The authors concluded that self-expanding plastic stents (SEPS) were moderately effective and apparently safe in patients with benign oesophageal strictures. Therefore, SEPS placement was a potentially attractive alternative to repeated endoscopic dilation. Potential methodological limitations in the review process and unclear study quality made that the reliability of the conclusions uncertain.

To evaluate the effectiveness and safety of self-expanding plastic stents (SEPS) in patients with benign oesophageal strictures.

PubMed and EMBASE were searched up to April 2009 for published English-language articles. Search terms were reported. Reference lists of identified articles were searched for additional studies. Review articles, position papers, editorials, commentaries, abstracts and book chapters were excluded.

Studies of SEPS positioning in patients with benign oesophageal strictures recurrent or refractory to multiple endoscopic dilations were eligible for inclusion in the review if they reported on post-stenting clinical follow-up. Eligible outcomes were clinical success rate (defined by the authors as clinical remission without need for further endoscopic or surgical treatment following SEPS removal or migration), technical success (correct positioning of the SEPS) and complications (stent migration within four weeks, need for re-intervention and clinical complications).

Most of the included studies were conducted between 2003 and 2008 in USA and Europe (none in UK). All included patients had dysphagia and largely presented with post-surgical stricture in the upper oesophagus. Other types of structure included corrosive, postradiation and peptic. More than half of the patients were male (60%). Overall mean age across the studies was 51 years. One study was conducted in paediatric patients.

The authors did not state how many reviewers carried out study selection.

The authors did not state that they carried out a quality assessment of included studies.

Data were extracted on the proportion of patients with each outcome and 95% confidence intervals (CI) were presented. Authors were contacted for data clarification, where necessary.

Two reviewers carried out data extraction; disagreements were resolved by consensus.

A narrative synthesis was provided. Subgroup analyses were carried out according to stricture site (upper, mid or lower oesophagus), stricture length (≤2cm versus ≥2 cm), males versus females, younger (<60 years) versus older patients and stricture aetiology. Differences in data were explored with the X² test or Fisher's exact test.

Ten studies were included in the review (total n=185, 130 treated patients, median sample size 16, range one to 40): seven retrospective studies and three prospective studies. Median follow-up after SEPS insertion was 13 months (range six to 23 months).

Effectiveness: Treatment was successful in 98% (95% CI 96% to 100%) of patients. Overall clinical success rate was 52% (95% CI 44% to 61%). A statistically significant higher level of success was reported in patients with strictures in the mid or lower oesophagus compared with the upper oesophagus (54% versus 33%). A trend for higher success was noted in patients with more than 2cm stricture length compared with those with shorter strictures (49% versus 28%). There were no other reported differences in clinical success rates.

Complications: Early stent migration was 23% (95% CI 14 to 32%; eight studies). The re-intervention rate was 21% (95% CI 14% to 28%; nine studies). Overall clinical complication rate was 9% (95% CI 4% to 14%), which comprised incidences of perforation (three cases), bleeding (three cases), tracheal compression or chest pain (two cases), inability to remove the stent (two cases), death (due to massive bleeding in one case) and tracheal fistula (one case).

SEPS were moderately effective and appeared to be relatively safe. SEPS placement was a potentially attractive alternative to repeated endoscopic dilation.

The review addressed a clear question and this was supported by potentially reproducible inclusion criteria. The necessity for broad study design criteria appeared justified given the rarity of the disorder. The search strategy accessed two relevant electronic databases. The limitation to published English-language studies mean that relevant articles may have been missed. Associated biases could not be ruled out. The review process was poorly reported; only data extraction demonstrated any attempt to minimise error and bias. The absence of any reported study quality assessment meant that the reliability of the included studies and their subsequent synthesis could not be judged adequately. Study details were presented. The chosen method of synthesis appeared to be appropriate, given the apparent clinical heterogeneity.

The authors' conclusions reflected the evidence presented, although endoscopic dilation was not compared directly and readers should judge the clinical relevance of the reported mortality rate. Potential methodological limitations in the review process and unclear study quality made the extent to which these conclusions are reliable uncertain.

Practice: The authors stated that this review supported use of SEPS before referring patients with benign oesophageal strictures to surgery.

Research: The authors stated that further studies were needed to investigate the most effective size of stent and duration of stent placement.

None stated.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.