Introduction

The Luso-Cor^​ esophageal stent was developed for management of fistulas and dehiscences after bariatric and gastric oncologic surgery.

Aims & Methods

The study aims to evaluate the efficacy and safety of Luso-Corin managing fistulas and strictures after gastric surgery. This is a retrospective and multicentric study involving 35 consecutive patients with adverse events after gastric surgery who were managed with the Luso-Cor^Ò esophageal stent, between July 2016 and February 2023. The adverse events were: fistulas after sleeve gastrectomy(n=28), anastomotic dehiscence(n=4) and gastric tube stricture after bariatric surgery(n=3). The technical success was defined as the effective exclusion of the fistula and the clinical success as fistula closure or effective stricture dilation after stent removal. Endoscopic reinterventions and adverse events were analyzed with descriptive statistics.

Results

Median age was 50(20-84) years, 69%(n=24) were women. Median fistula orifice size was 5.5(2–20)mm. The median duration of stent implantation was 6(1-18) weeks. An endoscopic reintervention was required in 31.43%(n=11) patients due to the following reasons: Inadequate coaptation of the proximal flare to esophageal wall(n=6), migration(n=3), stricture(n=1), stent fracture(n=1). Adverse events were observed in 14.23% (n=5) patients: GI bleeding(n=3), esophageal stricture requiring balloon dilation(n=1), recurrent vomiting(n=1).
The technical success in exclusion of fistulas / anastomotic dehiscences was 100%(32). There were 5 deaths: sepsis(n=3); aortoesophageal fistula 3 cm above the proximal edge of the stent (n=1) e probable pulmonary thromboembolism (n=1).
After a median stent implantation of 6 (1-18) weeks, a clinical success rate in fistula closure of 93%(26/28) was observed. In two patients with persistent fistulas after stent removal were successfully managed with 10 mm over-the-scope-clips. The clinical success of the stent in managing strictures with concomitant fistulas was 100%(13/13) and isolated stricture was 33%(1/3). One patient required endoscopic dilatation and the other underwent total gastrectomy.

Conclusion

The innovative design of the Luso-Cor. stent is very effective in managing fistulas and concomitant strictures after gastric bariatric and oncologic surgery. The esophageal anchoring reduces the migration risk and facilitates the stent removal.

Introduction

Combination of benzodiazepines and opioids are effective for achieving moderate sedation for endoscopic procedures and can be delivered safely by endoscopists in patients with ASA Class I–III. Non-anaesthesiologist administration of propofol (NAAP)is only available in a few European countries and there is evidence that low-risk procedures can presumably be done with conventional moderate sedation regimens.^1.2

Aims & Methods

This study aimed to evaluate efficacy, safety and patient overall satisfaction in endoscopic procedures with moderate sedation by gastroenterologists (GIs).
A single-centre prospective study was carried out between April 2021 and February 2023, where 317 patients with indication for endoscopic procedure with sedation by GIs were evaluated and finally 264 included. Fifty-three patients were excluded for failure to obtain informed consent 38%(n=20), cognitive or hearing impairment 19% (n=10), ASA-IV or V 11%(n=6), presence of stoma 11%(n=6), absence of assistance after sedation 8%(n=4), anticipated intolerance or reaction to sedatives 4%(n=2), predicted difficult airway and ventilation 4%(n=2), poor bowel preparation unable to perform the exam 4%(n=2). Midazolam induction dose started at 0.05mg/kg, plus analgesia with pethidine at initial dose of 25 mg (maximum 50 mg), titrated until achieving score 3 or 4 in Ramsay scale. Nurse-assessed Gloucester comfort scale was used for patient comfort during procedures. Patients’ satisfaction was evaluated based on a final self-completion survey: satisfaction (5 levels); remembering the start of procedure (yes/no); remembering staying awake during procedure (yes/no), pain scale (0 to 10) and repeating the procedures under the same conditions (yes/no/maybe). Statistical analysis was performed using SPSS v27 (SPSS Inc., Chicago, IL, USA).

Results

The 264 patients included had mean age 64±13 years with 53%(n=139) men. The mean BMI was 27.1±5.3 kg/m². ASA classification: Class II 58%(n=156) and class III 20.8%(n=56). Anxiety or depression disorder was noted in 21%(n=54) and obstructive sleep apnea syndrome in 6%(n=16). Use of benzodiazepines was noted in 21%(n=58) and opioids in 5%(n=14).
In total, 309 endoscopic procedures were performed: 28%(n=87) gastroscopies and 72%(n=222) colonoscopies. Midazolam induction dose per protocol was met in 59% patients (n=156). Median midazolam dose at gastroscopy was 3.0 (3.0-5.0)mg and colonoscopy 5.0 (3.0-6.0)mg; median dose of pethidine was 25mg (0-50). Sedation target (Ramsay score ≤4) was reached in 44%(n=140) and absence or slight pain was verified in 74%(n=236) cases. Adverse events were noted in 8%(n=22), the majority mild, characterized by hypotension and/or transient hypoxemia rectified with oxygen therapy; one patient needed 24 hours hospitalization due to atrial fibrillation requiring chemical cardioversion. Most patients were at least satisfied with their procedures 82,5%(n=189/229), with no pain experienced in 53% cases (n=128/240). Among those who referred pain (0 to 10), the median was 3.0 (2.0-5.0). Even though the majority did remember the start 72%(n=191) or the course 56%(n=148) of the procedures, 82%(n=216) would repeat it under the same conditions.

Conclusion

Moderate sedation by gastroenterologists is safe and effective and should be implemented in low-risk procedures with patients ASA I-III, especially in countries where NAAP is unavailable. Compliance with midazolam induction dose to achieve the sedation target is important for patient satisfaction.

References

1. Early, D. S. et al. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointestinal Endoscopy 87, 327–337 (2018).
2. Dumonceau, J. M. et al. European curriculum for sedation training in gastrointestinal endoscopy: Position statement of the european society of gastrointestinal endoscopy (ESGE) and European society of gastroenterology and endoscopy nurses and associates (ESGENA). Endoscopy 45, 496–504 (2013).