 weeks) diagnosis after surgery, severe gastric conduit necrosis, sepsis/septic shock at diagnosis.

Results

Overall, 22 patients treated with EVT and 22 treated with SEMS, were matched by age (p=0.070), sex (p=0.262), BMI (0,247), American Society of Anesthesiologists (ASA) score (p=0.386), neoadiuvant radio/chemotherapy (p=0.15), dehiscence diagnosis modality (0.761), defect type (leak or fistula) (p=1.00), PCR values (p=0.103) surgical re-intervention before endoscopic treatment (p=0.472) and leak size (p=0.931). EVT and SEMS revealed no difference in leak resolution (90.9% vs 72.7%, respectively; p=0.21), whereas EVT group was associated with higher number of procedures (4.41 vs 2.18, p= 0.05, respectively). Concerning adverse events (AE’s), both EVT and SEMS showed no statistical difference in AE’s rates (p=0.61). Overall outcomes of endoscopic procedures are shown in Table 1.

Conclusion

EVT and SEMS has shown similar efficacy outcomes in the treatment of non-large (< 3 cm) anastomotic defects after Ivor-Lewis esophagectomy. Prospective comparison data are needed to validated these findings.

References

1. Seesing MFJ, Gisbertz SS, Goense L, van Hillegersberg R, Kroon HM, Lagarde SM, Ruurda JP, Slaman AE, van Berge Henegouwen MI, Wijnhoven BPL (2017) A Propensity Score Matched Analysis of Open Versus Minimally Invasive Transthoracic Esophagectomy in the Netherlands. Ann Surg 266: 839–846
2. Kassis ES, Kosinski AS, Ross P Jr, Koppes KE, Donahue JM, Daniel VC (2013) Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg 96: 1919–1926
3. Zhang CC, Liesenfeld L, Klotz R, Koschny R, Rupp C, Schmidt T, Diener MK, Müller-Stich BP, Hackert T, Sauer P, Büchler MW, Schaible A (2021) Feasibility, effectiveness, and safety of endoscopic vacuum therapy for intrathoracic anastomotic leakage following transthoracic esophageal resection. BMC Gastroenterol 21:72

Disclosure

Prof. Silvio Danese has served as a speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma and Vifor. The other authors declare no conflict of interests. Dr Francesco Vito Mandarino, Dr Alberto Barchi, Dr Lorenzo Leone, Dr Lorella Fanti, Dr Francesco Azzolini, Dr Edi Viale, Dr Dario Esposito, Dr Noemi Salmeri, Dr Francesco Puccetti, Dr Lavinia Barbieri, Dr Andrea Cossu, Dr Elio Treppiedi, Dr Ugo Elmore and Prof Riccardo Rosati have no conflict of interest to disclose.

Introduction

Endoscopic Vacuum Therapy (EVT) and Fully Covered Metal Stents (FC-SEMS) are standard treatments for anastomotic leaks (AL) following upper gastrointestinal (UGI) surgery^1-3. Recently, a new hybrid device combining an FC-SEMS with a polyurethane EVT sponge (VACStent) has been introduced, showing promising results⁴. However, there is not comparative data between VACStent and traditional endoscopic methods for ALs.

Aims & Methods

In this retrospective study, all patients with AL after UGI oncologic surgery who underwent EVT or VACStent at a tertiary academic center from March 2015 to September 2024 were included. The two endoscopic techniques were compared. The primary outcome was clinical success (CS), with secondary outcomes including number of devices used, treatment duration, and adverse events (AEs).

Results

Over 114 months, 103 patients [92 EVT, 11 VACStent] were enrolled. Of these, 74.8% had AL following Ivor-Lewis esophagectomy. The two cohorts did not differ significantly in terms of comorbidities, neoadjuvant treatment, leak number/median size, or rates of redo-surgery before endoscopic management. Both EVT and VACStent were used as first-line treatments in a similar rate of patients (79.3% vs. 90.9%, p=0.36).
The EVT group had a higher CS rate than the VACStent group, though this difference was not statistically significant (72.8% vs. 54.5%, p=0.21). Compared to the EVT group, the VACStent group required significantly fewer endoscopic sessions (1±0.7 vs. 3±2.5, p<0.001) and had a shorter mean treatment duration (12.1±11.2 vs. 14.1±12.9 days, p=0.62). Additionally, a significantly lower proportion of patients in the VACStent group required admission to the intensive care unit (ICU) (27.3% vs. 84.4%, p<0.001). In the EVT group, three adverse events were recorded (one bleeding episode and two sponge dislodgments), while no AEs were reported in the VACStent group (p=0.54) (Table 1).

Table 1 EVT vs ​VACStent: Outcomes

Conclusion

In this retrospective study, EVT and VACStent showed comparable success in treating post-UGI surgery leaks. VACStent was associated with a reduced need for ICU admission and fewer endoscopic sessions. Larger comparative data are warranted to define the role of VACStent in the treatment of leaks after UGI surgery.

References

1. Mandarino FV, Barchi A, Leone L, et al. Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study. Surg Endosc. 2023;37(9):7039-7050. doi:10.1007/s00464-023-10213-8
2. Mandarino FV, Barchi A, D'Amico F, et al. Endoscopic Vacuum Therapy (EVT) versus Self-Expandable Metal Stent (SEMS) for Anastomotic Leaks after Upper Gastrointestinal Surgery: Systematic Review and Meta-Analysis. Life (Basel). 2023;13(2):287. Published 2023 Jan 19. doi:10.3390/life13020287
3. Mandarino FV, Barchi A, Fanti L, et al. Endoscopic vacuum therapy for post-esophagectomy anastomotic dehiscence as rescue treatment: a single center case series. Esophagus. 2022;19(3):417-425. doi:10.1007/s10388-022-00912-x
4. Dell'Anna G, Fanti L, Fanizza J, et al. VAC-Stent in the Treatment of Post-Esophagectomy Anastomotic Leaks: A New "Kid on the Block" Who Marries the Best of Old Techniques-A Review. J Clin Med. 2024;13(13):3805. Published 2024 Jun 28. doi:10.3390/jcm13133805

Introduction

The Updated Sydney System recommends reporting the severity of both glandular atrophy (GA) and intestinal metaplasia (IM) as two independent parameters. However, the OLGA system assesses both GA and IM together as part of the same entity which should be reported as an average severity. The OLGIM system is based on the IM severity recommended by the updated Sydney system. Thus, the final OLGIM score can be estimated by any clinician. Currently, no system addresses the severity of both GA and IM as they are reported following the updated Sydney recommendation.

Aims & Methods

This study aimed to assess the utility of a new system, OLGIMA (Operative Link on Gastric IM and GA assessment), as a tool to identify patients at higher risk for GC in daily practice.
Consecutive diagnostic UGI endoscopies performed for any indications in patients older than 18 years old were recorded prospectively in 21 Spanish hospitals between April 2021 and July 2023. Protocolized gastric biopsies were taken according to the Updated Sydney consensus. We excluded patients with dysplasia, any malignancy, suspicion of autoimmune chronic atrophic gastritis, and lack of histological data. The severity of both GA and IM was assessed in the antrum (including incisura) and corpus following the updated Sydney system. After that, we considered the most advanced severity (none:0; mild:1; moderate:2; marked:3) provided for any of them in each of the two topographical areas. Then, the OLGIMA staging was done according to the same methodology used by the OLGA and OLGIM systems.

Results

A total of 998 patients were included. The median age was 57 (IQR 46 - 67), and 64% were women. Hp infection was identified in 334 (35%) patients (19% active infection and 16% eradicated). GA was identified in 192 (19.2%) patients which was limited to the antrum in 113 (11.3%) cases and extensive in 79 (7.9%). IM was identified in 159 (15.9%) patients which was limited to the antrum in 114 (11.4%) cases and extensive in 45 (4.5%). According to IM severity, 27 (2.7%) patients were OLGIM III/IV. According to GA severity, 22 (2.2%) patients were significantly extensive. The OLGIM system would have missed 12 (1.2%) patients with GA at higher risk. Considering both criteria, we would have detected 39 (3.9%) patients at higher risk in total (17 OLGIM III-IV, 12 extensive significative GA, and 10 both OLGIM III-IV and extensive significative GA). The new OLGIMA system categorized all 39 (3.9%) patients, OLGIM III-IV and significantly extensive GA, in the high-risk group (OLGIMA III/IV).

Conclusion

The new OLGIMA system (based on the severity of IM and GA recommended by the updated Sydney system) was able to detect patients at higher risk including all cases of OLGIM III/IV and also with advanced GA. The OLGIMA staging is much simpler and it can be estimated by any clinician regardless of whether the biopsy from incisura was taken.

References

Rugge M, Meggio A, Pennelli G et al. Gastritis staging in clinical practice: the OLGA staging system. Gut. 2007;56:631-6
Capelle LG, de Vries AC, Haringsma J et al. The staging of gastritis with the OLGA system by using intestinal metaplasia as an accurate alternative for atrophic gastritis. Gastrointest Endosc. 2010;71:1150-8
Pimentel-Nunes P, Libânio D, Marcos-Pinto R et al. Management of epithelial precancerous conditions and lesions in the stomach (MAPS II): European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter and Microbiota Study Group (EHMSG), European Society of Pathology (ESP), and Sociedade Portuguesa de Endoscopia Digestiva (SPED) guideline update 2019. Endoscopy. 2019;51:365-388.

Introduction

Collagenous colitis (CC) is a form of microscopic colitis (MC), the others being lymphocytic colitis (LC), incomplete CC and incomplete LC (1). It is an inflammatory disease of the large bowel that causes chronic watery diarrhoea, abdominal pain, faecal incontinence, nightly defecation, and weight loss, resulting in significantly impaired quality of life (2). Incidence of MC has increased significantly during the past decades in some countries and the main reason for this increase is thought to be an enhanced disease recognition (3). The diagnosis of MC is challenging as it can only be diagnosed upon histological examination of colonic biopsies taken from normal or near normal appearing mucosa (1). Histological interpretation of biopsies involves subjective evaluation leading to inter-rater variability discrepancies in diagnosis and treatment plan. Deep learning-based assistance system can objectivise diagnostic key feature selection leading to minimisation of inter-rater variability and improvement of diagnostic accuracy.

Aims & Methods

The aim of this pilot study was to develop an algorithm for robust segmentation of light microscopy images of histological specimen slides (tissue slides) emphasizing key diagnostic features of CC.
Histological specimens were fixed with formalin, embedded in paraffin, cut into 3 µm sections, and stained with haematoxylin and eosin (H&E) for histological examination. Images were taken using OLYMPUS IX71 light microscope (x20 magnification) equipped with Q IMAGING EXI aqua camera at (1392 x 1040 pix.) resolution and 24-bit pixel encoding. Registered image pixel values were normalized in RGB colour space by histogram alignment using empty tissue-less areas using an algorithm described previously (4). Superpixel technique using Simple Linear Iterative Clustering algorithm (5) was used for initial segmentation of the images. All 1000 superpixels defined in each image were annotated by the expert, indicating ones containing thickened subepithelial collagen layer as the sought class among the others containing the rest of the tissue indicated as normal class. The feed – forward neural network (implemented in MatLab environment) was trained to classify superpixels using their normalized histogram bin-counts of the pixel values as a feature. Due to significant inequality in the data set, where the number of sought class superpixels was significantly smaller than the number of the remaining ones, the training set was formed by equalising it to the lowest class case’s value (18761). Only randomly selected cases of the bigger class were included in the training set.

Results

The proposed algorithm was tested on images from 5 treatment-naive patients with newly diagnosed CC. Patients' histological specimens were rated by an expert pathologist and 50 images were chosen (with changes characteristic of CC and without). The classification training process with extracted data set took 0.13 seconds on personal computer with an AMD Ryzen Threadripper 3970X 32-Core, 3.70 GHz processor and 128GB of RAM memory, epochs for training was set to 30 (after tests the model was not improving after 30 epochs) and data shuffling was set to every-epoch. The algorithm showed 0.807 accuracy, 0.801 sensitivity and 0.813 specificity.

Conclusion

The shown ability of deep learning algorithm to classify histology image segments can assist the diagnostic process of CC emphasizing thickened subepithelial collagen layer – the essential diagnostic feature.

References

1. Miehlke S, Guagnozzi D, Zabana Y, Tontini GE, Fiehn AMK, Wildt S, et al. European guidelines on microscopic colitis: United European Gastroenterology (UEG) and European Microscopic Colitis Group (EMCG) statements and recommendations. United European Gastroenterol J. 2020;
2. Verhaegh BPM, Münch A, Guagnozzi D, Wildt S, Cebula W, Diac AR, et al. Course of Disease in Patients with Microscopic Colitis: A European Prospective Incident Cohort Study. J Crohns Colitis. 2021;15(7):1174–83.
3. Weimers P, Ankersen DV, Lophaven S, Bonderup OK, Münch A, Løkkegaard ECL, et al. Incidence and Prevalence of Microscopic Colitis between 2001 and 2016: A Danish Nationwide Cohort Study. J Crohns Colitis. 2021;14(12):1717–23.
4. Petrolis R., Čižas P., Borutaitė V., Kriščiukaitis A. Method of fluorescence imaging for evaluation of membrane potential in cultured neurons using transmembrane voltage sensitive dye. Biomedical engineering 2011: Proceedings of International Conference. 14:16-19, 2011.

5. Achanta R, Shaji A, Smith K, Lucchi A, Fua P, Susstrunk S. SLIC Superpixels Compared to State-of-the-art Superpixel Methods. IEEE Transactions on Pattern Analysis and Machine Intelligence, Volume 34, Issue 11, pp. 2274-2282, May 2012

Introduction

Managing leaks and defects of the upper gastrointestinal (UGI) tract remains challenging. Endoscopic Vacuum Therapy (EVT) is a promising option^1-3; However, data on its efficacy in large cohorts remain limited.

Aims & Methods

This retrospective study with prospectively collected data enrolled all consecutive patients with UGI defects treated by EVT at a single academic center (San Raffaele Hospital, Milan, Italy) from March 2015 to September 2024. The primary outcome was clinical success (CS). Secondary outcomes included median treatment duration/devices, technical success (TS) and adverse events (AEs). Clinical success (CS) was defined as complete endoscopic and/or radiologic defect healing, with the patient remaining asymptomatic. Adverse events (AEs) were classified according to the AGREE classification.

Results

Over a period of 114 months, 96 patients [72.9% male, median age 67 years (IQR 57-75), 49% ASA 3] were included. Among them, 66 patients (68.7%) had anastomotic leaks after Ivor-Lewis esophagectomy, with 57% undergoing neoadjuvant chemotherapy. The median leak size was 7 mm (IQR 4-10), with a median circumferential involvement of 20% (IQR 10-40). A fistula involving the airways was present in 28.1% of cases. EVT was the first-line treatment in 78.1% of patients, with a median time from surgery to EVT of 7 days (IQR 4-9).
The overall clinical success (CS) rate was 72.9% (70/96 patients). Of the remaining patients, 20 underwent redo-surgery. Technical success for all procedures was 100% (302/302 procedures). The median treatment duration was 11 days (IQR 5-18), with a median of 3 EVT sessions (IQR 2-4). Three adverse events (AEs) (3/302, 1%) were recorded, including one bleeding episode and two sponge dislodgments, all managed endoscopically (AGREE IIIa). During a median follow-up of 62 days (IQR 33-155), two cases (2.1%) of esophageal strictures were reported (Table 1)
In the subgroup analysis, the intraluminal (IL) group (n=70) had a lower mean number of EVT sessions (3±2 vs. 5±3, p<0.001) and a shorter mean treatment duration (11±10 vs. 21±16 days, p<0.001) compared to the intracavitary (IC) group (n=26).

Table 1: Outcomes

Conclusion

EVT is a safe and effective treatment for UGI defects. The IL approach was associated with shorter treatment duration and fewer sessions compared to the IC approach. Further controlled studies are needed to optimize EVT application and outcomes.

References

1. Mandarino FV, Barchi A, Leone L, et al. Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study. Surg Endosc. 2023;37(9):7039-7050. doi:10.1007/s00464-023-10213-8
2. Mandarino FV, Barchi A, D'Amico F, et al. Endoscopic Vacuum Therapy (EVT) versus Self-Expandable Metal Stent (SEMS) for Anastomotic Leaks after Upper Gastrointestinal Surgery: Systematic Review and Meta-Analysis. Life (Basel). 2023;13(2):287. Published 2023 Jan 19. doi:10.3390/life13020287
3. Mandarino FV, Barchi A, Fanti L, et al. Endoscopic vacuum therapy for post-esophagectomy anastomotic dehiscence as rescue treatment: a single center case series. Esophagus. 2022;19(3):417-425. doi:10.1007/s10388-022-00912-x

Introduction

Per-oral endoscopic myotomy (POEM) has revolutionised achalasia treatment, nevertheless there is still a lack of technical standardization. No clear definition of “long”, “standard” or “short” POEM exists to date. With the exception of type III achalasia, there is evidence that myotomy limited to the lower esophageal sphincter (<6 cm) may be highly effective, time-saving and associated with less post-postoperative gastroesophageal reflux, yet it is common practice to use long myotomy in these patients.

Aims & Methods

We conducted a systematic review with meta-analysis to define current myotomy length standards during POEM. A literature search was performed on MEDLINE-Pubmed, Embase, Scopus, and Cochrane Library (from inception to December 2022). We included prospective, retrospective clinical studies and randomized controlled trials reporting technical details of POEM, in which no definite or comparative myotomy length was intentionally adopted thus representing a “standard” myotomy for the operator. The primary outcome was the pooled mean total myotomy length. Secondary outcomes included clinical success and reflux symptoms. Main exclusion criteria were: patient age < 18 years; studies providing achalasia diagnosis without high-resolution manometry, studies including patients with non-achalasia esophageal motility disorders, studies comparing different myotomy lengths or adopting pre-specified myotomy lengths, studies including type III achalasia patients only. Sub-group analyses were performed to explore heterogeneity across studies and to assess the impact of different subtypes, geography and time trends on the primary outcome.

Results

From initial 7,172 records, after exclusion criteria were applied, a total of 25 articles were included. Of those, 6 provided results on the primary outcome in separate subgroups and were therefore included as separate studies. Overall, 31 studies with a total 3023 patients were evaluated. The pooled mean of total myotomy length was 10.39 cm (95% CI 10.06-10.71; I² 99.3%). The pooled mean of esophageal and gastric myotomy length, provided by 17 studies, was 7.11 cm (95% CI 6.51-7.71; I² 99.8%) and 2.81 cm (95% CI 2.41-3-22; I² 99.8%) respectively. At the subgroup analysis for achalasia subtypes, pooled mean length in non-spastic achalasia (type I and II) was 10.17 cm (95% CI 9.91-10.43; I² 94.2%), while in type III attested at 14.02 cm (95% CI 10.59-17.44; I² 98.9%). Pooled mean myotomy length for studies conducted between 2014-2018 was 10.56 cm (95% CI 9.51-11.61; I² 99.0%) while studies between 2019-2022 showed a mean length of 10.3 cm (95% CI 9.99-10.61; I² 99.6%). No geographical difference was observed: in eastern countries mean length was 10.2 cm (95% CI 9.12-10.92; I² 98.9%), while in western countries was 10.95 cm (95% CI 9.83-12.07; I² 99.5%). At a median follow-up of 29 months, the pooled clinical success rate was 91% (95% CI 88.9%-93.2%; I² 67.2%), while the pooled rate of post-POEM clinical reflux was 26% (95% CI 21.0%-31.3%; I² 89.5%).

Conclusion

Our meta-analysis found that the pooled mean myotomy length during a "standard” POEM is 10.4 cm, remaining over 10 cm in non-spastic (type I and II) achalasia. The high heterogeneity across studies confirms that POEM technique needs further standardization. We found no time trend towards adopting short POEM, despite recent evidence supporting efficacy and safety of this approach.