Clinical Case Summary

Endoscopic vacuum therapy(EVT) is an effective alternative in the treatment of transmural defects of the gastrointestinal tract. We present 5 clinical cases of extended use of EVT.
Case1:26-year-old man with mediastinal seminoma undergoing chemotherapy. Presented Fournier’s gangrene associated with abscess and fistulization to the rectum. Treated with diverting colostomy, vacuum therapy in the perianal wound, and EVT in the rectal abscess(7 changes, 3 weeks), with clinical, radiological, and endoscopic improvement.
Case2:43-year-old woman. Endoscopic submucosal dissection of a middle rectum lesion complicated by late perforation and peri-rectal abscess. EVT was placed without colonic diversion(4 changes, 2 weeks)with therapeutic success.
Case3:62-year-old man. Dehiscence of esophagojejunal anastomosis with peri-anastomotic leakage and communication to the peritoneal cavity. EVT was placed(3 changes, 2 weeks), and later discontinued due to local active bleeding (possible contact with large vessels, not confirmed radiologically), and complete granulation of the leakage site. Final therapeutic success was achieved.
Case4:54-year-old man. Dehiscence of esophagogastric anastomosis(>75% circumference) with peri-anastomotic abscesses and tracheoesophageal fistula(TEF). EVT was placed (8 changes, 4 weeks). Despite resolution of the dehiscence, EVT was maintained due to persistence of TEF and associated with argon-plasma application, closure of TEF was achieved. After removal, an anastomotic stricture refractory to dilation appeared, and a lumen-apposing metal stent was placed with reappearance of TEF. Once more, closure of TEF was managed with EVT (single change) and argon-plasma.
Case5:73-year-old man. Dehiscence of esophagogastric anastomosis(~50%) with communication to the pleural cavity.EVT was placed(4 changes, 3 weeks)with therapeutic success.
These cases illustrate the effectiveness of EVT in managing difficult situations.

Disclosure

Nothing to disclosure.

Clinical Case Summary

A 43-year-old woman with a rectal 90mm granular laterally spreading tumor involving 50% of the circumference (distal limit at 12cm from the anal verge) underwent endoscopic submucosal dissection (ESD). Due to submucosal fibrosis, deep laceration of the muscularis propria occurred at the end of the procedure and two through-the-scope (TTS) clips were applied and broad-spectrum antibiotics were administered. In the following day, the patient developed sepsis and an emergency CT scan revealed free air in mesorectum and densification of the perirectal/presacral adipose tissues with contrast extravasation. Proctosigmoidoscopy showed an orifice of approximately 12mm, near the previous TTS clips, that communicated with a 15mm abscessed cavity, compatible with delayed perforation (Figure 1). Endoluminal vacuum therapy (EVT) was initiated with a 2cm Endo-SPONGE^® (B.Braun Medical B.V., Melsungen, Germany), partially intraluminal, without immediate complications (Figure 2). The patient was kept under parenteral nutritional, antibiotics and twice weekly EVT sponge replacement, with a total of four substitutions. The evolution was favorable with sepsis resolution, decrease of the cavity length and complete tissue granulation (Figure 3). The patient was discharged after 16 days and remained asymptomatic with complete closure at the 1.5 months follow up (Figure 4).

References

(Figure 1). (Figure 2). (Figure 3) (Figure 4).

Introduction

Oesophageal leaks and fistulae are a major complication of upper gastrointestinal surgery leading to high rates of postoperative morbidity and mortality. Self-expanding metal stents (SEMS) are the endoscopic mainstay of treatment. Recently, endoscopic vacuum therapy (EVT) as emerged as a promising alternative. The present study intends to evaluate the success rate and safety of EVT versus SEMS in upper gastrointestinal tract surgical leaks/fistulae in a referral centre.

Aims & Methods

We included all patients undergoing EVT in 2022-2023 (n=5) versus all patients submitted to SEMS from 2014 to 2022 (n=39) due to upper gastrointestinal tract surgical leak/fistulae.

Results

There were no statistically significant differences regarding distribution by gender, age, benign vs malignant disease, time from complication diagnosis to endoscopic treatment, time from surgery to endoscopic treatment and leak size (p>0.05).
The success rate, defined as complete closure of the surgical leak/fistulae, was reached in all patients submitted to EVT and in 56.4% of patients with SEMS (p=0.14). Two patients undergoing EVT were previously submitted to unsuccessful SEMS treatment. The median number of endoscopic treatment sessions were significantly superior for EVT [4 (IQR:3) vs 2 (IQR:1); p<0.01].
Technique related complications, readmission and mortality rates were superior in SEMS vs EVT (76.9% vs 0%; 51.3% vs 20%; 35.9% vs 0%, respectively), although these differences were only statistically significant for complication rate (p<0.01). None of the deaths were related to stent placement.

Conclusion

Although with a higher number of treatment sessions, our experience showed that EVT is a safe and effective alternative to endoscopic stenting, with higher success rate (100% vs 56.4%) and lower complication, readmission, and mortality rates. Our data shows that EVT has the potential to become the new gold standard in the endoscopic treatment of oesophageal leaks and fistulae.

Introduction

Ulceration at the gastrojejunostomy is a late complication following gastric bypass surgery, usually responsive to high dose PPI. However, in refractory cases, patients may require surgical treatment. Recently, a new technique of endoscopic jejunal flap over-suturing has been reported with exceptional success rates. We aimed to evaluate the implementation of this approach in our practice.

Aims & Methods

Consecutive patients with symptomatic marginal ulcers, who failed to response to a two-month course of high dose PPI were included. Patients were treated with endoscopic suturing of a jejunal flap over the ulcer. In case of a narrow anastomosis, a self-expandable metallic stent (SEMS) was used alone or in combination with suturing. The stent was removed after 2 months. Endoscopy was repeated 8 weeks after the procedure. Technical success was defined as a fully covered marginal ulcer. Clinical success was defined as an ulcer heal on repeat endoscopy, while persistent ulcer, perforation or need for surgical repair was considered as failure.

Results

Ten patients were included, seven after Roux-en-Y gastric bypass and after 3 single anastomosis gastric bypass. All patients were negative for Helicobacter Pylori, deny alcohol abuse or NSAIDS use, 2 patients were active smokers at the time of diagnosis. All patients were on chronic PPI at the time of diagnosis, and the average therapy duration was 27 months. Jejunal over-suturing was performed in 9 patients of them 3 in combination with a SEMS, and 1 patient was treated only with a SEMS. Overall technical success rate was 100%, and a clinical success rate was 50% with 4 patients going through surgery thereafter. No adverse events occurred during the procedure or follow up period.

Conclusion

To date, marginal ulcers remain a dreaded late adverse event necessitating prolonged PPI use, repeat endoscopies and even revisional surgery. Endoscopic treatment to promote healing of refractory marginal ulcers appears safe. Technical success was achieved in all patients while clinical success only in half. However, since the only alternative treatment is surgery the endoscopic approach should still be considered. The lower than expected clinical success might be related to a more PPI resistant population compared with previous published series. Further research is needed to determine the appropriate therapeutic algorithm.

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

Esophageal or gastric perforation is associated with systemic inflammatory response syndrome (SIRS), which can lead to multi-organ dysfunction and mortality in up to 50% of cases. Endoscopic vacuum therapy involves the use of a catheter with a sponge attached to its distal end, connected to a machine that applies negative pressure, allowing for continuous drainage of the perforation site and potentially promoting healing of the transmural defect. Previous series have reported promising results, indicating the potential effectiveness of this therapy in managing esophageal perforations. To evaluate the efficacy of endoscopic vacuum treatment in patients with primary or secondary gastroesophageal perforations.

Aims & Methods

Single-center retrospective cohort study on patients treated for gastroesophageal perforation between March 2019 and September 2022. The inclusion criteria for the study were patients with gastroesophageal perforation resulting from spontaneous rupture or iatrogenic damage (post-surgical or post-endoscopic treatment). The primary outcomes of the study were the success rate of endoscopic therapy, the length of hospital stay, and the specific survival at 30 and 90 days. The success rate of endoscopic therapy was assessed by considering the treatment successful if it led to the resolution of the fistula following vacuum endoscopic therapy. Secondary endpoints included the need for intensive care unit (ICU) stay between the start of vacuum endoscopic therapy and the patient's discharge.

Results

27 patients, with a mean age of 69.8 years (95% CI 65.4-74.3), including 9 (33.3%) women, underwent endoscopic treatment with vacuum therapy for esophageal perforation. The causes of perforation were as follows: 6 (22.2%) cases were primary (Boerhaave syndrome), 15 (55.5%) cases were post-surgical (post-surgical anastomosis), and 6 (22.2%) cases were post-endoscopic treatment (endoscopic dilatation). Among the patients, 13 (48.1%) had previously undergone surgery for cancer, with 69.2% of them receiving intrathoracic stomach interposition reconstruction and the remaining patients undergoing reconstruction according to Roux-en-Y procedure. The treatment was successful in 21 (77.7%) patients, with a 14 days (9.0-24.4, 95% CI) median duration of treatment, and 4 (3-7, 95% CI) median number of endoscopic devices used per patient. One patient (3.7%) died within 30 days, and another one (3.7%) within 90 days. A total of 10 (38.4%) patients required an ICU stay, and there were no readmissions within 30 days. No procedure-related complication was reported.

Conclusion

In the current pilot study, the findings support the feasibility and safety of endoscopic vacuum therapy as a treatment modality for both primary and secondary gastro-esophageal perforations.

References

• Kuehn F, Schiffmann L, Rau BM, Klar E. Surgical endoscopic vacuum therapy for anastomotic leakage and perforation of the upper gastrointestinal tract. J Gastrointest Surg 2012
• Pattynama LMD, Eshuis WJ, van Berge Henegouwen MI, Bergman J, Pouw RE. Vacuum-stent: A combination of endoscopic vacuum therapy and an intraluminal stent for treatment of esophageal transmural defects. Front Surg 2023
• Luttikhold J, Pattynama LMD, Seewald S, et al. Endoscopic vacuum therapy for esophageal perforation: a multicenter retrospective cohort study. Endoscopy 2023

Disclosure

Dr Valente and Dr Arnelo are consultant to Boston Scientific. Dr Arnelo is Consultant to Ambu

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