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Summary

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References

Background  Placement of self-expanding metal stents (SEMS) or plastic stents (SEPS) has emerged as a minimally invasive treatment option for benign oesophageal ruptures and leaks; however, it is not clear which stent type should be preferred.

Aim  To assess clinical effectiveness and safety of treating benign oesophageal ruptures and anastomotic leaks with temporary placement of a stent with special emphasis on different stent designs.

Methods  A pooled analysis was performed after searching PubMed and EMBASE databases for studies regarding placement of fully covered and partially covered SEMS (FSEMS and PSEMS) and SEPS for this indication. Data were pooled and evaluated for clinical outcome, complications and survival.

Results  Twenty-five studies, including 267 patients with complete follow-up on outcome, were identified. Clinical success was achieved in 85% of patients and was not different between stent types (SEPS 84%, FSEMS 85% and PSEMS 86%, = 0.97). Time of stent placement was longest for SEPS (8 weeks) followed by FSEMS and PSEMS (both 6 weeks). In total, 65 (34%) patients had a stent-related complication. Stent migration occurred more often with SEPS [= 47 (31%)] and FSEMS [= 7 (26%)] than with PSEMS [= 2 (12%), ≤ 0.001], whereas there was no significant difference in tissue in- and overgrowth between PSEMS [12% vs. 7% (FSEMS) and 3% (SEPS), = 0.68].

Conclusions  Although there is a lack of randomised controlled trials, it seems that covered stent placement for a period of 6–8 weeks is safe and effective for benign oesophageal ruptures and anastomotic leaks to heal. As efficacy between different stent types is not significantly different, stent choice should depend on expected risk of stent migration (self-expanding plastic stents and fully covered self-expanding metal stents) and, to a minor degree, on expected risk of tissue in- or overgrowth (partially covered self-expanding metal stents).


Introduction

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References

Oesophageal ruptures and leaks are rare, but may occur spontaneously, as in Boerhaave syndrome, or as a complication after an endoscopic or surgical procedure.1 Despite improvement in diagnostic procedures and (surgical) interventions, ruptures and leaks in the oesophagus are still potentially life-threatening injuries associated with a high morbidity and mortality if treated surgically.2–8

Surgical treatment has long been the ‘gold standard’ for these emergencies.1, 5, 9–12 Over the past few years, new minimally invasive endoscopic treatment options have emerged, i.e. closure with clips or sutures, sealing with biological glue and sealing with stent placement.13

Endoscopic stent placement is an effective treatment for malignant dysphagia in a palliative setting.14 Recently, a good outcome with low morbidity and mortality has been reported for treating benign oesophageal ruptures and leaks with temporary placement of a fully (FSEMS) or partially (PSEMS) covered self-expanding metal stent or a self-expanding plastic stent (SEPS).15–20 Stents were found to be able to effectively seal oesophageal leaks or ruptures and allow healing of the oesophageal wall, particularly when concurrent adequate drainage of fluid collections in the mediastinum or pleural cavity is performed. The main drawbacks of stent placement are stent migration and tissue in- or overgrowth, both of which necessitate a repeat intervention. Reactive nonmalignant tissue in- or overgrowth is mainly causing a problem when stents are inserted for a longer period and has been reported to occur more commonly with PSEMS than with FSEMS or SEPS.21–23

Experience with temporary stent placement for benign oesophageal ruptures or anastomotic leaks is until now only limited with most studies reporting small case series. In addition, studies comparing SEPS, FSEMS and PSEMS for the treatment of benign oesophageal ruptures and leaks are not available.

We therefore performed a systematic review of the currently available literature to assess clinical effectiveness and safety of treating benign oesophageal ruptures and anastomotic leaks with temporary placement of a stent with special emphasis on different stent designs.

Methods

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References

Literature search

A literature search was performed in MEDLINE and EMBASE to identify all related studies on stent placement for benign oesophageal ruptures or leaks. Each search was performed for studies in the English language until 30 June 2010, using the key words esophagus, esophageal, rupture, leakage, leak, perforation, tear, Boerhaave syndrome and stent. Boolean operators (NOT, AND, OR) were used, when appropriate, to widen or narrow the search. Then, a scan of the reference lists of each article was undertaken to identify other relevant articles that were missed in the search. Studies that met the following inclusion criteria were selected for our pooled analysis: (i) patients with a benign oesophageal rupture or leak; (ii) endoscopic stent placement; and (iii) results on a specific stent design (SEPS, FSEMS and PSEMS). Studies that were not in the English language, letters, editorials, reviews, animal studies, case reports with fewer than four patients, and studies in patients with a malignant indication for stent placement were excluded. Patients with incomplete follow-up after stent placement and patients dying from an oesophageal malignancy within 1 year of follow-up were excluded from our analysis.

Date extraction

Data on year of publication, country of origin, stent design, total number of patients included, number of patients with complete follow-up, gender, age, aetiology and size of rupture or leak, additional drainage of fluid collections in the mediastinum or pleural cavity, time between rupture or leak and stent placement, technical success of stent placement and removal, clinical success, total time of stent placement, procedure- and stent-related complications, re-interventions and mortality were extracted. All abstracts and titles of studies were screened and data extraction from the selected studies were independently performed by two investigators (PVB and AS) and differences of opinion were resolved by consensus opinion.

Definitions

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References

We used the following definitions:

  • (i)
     Time of stent placement: time between stent placement and removal
  • (ii)
     Successful sealing: sealing a perforation without complications
  • (iii)
     Clinical success: healed perforation at the end of follow-up without fatal complications
  • (iv)
     Technical success: technically successful stent placement and removal
  • (v)
     Complication: adverse event due to the stent placement procedure (procedure-related complication except pneumonia, for example, perforation and haemorrhage) or type of stent used (stent-related complication, for example, stent migration, tissue in- or overgrowth, etc.)
  • (vi)
     Re-intervention: endoscopic or surgical procedure needed to resolve complications or because of failure of stent placement

Statistical analysis

After data extraction, data were pooled according to stent design. Data comparison between the stent designs was performed using the Chi-squared test. A P-value < 0.05 was considered statistically significant. Statistical analyses were conducted using spss version 15 (SPSS Inc., Chicago, IL, USA).

Results

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References

Search results

We detected 392 articles in MEDLINE and 601 articles in EMBASE. Of these, 25 articles met our inclusion criteria for the pooled analysis (Figure 1). A total of 13 studies reported results on SEPS placement (15;16;18;24-32), five on FSEMS placement (13;33-36) and seven on PSEMS placement for the treatment of benign oesophageal ruptures and leaks (19;37-42).

image

Figure 1.  Flowchart of search history on stents for benign oesophageal leaks and ruptures.

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Descriptive analysis

All studies were published between 2001 and 2009. Sixteen studies were performed in Europe, seven in the US, one in Australia and one in China (Table 1). Twenty-five studies evaluated 267 patients with completed follow-up, of whom 159 were treated with SEPS, 34 with FSEMS and 74 with PSEMS. Most of the stents used in the studies were 18-mm diameter stents. Overall, 71% of the patients were male and the mean age across studies was 60 (range, 17–91) years.

Table 1.   Baseline characteristics of studies on stent placement for benign oesophageal leaks and ruptures
ReferenceYearCountryStent typeNPatients with complete FU, n (%)Males, n (%)Age, mean (range)
  1. SEPS, self-expanding plastic stents; FSEMS, fully covered self-expanding metal stents; PSEMS, partially covered self-expanding metal stents.

  2. * Computation limited to studies in which this information was provided.

SEPS
 Freeman et al.332009USPolyflex1919 (100) 48 (26–67)
 Pennathur et al.342008USPolyflex388 (21)  
 Freeman et al.332007USPolyflex1717 (100) 54 (17–91)
 Fukumoto et al.352007USPolyflex44 (100)0 (0)38 (23–58)
 Kiev et al.362007USPolyflex1413 (93)8 (57)53 (21–86)
 Ott et al.372006GermanyPolyflex3512 (34)9 (75)65 (54–95)
 Freeman et al.152007USPolyflex2121 (100) 54 (14–93)
 Schubert et al.262005GermanyPolyflex1212 (100)8 (67)67 (37–84)
 Radecke et al.382005GermanyPolyflex397 (18)  
 Langer et al.182004AustriaPolyflex2424 (100)18 (75)61 (37–84)
 Gelbmann et al.392004GermanyPolyflex99 (100)  
 Evrard et al.232004BelgiumPolyflex214 (19)4 (100)62 (45–78)
 Hunerbrein et al.162004GermanyPolyflex199 (47) 62 (49–74)
 Total   272159 (58)47 (64)*57 (17–91)*
FSEMS
 Amrani et al.132009FranceNiti-S/Hanaro94 (44)1 (25)58 (34–83)
 Babor et al.402009AustraliaElla Boubella77 (100)5 (71)66 (36–84)
 Salminen et al.412009FinlandHanaro108 (80)6 (75)58 (51–86)
 Han et al.422006ChinaMushroom shaped88 (100)8 (100)61 (38–71)
 Roy Choudhury et al.432001UKUltraflex/Telestep147 (50)6 (86)67 (48–83)
 Total   4834 (71)26 (76)62 (34–86)
PSEMS
 Leers et al.442009GermanyUltraflex317 (23)  
 Tuebergen et al.452008GermanyUltraflex3210 (31)6 (60)65 (44–81)
 Fischer et al.192006GermanyUltraflex1513 (87)11 (85)56 (47–81)
 Johnsson et al.462005SwedenUltraflex2213 (62)  
 Wadhwa et al.472003USUltraflex/Wallst/Zstent135 (38)  
 Doniec et al.322003GermanyUltraflex2115 (71)  
 Siersema et al.482003The NetherlandsFlamingoWallst/Ultraflex1111 (100)8 (73)59 (29–87)
 Total   14574 (51)25 (74)*60 (29–87)*
Overall   465267 (57)98 (71)*60 (17–91)*

The aetiology of the ruptures was an anastomotic leak in 137 (51%) patients, iatrogenic (postendoscopic) in 66 (25%) patients, Boerhaave’s syndrome in 46 (17%) patients, a (benign) fistula in nine (4%) patients and other causes in the remaining eight (3%) patients. In the PSEMS group, four (14%) perforations occurred during dilation, with two (7%) of these performed for achalasia. Two (8%) other perforations occurred during rigid oesophagoscopy, two (2%) during endoscopic retrograde cholangiopancreatography (ERCP) and 18 (69%) following endoscopic procedures of unknown origin. In the FSEMS group, one (20%) perforation occurred after dilation for achalasia, one (20%) post-endoscopic mucosal resection (EMR) and three (60%) following endoscopic procedures of unknown origin. In the SEPS group, seven (22%) perforations occurred during dilation, three (10%) during endoscopic ultrasound (EUS), three (10%) during stent removal, two (7%) as a consequence of taking biopsies, one (3%) post-EMR and 17 (48%) following endoscopic procedures of unknown origin.

In all but five studies (18;27;32;37;40), detailed data on size of rupture or leak were missing. In these five studies, rupture or leak size varied between 10 and 30 mm and/or consisted of 20–100% of the circumference. The overall mean time between occurrence of rupture or leak and stent placement was 10 (range, 50 min to 72 days) days.

Concurrent drainage of fluid accumulations outside the oesophageal lumen was performed in 59% of patients (55% of patients with SEPS, 60% of patients with FSEMS and 61% of patients with PSEMS; Table 3).

Table 3.   Pooled analysis of outcome of studies reporting on SEPS, FSEMS and PSEMS placement for benign oesophageal leaks and ruptures
StentsNAetiology, n (%) IatrogenicTime before stent placement (days)Technical success, n (%)Drainage, n (%)Sealing rate, n (%)Complications, n (%)Re-intervention, n (%)Time stent in place (weeks)Clinical success, n (%)Mortality, n (%)
Anastomotic leakPostendoscopyBoerhaave syndromeFistulaOtherStent placementStent removalMigrationTissue growthEndoscopic procedureSurgical procedure
  1. SEPS, self-expanding plastic stents; FSEMS, fully covered self-expanding metal stents; PSEMS, partially covered self-expanding metal stents.

  2. Computation limited to studies in which information was provided.

SEPS15992 (58)33 (21)23 (14)8 (5)2 (1)12.5157 (99)90 (99)46 (55)135 (89)47 (31)5 (3)41 (26)11 (14)8128 (84)16 (11)
FSEMS3418 (53)5 (15)11 (32)  1634 (100)23 (100)21 (60)31 (91)7 (26)2 (7)9 (26)3 (11)629 (85)6 (18)
PSEMS7427 (37)28 (38)28 (38)1 (1)6 (8)3.840 (98)26 (92)20 (61)58 (94)2 (12)2 (12)3 (13)4 (14)6.135 (85)9 (18)
Total*267137 (51)66 (25)46 (17)9 (4)8 (3)10.5231 (99)139 (98)87 (59)224 (88)56 (29)9 (5)53 (25)18 (13)7.2192 (85)31 (13)

The mean time between rupture or leak and stent placement was shortest for PSEMS placement (4 days), followed by SEPS placement (13 days) and longest for FSEMS placement (16 days). Total time of stent placement was longest for SEPS (8 weeks, range 3–19 weeks), followed by PSEMS and FSEMS placement (both 6 weeks, range 3–17 and 5–9 weeks respectively). Results of the individual studies are summarised in Tables 2a–c.

Table 2.   Outcome of studies on SEPS placement for benign oesophageal leaks and ruptures
ReferenceNAetiology, n (%) IatrogenicTime before stent placement (days)Technical success, n (%)Drainage, n (%)Sealing rate, n (%)Complications, n (%)Re-intervention, n (%)Time stent in place (weeks)Clinical success, n (%)Mortality, n (%)
Stent placementStent removal
Anastomotic leakPostendoscopyBoerhaave syndromeFistulaOtherMigrationTissue growthEndoscopic procedureSurgical procedure
  1. SEPS, self-expanding plastic stents; FSEMS, fully covered self-expanding metal stents; PSEMS, partially covered self-expanding metal stents.

  2. * Computation limited to those studies in which this information was provided.

(a)
Freeman et al.3319  19 (100)  119 (100)19 (100)9 (47)17 (89)4 (21)0 (0)4 (21)2 (11)317 (89)0 (0)
Pennathur et al.3485 (63)3 (37)    8 (100)  6 (75)7 (88) 7 (88)0 (0) 3 (38)0 (0)
Freeman et al.20179 (53)8 (47)   217 (100)17 (100)6 (35))16 (94)3 (190 (0)3 (18)1 (6)7.416 (94)0 (0)
Fukumoto et al.3543 (75)  1 (25)  4 (100)4 (100)3 (75)3 (75)2 (50)1 (25)2 (50)1 (25)63 (75)0 (0)
Kiev et al.36135 (38)4 (30)2 (16) 2 (16) 13 (100)13 (100)13 (100)13 (100)3 (23)0 (0)3 (23)0 (0) 13 (100)1 (8)
Ott et al.37125 (42)3 (25)1 (8)3 (25)  12 (100) All infected areas11 (92)4 (33)0 (0)4 (33)0 (0) 5 (42)5 (42)
Freeman et al.152112 (57)9 (43)   1221 (100)20 (95) 20 (95)5 (24)1 (5)5 (24)1 (5)7.320 (95)1 (5)
Schubert et al.261212 (100)    1512 (100) 10 (93)12 (100)2 (17)0 (0)3 (25)0 (0)411 (92)0 (0)
Radecke et al.3873 (43)4 (57)    7 (100)          
Langer et al.182424 (100)    1922 (92)9 (100) 22 (92)9 (38)0 (0)5 (21)9 (38) 21 (88)6 (25)
Gelbmann et al.3995 (56)3 (33)1 (11)   9 (100)6 (100)9 (100)3 (33)3 (33)1 (11)1 (11)0 (0)19.26 (66)3 (33)
Evrard et al.234   4 (100) 224 (100)4 (100) 4 (100)3 (75)0 (0)0 (0)0 (0)11.34 (100)0 (0)
Hunerbrein et al.1699 (100)    7.29 (100)9 (100)9 (100)8 (89)2 (22)0 (0)2 (22)0 (0)4.19 (100)0 (0)
Total*15992 (58)33 (21)23 (14)8 (5)2 (1)12.5157 (99)90 (99)46 (55)135 (89)47 (31)5 (3)41 (26)11 (14)8128 (84)16 (11)
(b)
Amrani et al.1342 (50)2 (50)   124 (100)4 (100) 4 (100)2 (50)0 (0)3 (75)0 (0)54 (100)0 (0)
Babor et al.407  7 (100)  67 (100)7 (100)4 (57)7 (100)4 (57)0 (0)4 (57)0 (0)9.47 (100)0 (0)
Salminen et al.4181 (13)3 (37)4 (50)  128 (100)4 (100)6 (75)6 (75)1 (13)1 (13)1 (13)3 (38)54 (50)3 (38)
Han et al.4288 (100)    348 (100)8 (100)8 (100)8 (100)0 (0)1 (13)0 (0)0 (0)4.58 (100)2 (25)
Roy Choudhury4377 (100)    127 (100) 3 (43)6 (86)  1 (14)  6 (86)1 (14)
Total*3418 (53)5 (15)11 (32)  1634 (100)23 (100)21 (60)31 (91)7 (26)2 (7)9 (26)3 (11)629 (85)6 (18)
(c)
Leers et al.4472 (29)4 (57)  1 (14) 7 (100)       6 1 (14)
Tuebergen et al.45102 (20)4 (40)4 (40)   10 (100)5 (100)2 (20)8 (80)    3.9  
Fischer et al.1975 (71)2 (29)   50 min 7 (100)1 (14)7 (100)  1 (14)0 (0)3.57 (100)2 (29)
 61 (17)5 (83)   2.8 6 (100)6 (100)6 (100)   2 (33)2.86 (100)0 (0)
Johnsson et al.46132 (16)5 (38)1 (8) 5 (38)1112 (92)  12 (92)    2.59 (69)4 (31)
Wadhwa et al.4753 (60)1 (20)1 (20)    3 (100)  1 (20)0 (0)1 (20)0 (0)173 (60)2 (40)
Doniec et al.321511 (73)2 (13)1 (7)1 (7)   5 (71) 15 (100)       
Siersema et al.48111 (10)5 (45)5 (45)  1.311 (100) 11 (100)10 (91)1 (9)2 (18)1 (9)2 (18)710 (90)0 (0)
Total*7427 (37)28 (38)12 (16)1 (1)6 (8)3.840 (98)26 (92)20 (61)58 (94)2 (12)2 (12)3 (13)4 (14)6.135 (85)9 (18)

Outcome and survival

The overall technical success rate of stent placement was 99% and was not different between stent types (99% for SEPS, 100% for FSEMS and 98% for PSEMS, = 0.65; Table 3). Removal of SEPS and FSEMS was mostly uncomplicated (99% and 100% respectively); however, removal of PSEMS was reported as complicated in 8% (92% uncomplicated)(see below).

Clinical success was achieved in 85% of all patients and was not significantly different between SEPS (84%), FSEMS (85%) and PSEMS (86%) (= 0.97; Table 3). Mortality was 13% in all patients and was lowest with SEPS (11%) followed by FSEMS and PSEMS (both 18%). In most patients, the cause of death was a septic complication due to infected fluid or an abscess outside the oesophageal lining.

Complications and re-interventions

Eight (3%) patients had a procedure-related complication [bleeding (= 6) or perforation due to stent misplacement (= 2)], whereas in 65 (34%) patients, a stent-related complication was seen [stent migration (= 56), tissue in- or overgrowth (= 9)]. Stent migration occurred more often with SEPS [= 47 (31%)] and FSEMS [= 7 (26%)] than with PSEMS [= 2 (12%)] (≤ 0.001), whereas there was no significant difference in tissue in- or overgrowth between PSEMS [= 2 (12%)] than with FSEMS [= 2 (7%)] and SEPS [= 5 (3%)] (= 0.68).

An endoscopic re-intervention was performed in 53 (25%) patients; however, more with SEPS or FSEMS (both 26%, = 41 and 9 respectively) than with PSEMS (13%, = 3) (≤ 0.001). A surgical intervention for incomplete sealing, a procedure-related or stent-related complication, was performed in 13% of patients and was not different between stent designs.

Discussion

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References

To our knowledge, this is the first pooled data analysis reporting the results of different stent designs in patients with a benign oesophageal rupture or leak with results of 267 treated patients. There was a lack of randomised controlled trials. It is important to note that these results are only based on case series in which mainly small patient numbers were included.

Clinical success of stent placement, i.e. healing of the perforation or leak, was achieved in 85% of reported patients with no differences between PSEMS, FSEMS and SEPS. The mean time of stent placement that was needed for healing was 7 weeks and was not different between different stent types (range, 6–8 weeks). Animal studies have suggested that 4 weeks should be sufficient for tissue healing. Based on the results of this review, however, it seems advisable to remove oesophageal stents after a period of approximately 7 weeks.

An absolute prerequisite for healing is adequate drainage of fluid or abscess cavities that are in continuity with the perforation or leak.24 The time between the occurrence of an oesophageal rupture or leak and the actual treatment, either surgical or endoscopic, is one of the most critical prognostic factors (3;10;12;19). A longer delay between a rupture or leak and treatment is associated with a worsening of the prognosis due to septic complications from an infected fluid accumulation in the mediastinum or pleural cavity. Tilanus et al.25 found that extension of an oesophageal rupture into the pleural cavity was an independent risk factor for mortality. Most patients included in this review also died from septic complications due to an abscess cavity outside the oesophageal lining. Treatment, i.e. sealing the rupture or leak with concurrent drainage of fluid collections of abscess cavities in the pleural cavity, mediastinum and/or even peritoneal cavity should therefore be performed as early as possible. Drainage can be performed by endoscopic, radiological or surgical means.26

The mean time between oesophageal perforation or leak and stent placement was 11 days with significant differences between different stent types (FSEMS 16 days, SEPS 13 days and PSEMS 4 days). Remarkably, this did not result in differences in clinical success and mortality rates in favour of any stent type. This is probably because the time between perforation or leak and stent placement differed to a large extent between the included studies, varying between 50 minutes and 50 days!

Stent migration necessitating a re-intervention occurred in 25% of patients and was most commonly seen with fully covered stents, both SEPS (26%) and FSEMS (26%), compared with PSEMS (13%) (≤ 0.001). This is explained by the known reduced anchoring capacity of FSEMS and SEPS compared with PSEMS resulting in an increased migration rate of the former stent type.23, 27 Furthermore, as the far majority of these patients have no obstructive lesion keeping the stent in place, the relatively high rate of stent migration with fully covered stent designs is not unexpected.

In contrast, tissue in- and/or overgrowth was higher with PSEMS (12%) compared with SEPS (3%) and FSEMS (7%) (= 0.68), although this result was not significant. The cover of FSEMS en SEPS that is applied along its whole length prevents tissue from growing into the stent meshes. It has been shown that this benign tissue reaction particularly occurs at the uncovered part of FSEMS and is caused by a local fibrotic reaction and/or the proliferation of granulation tissue. This hyperplastic tissue reaction can be clinically manifest as early as 2 weeks after stent placement and also at a later stage.28 Moreover, tissue in- and/or overgrowth may complicate removal of PSEMS in patients, resulting in a second oesophageal perforation.29 A technique to remove embedded PSEMS is to place a fully covered stent of the same diameter inside the FSEMS. This so-called stent-in-stent method causes necrosis of the hyperplastic tissue in- and/or overgrowth. In our experience, both these stents can be removed uneventfully after a period of 7–14 days.30

Although all three stent designs were found to be effective in sealing benign oesophageal ruptures or leaks, they all have their pros and cons. The main limitations of the presently used stent types are migration and hyperplastic tissue in- and/or overgrowth. These stent types are as yet not available in a covered version. Another option could be the use of biodegradable formulations to cover ruptures or anastomotic leaks. This material has been shown to stimulate connective tissue and vascular ingrowth and displays only minor hyperplastic tissue formation.31 The technique to apply this material into an oesophageal leak or rupture needs, however, further development.

The mortality rate associated with stent placement for this indication (13%) may well compare favourably with surgical management (12–50%).19 There is currently no guideline as regards which type of oesophageal rupture or leak should be treated with stent placement or primary surgery. Stent placement has been proposed for ruptures or leaks <70% of the circumference, with surgery being reserved for larger ruptures or leaks.26 However, Doniec et al.32 reported a patient with a complete dehiscence that was treated with stent placement, resulting in complete closure without a complicated course. The only true evidence will come from a randomised trial comparing these two treatment modalities in a well-defined population. Nevertheless, the limited number of patients for such a trial and the promising results of stent placement as are summarised in this review make it difficult if not impossible to perform such a trial.

This review has several limitations which should be taken into account before concluding that a particular stent type is favourable in patients with a benign oesophageal rupture or leak. First, no randomised trials have been conducted. It is important to note that these results are only based on case series in which mainly small patient numbers were included. This is probably due to the limited number of patients in each centre. Moreover, both FSEMS and PSEMS are not approved by the Food and Drug Administration (FDA) for temporary use in benign indications.

Second, a variety of treatment protocols have been employed in the included studies. In some patients, stent removal or exchange was performed at shorter intervals than in others and concurrent treatment, such as drainage of fluid collections or abscesses, was also not standard treatment in all studies. Consequently, this could have affected clinical success rate, but also complication and mortality rates.

Furthermore, it was not possible to analyse outcome on stent placement based on aetiology of the underlying disorder due to a lack of data in the source papers.

Finally, selection bias cannot be excluded in this patient group, as it has still not been elucidated which patients could benefit from stenting and which patients from primary surgery.

In conclusion, this review demonstrates that covered stents placed for a period of 6–8 weeks are effective and safe for benign oesophageal ruptures or anastomotic leaks to heal. A prerequisite for successful stent placement is adequate drainage of fluid collections in the mediastinum or pleural cavity. As efficacy between PSEMS, FSEMS and SEPS was not found to be significantly different, stent choice should depend on expected risks of stent migration and/or tissue in- or overgrowth with a particular stent type. We are increasingly using fully covered stents, particularly FSEMS, for this indication, as these are flexible enough and when used in large diameters (23 mm body diameter) show acceptable migration rates. Further randomised trials are, however, needed to compare different stent types, on one hand, and the ideal stent design that comes out of these trials with surgical treatment, on the other hand; however, due to the limited number of patients, this is unlikely to occur.

Acknowledgements

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References

Declaration of personal interests: P. D. Siersema is an advisory board member and speaker for Boston Scientific. He is also a speaker for Cook Ireland Ltd. He has received research support from Boston Scientific and Cook Ireland Ltd. Declaration of funding interests: None.

References

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Definitions
  6. Results
  7. Discussion
  8. Acknowledgements
  9. References
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