1. Distributor (manufacturer)
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A comparative Study Comparing A New Anti-reflux Stent To A conventional open stent in the palliation of distal oesophageal cancer
Cynthia Kanagasundaram Jonathan Segal Anthony Leahy, Mark Fullard, Jeremy Livingstone
Watford Hospital West Hertfordshire Hospitals NHS Trust
Methods
A prospective study involving 40 patients with cancer involving the gastro-oesophageal junction.
All patients will have been previously deemed inoperable within the local multi-disciplinary team meeting.
Patients will receive either an anti-reflux stent (cardia-valve stent, Premier endoscopy) or a conventional open stent (ultraflex, Boston Scientific).
All stents will be partially covered and placed across the gastro-oesophageal junction.
Outcomes
Symptoms and quality of life will be measured using the European Organisation into Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30) and the oesophageal module European Organisation into Research and Treatment of Cancer questionnaire (EORTC QLQ-OES18).
The questionnaires will be recorded by the attending endoscopist/physician at weeks 0 and 1.
Patients will be requested not to take proton pump inhibitors or H2 antagonists for the first week after stent insertion (antacids allowed during this period).
Patients will be requested to finally complete the symptom questionnaires (via post/telephone) at month 3
Results
There were 15 Ultraflex stents and 8 cardiovalve stents that were followed up.
Baseline EORTC QLQ-OES18 showed no significant differences in baseline scores
The overall ultravalve group improved their reflux score by 5 and the cardiovalve improved by 6 points. This was not significant p=
Introduction
Oesophageal cancer is the sixth most common cause of death from cancer in the United Kingdom,.(1)
Oesophageal cancer has a 5 year survival rate of 10-15%.(2-3)
More than half of patients have inoperable disease at presentation.(4)
The goals of palliative therapy in patients with unresectable cancer are to ameliorate symptoms of dysphagia, treat complications, maintain oral intake, minimise hospital stay, relieve pain, eliminate reflux and regurgitation, prevent aspiration and ultimately improve their quality of life.(5)
Various therapies have been used to palliate dysphagia and one of the main methods to achieve this is the insertion of an oesophageal stent.
Oesophageal intubation with a self-expanding stent is the treatment of choice for stenosing tumours, where rapid relief of dysphagia in a one stage procedure is desirable.(6)
complications after stent insertion occur in approximately 30-35%.Complications seem to be higher when the stent crosses the gastro-oesophageal junction.(5)
There have been various stent designs marketed that incorporate an anti-reflux valve stent with a view to reducing this complication..
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Table 1: Design characteristics of marketed anti-reflux stents
Stent
Distributor (manufacturer)
Anti-reflux design
Diameter
Lengths
Partial covering
Z stent Dua
Cook Medical
Windsock
18/25mm
8, 10, 12, 14cm
Yes
FerX-Ella
UK Medical
(Ella-CS)
20/36mm
9, 10.5, 12, 13.5, 15, 16.5 cm
EGIS
BVM
16/24, 18/26, 20/28mm
4, 6, 8, 10, 12cm
Hanarostent EPV
Diagmed UK
(M.I. Tech)
S shape valve
22/28mm
12cm
Cardia-valve
Premier endoscopy
(Micro-Tech)
2 way oblique valve
20/26, 24/30mm
10, 12cm
Aim
To compare a new anti-reflux stent with a conventional open stent in the palliation of patients with distal oesophageal cancer
Conclusion
There were no significant differences in EORTC QLQ-OES18 scores between the two groups at week one
There were no significant improvements in reflux scorebetween the two groups.
There appeared to have similar quality of life profiles at week one post insertion.
This is a small study and longer time follow up data is currently ongoing with 3 month follow up data of patients currently being analysed
Types of Stents
Type of stents
References
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Sagar PM, Gauperaa T, Sue-Ling H. An audit of the treatment of cancer of the oesophagus, Gut 1994; 35:
Sharma P, Kozarek R. American College of Gastroenterology Practice Guideline: Role of esophageal stents in benign and malignant diseases. Am J Gastro 2010;105:
Dua KS, Kozarek R, Kim J et al. Self-expanding metal esophageal stent with anti-reflux mechanism. Gastrointest Endosc 2001; 53:
Allum W, Blazeby J, GriffIn S. Guidelines forthe management of oesophageal and gastric cancer. Gut 2011; 60:
Wenger U , Johnsson E , Arnelo U et al. An antireflux stent versus conventional stents for palliation of distal esophageal or cardia cancer: a randomized clinical study. Surg Endosc 2006; 20:
Laasch HU, Marriott A, Wilbraham L et al. Effectiveness of open versus antireflux stents for palliation of distal esophageal carcinoma and prevention of symptomatic gastroesophageal reflux . Radiology 2002; 225:
Shim CS, Jung IS, Cheon YK et al. Management of malignant stricture of the esophagogastric junction with a newly designed self-expanding metal stent with an antireflux mechanism. Endoscopy 2005; 37:
Power C, Byrne P, Lim K et al. Superiority of anti-reflux stent compared with conventional stents in the palliative management of patients with cancer of the lower esophagus and esophago-gastric junction: results of a randomized trial. Dis Oesophagus 2007; 20:
Homs MY, Wahab PJ, Kuipers EJ et al. Esophageal stents with antireflux valve for tumors of the distal esophagus and gastric cardia: a randomized trial. Gastrointest Endosc 2004; 60:
Sabharwal T, Gulati M, Fotiadis N et al. Randomised comparison of the FerX Ella antireflux stent and the ultraflex stent: proton pump inhibitor combination for prevention of post-stent reflux in patients with esophageal carcinoma involving the esophago-gastric junction. J Gastroenterol Hepatol 2008; 23(5):