Introduction

Although Gastric Peroral Endoscopic Myotomy (G-POEM) has shown substantial efficacy in patients with medically refractory gastroparesis (GP), comprehensive long-term data on its effectiveness are lacking.

Aims & Methods

We conducted a systematic review and meta-analysis including observational studies assessing long-term outcomes after G-POEM in patients with refractory GP. Our primary outcome was the pooled rate of clinical success1-year after G-POEM. Secondary outcomes included clinical success rates beyond 1 year, and the rate of adverse events (AEs).

Results

Fifteen studies, comprising 986 patients with refractory GP undergoing G-POEM, were eligible. The pooled 1 year-success rate was 0.722 (95% CI: 0.56, 0.86, I²=94.92%). In the subgroup analysis, which included only studies enrolling patients with 4-hour Postprandial Gastric Residual (PGR) ≥ 10%, the clinical success rate was 0.610 (95% CI: 0.526, 0.709, I²=46.66%). The pooled success rates at 2 and 3 years calculated on followed-up patients were 0.861 (95% CI: 0.72, 0.96, I²=85.11%) and 0.838 (95% CI: 0.56, 0.99, I²=91.90%), respectively. In the subgroup analysis including studies that did not exclude non-responding patients from follow-up, the 2-year pooled success rate was 0.838 (95% CI: 0.60, 0.98, I²=89.49%). The pooled rate of AEs was 0.092 (95% CI: 0.06, 0.13, I²=81.35%), specifically 0.078 mild and 0.014 moderate AEs, according to the American Society for Gastrointestinal Endoscopy classification.

Conclusion

G-POEM is a safe procedure with 1-year success in more than 2/3 of treated cases and substantial benefit also at 2 and 3-years follow-ups. Future studies with strict patient selection and uniform outcome definitions are warranted.

Introduction

Propofol administration managed directly by the gastroenterologist is a sedation regimen, which is broadly spreading, in clinical practice in Endoscopy Units (EU) all over the world [1]. This is primarily due to a very high patient and endoscopist satisfaction. Moreover, fears associated with propofol use by non-anesthesia providers are based on sound theoretical principles. Non-anesthesiologist-administered-propofol (NAAPS) managed by the gastroenterologist is an issue still controversial for many anesthesiologist societies.

Aims & Methods

This study aims to analyze safety outcomes between NAAPS sedation and anesthesiologist-assisted deep sedation during endoscopic procedures for low-risk patients. We retrospectively assessed data from low anesthesiologist risk-patients (American Society of Anesthesiologists I-II), undergone esophagogastroduodenoscopies (EGDs) and colonoscopies under NAAPS sedation, and assisted anesthesiologist-deep sedation, between May 2019 and October 2021, in a tertiary center. Primary outcome was to compare sedation related-adverse events rates between NAAPS and deep sedation. Propensity score matching analysis was performed using sex, age, Body Mass Index (BMI), smoking, comorbidities and time examination in order to standardize baseline variables.

Results

Overall, in colonoscopies subset, 2491 patients were managed under NAAPS and 257 patients under deep sedation, whereas in EGDs subset, 2439 patients were managed under NAAPS and 282 patients under deep sedation. In unmatched analysis, no difference was shown in terms of adverse events rates between NAAPS and deep sedation, both in EGDs and colonoscopies subsets (1.8% vs 3.5%; p=0.202 and 1 vs 0,4%, p=0.815, respectively). After matching, EGDs subset analysis comprised 282 procedures in NAAPS group versus 188 in deep sedation group, whereas colonoscopies subset included 256 patients in NAAPS group and 174 in deep sedation group. Matched analysis revealed non-different adverse events rate between moderate and deep sedation groups (colonoscopies 3.5% vs 0.6%, p=0.249 and EGD 0.4% vs 1%, p=0.452, respectively).

Conclusion

NAAPS during endoscopy represents a safe sedation modality, comparable with safety outcomes of anesthesiologist-assisted deep sedation. Cost-efficacy analyses are needed, in order to highlight economic advantages of non-anesthesiologist management of propofol during endoscopy.

References

[1] Gouda B, Gouda G, Borle A, Singh A, Sinha A, Singh PM. Safety of non-anesthesia provider administered propofol sedation in non-advanced gastrointestinal endoscopic procedures: A meta-analysis. Saudi J Gastroenterol. 2017;23(3):133-143. doi:10.4103/sjg.SJG_501_16

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.

Introduction

In recent years, propofol has become the sedative of choice for gastrointestinal endoscopy. Despite large cohort studies demonstrating its safety and effectiveness, the adoption of Non-Anesthesiologist Administration of Propofol (NAAP) in clinical practice still faces numerous challenges, both in Europe and globally. Consequently, propofol-based sedation remains largely in the hands of anesthesia professionals.

Aims & Methods

This study was conducted in two phases. Initially, a preliminary analysis was carried out to compare adverse event (AE) rates between NAAP and Anesthesiologist Administration of Propofol (AAP) at a tertiary academic center (San Raffaele Hospital, Milan, Italy). In the second phase, potential cost savings from implementing NAAP over AAP at the hospital, local, and national levels were examined.
Propensity score matching (PSM), based on age, sex, body mass index (BMI), and ASA Physical Status Classification System score, was used to compare the two cohorts. A 3-year budget impact model (BIM) was implemented based on the annual volume of outpatient endoscopy procedures performed at San Raffaele Hospital and estimates of the Italian adult population by Italian National Institute of Statistics (ISTAT).

Results

From May 2019 to October 2021, 2,721 patients who underwent esophagogastroduodenoscopy (EGD) (2,439 NAAP and 282 AAP) and 2,748 who underwent colonoscopy (2,491 NAAP and 257 AAP) in outpatient setting were enrolled. Only diagnostic procedures were included. After PSM, the EGD cohort included 282 patients under NAAP and 188 under AAP, while the colonoscopy cohort consisted of 256 patients under NAAP and 174 under AAP. No significant differences in AE rates were observed between the groups in both the EGD (overall: NAAP 1.1% vs AAP 0.8%, p=0.815; after PSM: NAAP 0.4% vs. AAP 1.0%, p=0.452) and colonoscopy cohorts (overall: NAAP 1.7% vs AAP 3.5%, p=0.202; after PSM: NAAP 3.5% vs. AAP 0.6%, p=0.249). All AEs were managed without leading to major or long-term sequelae.
According to the BIM, a complete implementation of NAAP instead of AAP for patients classified as ASA 1 and 2 would lead to financial savings of €851,649 at our hospital, €8.3 million for the Local Health Authority of Milan, €19.8 million for the Lombardy region, and €124.7 million for the Italian National Health System over the triennium 2023-2025.

Conclusion

NAAP is a safe sedation modality for outpatient gastrointestinal endoscopy, with AE rates comparable to those of AAP. Its widespread implementation, at the expense of AAP, could result in savings exceeding €120 million for the Italian National Health System over the triennium 2023-2025.

References

NAAP is a safe sedation modality with AE rates comparable to AAP. The widespread implementation of NAAP, rather than reliance on anesthesiologist-led propofol sedation, could result in savings exceeding €120 million for the Italian National Health System over the triennium 2023-2025.

Introduction

Scarred colo-rectal lesions still represent an endoscopic challenge due to technical feasibility and histologic radicality. The optimal endoscopic technique of choice remains controversial.
Endoscopic submucosal dissection (ESD) has been proposed as an option since it allows “en-bloc” resection and low rates of recurrence [1],[2]. Nevertheless, it represents a time-consuming procedure, burdened by complications in non-experts’ hands. Hybrid ESD (H-ESD), has been suggested as rescue therapy in cases where complete ESD is not feasible [3].

Aims & Methods

We retrospectively analyzed a prospectively collected cohort of 180 patients who underwent ESD for scarred colorectal lesions at San Raffaele Scientific Institute in Milan and Arcispedale Santa Maria Nuova, Reggio Emilia, Italy, between January 2009 and October 2022. Procedures were performed by expert endoscopists, who had completed more than 60 colo-rectal ESD. Primary outcome was to assess technical success, defined as the completion of an “en-bloc” ESD. Technical failure was defined as the need of conversion to H-ESD to complete the procedure. Secondary outcomes included: curative resection (cR), defined as submucosal invasion < 1,000-micron, complete resection (CR), defined as en-bloc resection with free histologic margins and recurrence rate at follow-up. Lesions characteristics, technical data of procedures, adverse events rate were also collected. Predictive factors of technical success were assessed through univariate analysis and multivariate logistic regression.

Results

Mean age was 68.42±11.4 years (range 38-89), with a 56/44 female to male ratio. Most of the lesions were in the rectum (50.6%), followed by left colon (13.9%), transversum (9.4%) and right colon (26.1%). Grade of fibrosis was mostly severe (F3 56.7%; F2 24.4%; F1 18.9%), due to previous treatment attempts (70.6%) or biopsy sampling (29.4%). Mean diameter of lesions was 35.06±20.04 cm² with a mean procedural time 99.9±60.4 min and a mean dissection speed of 9.13±8.13 mm²/min. Technical success with completion of the ESD was 62.2% (112/180) with an overall en-bloc resection rate of 96.4%, while conversion to H-ESD was needed in 37.8% (68/112) of cases with en-bloc resection rate of 32.3%, due to severe fibrosis (38/68), difficult access (17/68), perforation (4/68), hemodynamic instability (2/68). Overall, CR rate was 60.6%, while cR was obtained in 92.3% of cases. No difference between ESD and H-ESD were found in term of neither CR and cR (p=0.725 and p=0.787 respectively). Nine patients (4.8%) were referred for additional surgery due to non-curative histology after endoscopic treatment (adenocarcinomas 11.7% and neuroendocrine carcinomas 1.7%). In total, 24 adverse events (13.3%) occurred, the majority in completed ESD group (20/24 cases), mostly perforations (7%) which were all managed endoscopically. Recurrence occurred in 13 patients (7%) during a mean follow-up period of 374 days (range 55-1808). At the multivariate analysis fibrosis due to previous treatment (OR 3.08 [95 % CI 1.25-7.58], p=0.0243), high grade of fibrosis (OR 2.30 [95 % CI 1.35-3.93], p=0.0021) and right colon location (OR 1.96 [95 % CI 1.48-2.62], p=0.000003) resulted as predictive factors of technical failure.

Conclusion

ESD is a feasible, safe and effective treatment for colorectal-scarred lesion, when performed by expert endoscopists, showing high rates of “en-bloc” resection and assuring high histologic radicality and low rate of recurrence. H-ESD is a viable rescue treatment when the completion of ESD is not feasible.

References

1. Azzolini F, Camellini L, Sassatelli R, et al. Endoscopic submucosal dissection of scar-embedded rectal polyps: a prospective study (Esd in scar-embedded rectal polyps). Clin Res Hepatol Gastroenterol. 2011;35(8-9):572-579. doi:10.1016/j.clinre.2011.04.013
2. Hurlstone DP, Shorthouse AJ, Brown SR, Tiffin N, Cross SS. Salvage endoscopic submucosal dissection for residual or local recurrent intraepithelial neoplasia in the colorectum: a prospective analysis. Colorectal Dis. 2008;10(9):891-897. doi:10.1111/j.1463-1318.2008.01510.x
3. Chedgy FJ, Bhattacharyya R, Kandiah K, Longcroft-Wheaton G, Bhandari P. Knife-assisted snare resection: a novel technique for resection of scarred polyps in the colon. Endoscopy. 2016;48(3):277-280. doi:10.1055/s-0035-1569647

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.

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

Gastric peroral endoscopic myotomy (G-POEM) has proven to be an effective technique for treating refractory gastroparesis^1,2. However, data on the long-term outcomes of the technique remain limited. We present findings from a multicenter study with over one year of follow-up.

Aims & Methods

In this retrospective study, patients undergoing G-POEM for refractory gastroparesis at two Italian centers from March 2019 to October 2024 were included. Primary endpoints were clinical success rates at 1 and 2 years. Secondary endpoints included factors associated with long-term clinical success (CS), changes in Gastric Emptying Study (GES) results, and Body Mass Index (BMI). CS was defined as a ≥1-point improvement in the Gastroparesis Cardinal Symptom Index (GCSI) and a 25% reduction in two symptom subscales.

Results

A total of 56 patients underwent G-POEM (median age 61 years [IQR 25: 45.8 - IQR 75: 71.5], 57.1% female, and 60.8% with idiopathic gastroparesis).
Technical success was achieved in 54 out of 56 cases (96.4%). Only two adverse events were recorded (3.5%, both grade 1 according to the AGREE classification). The median length of myotomy was 3.00 cm (IQR 25: 3.00 - IQR 75: 5.00). Single-layer myotomy was performed in 12 patients (21.4%), while 42 patients (78.6%) underwent full-thickness myotomy.
CS rates were 70.0% (35/50 patients) at 3 months, 66.7% (31/45 patients) at 6 months, 64.9% (24/37 patients) at 12 months, and 57.1% (16/28) at 24 months, with a significant change over time (𝑄=25.36, p<0.001). Among patients with CS at 12 months, 4 experienced symptoms relapse at 24 months, while 1 patient achieved success at 24 months despite not having CS at 12 months. There were no differences in success rates based on the etiology of gastroparesis (Table 1)
In multivariate regression logistic, age (OR = 1.27, p=0.02) and baseline GCSI (OR = 1.45, p=0.03) were significant predictors of CS at 1 year.
Among patients with CS at two years, there was no significant difference between pre-procedure and post-procedure BMI (median follow-up time 1091 days)(22.6 vs 22.0, p=0.40) or between pre- and post-procedure GES t ½ (median follow-up time 901 days)(174 vs 101 min, p=0.078).

Table 1: Clinical success subgroup analysis

Conclusion

The efficacy of G-POEM decreases over time, reaching approximately 60% at two years. Long-term clinical success does not correlate with changes in BMI or GES parameters. Further studies are needed to better understand factors influencing long-term outcomes of G-POEM and to optimize patient selection.

References

1. Mandarino FV, Vespa E, Barchi A, et al. Precision Endoscopy in Peroral Myotomies for Motility Disorders of the Upper Gastrointestinal Tract: Current Insights and Prospective Avenues-A Comprehensive Review. Life (Basel). 2023;13(11):2143. Published 2023 Oct 31. doi:10.3390/life13112143
2. Mandarino FV, Testoni SGG, Barchi A, et al. Gastric emptying study before gastric peroral endoscopic myotomy (G-POEM): can intragastric meal distribution be a predictor of success?. Gut. 2023;72(5):1019-1020. doi:10.1136/gutjnl-2022-327701