Introduction

The increasing availability of gastrointestinal (GI) interventions has raised the need to treat luminal defects. Endoscopic suturing (ES) is a minimally invasive technique, used for a wide range of indications.

Aims & Methods

This retrospective cohort study aimed evaluate the performance of ES in treating upper GI defects.Data from a tertiary centre were collected for patients undergoing ES to treat upper GI defects. The primary outcome was technical success, defined as the successful sutures’ deployment. Secondary outcomes included immediate clinical success (confirmation of closure at the time of the procedure), recurrence, long-term outcomes and complications. Descriptive statistics and x² test were used to calculate the rates of the outcomes and assess any link between independent variables and results.

Results

Forty-two procedures were performed on 25 patients between 2018 and 2023. The mean age was 55 (±16.2) years and 56% were female. The technical success rate was 88.1% (37/42) and immediate clinical success 91.9% (34/37), with only two (4.8%) adverse events. The overall recurrence rate was 61.8% (21/34), with a long-term clinical success rate of 69.6% (16/23). Technical success was higher in oesophagus (92.3%), and stomach (100%) (p=0.002), and immediate clinical success was more likely in patients with leak (88.9%) or fistula (95.2%) compared to perforation (50%; p=0.005).

Conclusion

ES demonstrated high rates of technical and immediate clinical success for defect closure in the upper GI tract, with low rates of complications. The benefit is most prominently seen among patients with leaks and fistulas in the stomach and oesophagus.

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

Zenker’s diverticulum is associated with a significant burden on quality of life and morbidity, predisposing to dysphagia, regurgitation and aspiration pneumonia. This is often a condition that affects senior patients and access to interventions is limited. Surgery has been the preferred option historically due to a lack of alternative options but remains invasive with major potential complications in an already high-risk patient group. Endoscopic approaches offer a minimally invasive alternative treatment option including rigid and flexible diverticulotomy, and the emerging Zenker per-oral endoscopic myotomy (Z-POEM), albeit no superiority has been demonstrated among these techniques.

Aims & Methods

This systematic review and meta-analysis aimed to summarize the efficacy and safety of these endoscopic techniques.A systematic search in Medline, Cochrane and Scopus databases was performed until November 2023. The primary outcome was technical success, defined as the completion of diverticulotomy/myotomy in one session. Secondary outcomes included clinical success which corresponded to the complete resolution of dysphagia or a post-procedure Dakkak and Bennett score ≤ 1. Moreover, the recurrence rates and the overall adverse events were recorded. Subgroup analyses per outcome were performed to discriminate the results depending on the endoscopic approach (Rigid, flexible diverticulotomy and Z-POEM), whereas the comparative studies were meta-analyzed to compare Z-POEM with alternatives. We used a random effects model and the results were reported as percentages for pooled rates and odds ratios (OR) for comparative data with 95% Confidence Intervals (95%CIs).

Results

From 2004 to 2023 twenty-three studies (1357 patients; 40% female; mean age 43-80) were included in our analysis. The cumulative technical success rate was 97.7% (95%CI: 96.9-98.5) with null heterogeneity (I²=0%), and this outcome was preserved in all subgroups. Considering clinical success, the overall pooled rate was 84.8% (95%CI: 80.8-88.8; I²=79.15%) with Z-POEM yielding higher rate [90.4% (95%CI: 87.8-93.1)] with low heterogeneity (I²=11%), in contrast to the alternatives. 8.6% (95%CI: 6.0-11.3; I²: 63.6%) of cases experienced recurrence, with those post-Z-POEM having the lowest rates [5.7% (95%CI: 2.3-9.1; I²:55.68%)] and post-flexible myotomy the highest ones [12.1% (95%CI: 8.0-16.2; I²=36.09%)]. Finally, complications occurred in 8.7% (95%CI: 6.0-11.4; I2=78.08%) with no changes in subgroup analysis. Five studies (759 patients) provided comparative data for Z-POEM and alternatives. Technical success and recurrence rates were similar between comparators [OR:1.38 (95%CI: 0.59-3.23, p=0.5; I2=0%) and OR:0.69 (95%CI: 0.29-1.51, p=0.39; I²=48.71%), respectively], whereas Z-POEM achieved higher clinical success rates [OR:2.38 (95%CI: 1.54-3.68, p<0.001; I²=0%)]

Conclusion

Endoscopic treatment offers high technical success and symptom resolution in patients with Zenker diverticulum, with relatively low prevalence of adverse events and recurrence. Z-POEM offers higher clinical success rates compared to alternatives with optimal homogeneity.

Introduction

Endoscopic suturing offers a novel minimally invasive technique for deploying full thickness sutures in the gastrointestinal (GI) tract. Indications range from defect closure, post operative leaks, fistula repair, stent fixation and tissue plication for endoscopic sleeve gastroplasty.
Here we report our updated experience of endoscopic suturing for non-bariatric applications in the upper GI tract using the Apollo OverStitch^TM device (Apollo Endosurgery, Austin, Texas). This represents the largest and most diverse case series in a UK cohort of patients.

Aims & Methods

We retrospectively evaluated cases where the Apollo OverStitch^TM device was used at our tertiary upper GI centre. The primary outcomes were immediate technical and clinical success. Technical success was defined as the successful application of sutures. Immediate clinical success was defined according to indication. For defect closure this was evaluated using on the table fluoroscopy/endoscopic visualisation. For stent fixation it was determined by the absence of stent migration at follow up endoscopy.
Secondary outcomes included defect recurrence at follow up investigation. We also evaluated long term clinical success by assessing for resolution of the index clinical issue at the time of latest follow up.

Results

The Apollo OverStitch ^TM device was used 56 times across 35 patients (57% female) between August 2018 and March 2023. The mean age of patients at the time of the index procedure was 58 (+/-17.3 years). Outcomes according to indication are highlighted below (Table 1).
There were five cases (5/56, 8.9%) of technical failure. Three (3/5, 60%) involved iatrogenic perforations at the junction between D1/D2. Three cases (3/37, 8.1%) of immediate clinical failure were reported for the defect closure cohort. In the defect closure cohort there was a recurrence rate of 61.8% (21/34), with a long term clinical success rate of 68.2% (15/22). 14 cases of stent fixation were conducted with a stent migration rate of 35.7% (5/14).
There were two (2/56, 3.6%) cases of bleeding following endoscopic suturing. In both cases bleeding was stemmed endoscopically on the table and prior to the end of the procedure.

Conclusion

Our case series suggests that the Apollo OverStitch^TM device can be used for a diverse range of indications with high rates of immediate technical and clinical success.
We note a high recurrence rate reflecting that many defects require repeat suturing attempts to achieve durable long term closure. We postulate that this may be related tissue epithelisation and/or friability impacting opposition. Furthermore, technical failure occurred most with perforations at the D1/D2 junction. This is likely related to acute angulation which impedes the ability to deploy sutures.
The heterogenous follow up data from this case series impacts the ability to draw firm conclusions regarding long term outcomes. There is an ongoing prospective multicentre registry which will assist in evaluating long term outcomes.

Introduction

The timing of performing upper gastrointestinal endoscopy(EGD) in patients with acute upper GI bleeding remains controversial. Different recommendations exist regarding the ideal time interval between the first clinical presentation of acute upper GI bleeding and EGD, assuming no postponement before patient arrival at the hospital. While it is generally agreed that upper gastrointestinal endoscopy should be performed within 24 hours of the first clinical presentation of acute upper GI bleeding, this recommendation poses a significant challenge for medical staff during weekends and healthcare centres with fewer resources than major hospitals.

Aims & Methods

This study was conducted at the Department of Internal Medicine, Gastroenterology Division, at Aleppo University Hospital between July 2018 and June 2020. The study included patients who were admitted due to acute upper gastrointestinal bleeding. The clinical manifestation of upper gastrointestinal bleeding, its duration, and the interval between the first upper gastrointestinal bleeding and the GI endoscopy were determined. Patients were divided into three groups: Group I underwent urgent endoscopy within less than 24 hours of the first bleeding; Group II underwent endoscopy between 24 and 72 hours from the first bleeding; and Group III underwent endoscopy after 72 hours or more of bleeding.

Results

234 patients were included in the study who were admitted to the hospital and underwent upper gastrointestinal endoscopy. Among them, 58.55% were male and 41.45% were female. The average age of the patients was 57.15.
The most common manifestation of acute upper gastrointestinal bleeding was melena, which was observed in 67.59% of cases, followed by hematemesis (52.99%) and epigastric pain (30.34%). The rate of normal esophageal endoscopy findings was 40% in the first group, 54.84% in the second group, and 64.4% in the third group. Hiatal hernia was observed in 30.77% of patients in the first group, 29.03% in the second group, and 28.89% in the third group. Reflux esophagitis was diagnosed in 10.77% of patients in the first group, 10.48% in the second group, and 20% in the third group. Esophageal varices were diagnosed in 10.77% of patients in the first group, 9.68% in the second group, and 13.33% in the third group.
There was no statistically significant difference in the rates of esophageal endoscopy findings among the study groups, except for the presence of blood-filled esophagus, which was significantly more common in the first group (P < 0.05). The highest rate of normal findings in upper gastrointestinal endoscopy was observed in the third group, which was statistically significant (P < 0.05). Blood in the stomach and erosive gastritis were most frequently observed in the first group, with a statistically significant difference in their favor.
The rates of observing gastric ulcers, gastric erosions, hypertensive gastropathy, gastric varices, gastric tumors, portal hypertensive gastropathy, and diffuse mucosal bleeding were similar among the three study groups without a significant statistical difference . The upper gastrointestinal endoscopy was normal in the duodenum in the highest percentage among patients in group three, with a statistically significant difference (P < 0.05). Blood in the duodenum and duodenal edema were observed with the highest rate in patients of the first group with a statistically significant difference compared to the other two groups (P < 0.05). The evaluation of the duodenum among patients of the first group could not be achieved with a higher rate compared to the other two groups, and the statistical difference was significant.
The percentage of observing esophageal ulcers, esophageal biopsies, adherent thrombus, and vascular distortion were similar among the three groups without a significant statistical difference (P > 0.05). The cause of bleeding was identified with certainty by visualizing the bleeding lesion in 32.31% of patients in the first group, 9.68% of patients in the second group, and 4.44% of patients in the third group. There was a statistically significant difference between the groups in favor of the first group.

Conclusion

Our research revealed no significant variance in endoscopic results in patients who underwent endoscopy at distinct time intervals. However, performing early endoscopy, within 24 hours of the first clinical presentation of acute upper GI bleeding, had a higher incidence of detecting the bleeding lesion and identifying the cause of bleeding in comparison to delayed endoscopy. Our study emphasizes the significance of early endoscopy in patients with acute upper GI bleeding to enhance the possibility of identifying the cause of bleeding and administering timely interventions to minimize complications and mortality.

References

1. Acute upper gastrointestinal bleeding: management. London: National Institute for Health and Clinical Excellence: Guidance; 2012.
2. Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, et al. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med 2010;152(2): 101e13.
3. Gralnek IM, Dumonceau JM, Kuipers EJ, Lanas A, Sanders DS, Kurien M, et al. Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European society of gastrointestinal endoscopy (ESGE) guideline. Endoscopy 2015;47(10):a1e46.
4. Hwang JH, Fisher DA, Ben-Menachem T, Chandrasekhara V, Chathadi K, Decker GA, et al. The role of endoscopy in the management of acute nonvariceal upper GI bleeding. Gastrointest Endosc 2012;75(6):1132e8
5. Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol 2012;107(3):345e60. quiz 61. 6 Stanley AJ, Ashley D, Dalton HR, Mowat C, Gaya DR, Thompson E, et al. Outpatient management of patients with low-risk upper-gastrointestinal hemorrhage: multicenter validation and prospective evaluation. Lancet 2009;373(9657):42e7

Introduction

Complete excision of upper gastrointestinal sub-epithelial lesions (SELs) eliminates diagnostic uncertainty, obviates the need for surveillance and may be necessary for definitive diagnosis and management. Current guidelines lack precision and cohesion, and surgery is associated with significant morbidity. Herein, we describe and report on the outcomes of our SEL algorithm for endoscopic (SAFE) resection.

Aims & Methods

SELs were enrolled prospectively over 115 months until March 2023. All underwent axial (CT) imaging and endoscopic-ultrasonography (EUS) to exclude a large exophytic component or invasion into local structures, and assess for muscularis propria involvement.

Results

106 SELs were resected (mean age 60.6±13.4, 51.9% male; 41 oesophageal, 65 gastric). Oesophageal SELs underwent ESD (n=22) or STER if MP involvement was suspected (n=19). Gastric SELs underwent STER (n=6 at cardia), ESD (n=47) or exposing-EFTR (n=12). Technical success was 97.6% and 92.3% respectively. Five (7.7%) were completed laparoscopically due to deep and broad full-thickness involvement. Five (7.7%) required laparoscopic gastrotomy and surgical retrieval after successful resection and closure due to a large lesion size (mean 47 mm). There was no delayed bleeding, perforation or recurrence at a median of 13 months.

Conclusion

Upper GI SELs are effectively and safely treated by endoscopic resection. The SAFE approach provides a framework that facilitates structured decision-making. Oesophageal SELs suspected to involve the MP should undergo STER. Gastric SELs can be best managed by ESD with a view to proceed to exposing-EFTR. A laparoscopic UGI surgeon should be available in case surgical retrieval of the specimen or laparoscopic completion is required.

Disclosure

Michael J. Bourke: Research Support: Olympus, Cook Medical, Boston Scientific.

Introduction

Gastro-oesophageal reflux disease (GORD) is a common disorder with a prevalence of 10-20%. It occurs from disruption of the gastro-oesophageal flap valve (GFV) and/or a diaphragmatic abnormality causing a hiatus hernia (HH). Transoral incisionless fundoplication (TIF2.0) using the EsophyX device (Endogastric solutions) is an endoscopic treatment for GORD, which recreates the GFV through a partial 270º wrap. Prospective trials show the procedure is safe and effective and is recommended in North American guidelines, yet the experience of TIF is limited in Europe.

Aims & Methods

We conducted a UK-based, retrospective, cohort study to determine the safety and efficacy of TIF2.0. Patients undergoing TIF2.0 by a single operator were identified and analysed between 2019-2023. Patient demographics, reflux assessments (GERD-HRQL, endoscopy, pH testing), and procedural details were recorded. Primary outcomes were technical success and clinical response defined as complete (off regular anti-acid therapy) or partial (reduction from baseline in anti-acid therapy, GERD-HRQL score, and/or physiological parameters) without the need for revision. Secondary outcomes were adverse events and changes in reflux parameters measured by Wilcoxon signed-rank test. A p-value <0.05 was significant.

Results

In total, 81 patients underwent TIF2.0 with 92.0% on oral anti-acid therapy. Median age was 51 (IQR 37-64), 23 (28.4%) were female, and the median ASA grade was 1 (IQR 1-2). A HH was present in 84.6% with an average size of 1.9cm (SD 0.5). The average acid exposure time (AET) was 8.9% (SD 4.1; n=61). The clinical outcomes are summarised in table 1. Technical success was 97.5% (n=79) with an average procedural time of 38.0 minutes (SD 10.3), and 1-day (IQR 1) inpatient stay. The device could not pass the cricopharynx in two patients despite routine balloon dilatation. Over 15.5 months of median follow-up (IQR 7-24), 55% had a complete response, and 71.7% partial response. On logistic regression analysis, no variables were predictive of response. Among those with paired pre-/post-testing, the average GERD-HRQL score reduced significantly (33.9 ±18.6 to 9.1 ±9.2; P<0.001) as well as the average AET (8.9 ±4.1 to 5.1 ±4.0; P=0.005) post-procedure. Procedure or device-related adverse events occurred in 12.2% (n=10), which were all managed conservatively. The single perforation was delayed and managed with intravenous antibiotics and endoscopic vacuum therapy. Seven patients underwent a revisional procedure, including two surgical fundoplications, with 83.3% due to recurrent HH.

Conclusion

TIF2.0 is associated with technical success in 97.5%, clinical response in 71.7%, and significant improvements in GERD-HRQL and AET. Recurrent HH is a frequent cause of failure showing the importance of patient selection and/or need for concomitant HH repair.

Disclosure

RH declares educational grants to support research infrastructure from Cook medical, Odin Vision, Pentax medical, Endogastric Solutions, Apollo Endosurgery, Medtronic, and Aqua Medical