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Esophageal Stents for Malignant
    and Benign Indications
        Peter D. Siersema, MD, PhD
  Dept. of Gastroenterology and Hepatology
Stents in the esophagus

• Malignant obstruction

• Esophagorespiratory fistula

• Benign stricture

• Benign rupture or anastomotic leak
Esophageal stents - issues

• Complications/recurrent dysphagia
Stents - Complications and
      recurrent dysphagia
Procedure-related complications (5%)
  • Perforation, (aspiration) pneumonia, (severe) pain

Late complications (10-15%)
  • Hemorrhage, fistula formation

Minor complications (10-20%)
  • (Minor) pain, gastro-esophageal reflux
Treatment of reflux
Antireflux valve (Retrofit)
Treatment of reflux
Antireflux valve (Retrofit)
Stents - Complications and
      recurrent dysphagia
Procedure-related complications (5%)
  • Perforation, (aspiration) pneumonia, (severe) pain

Late complications (10-15%)
  • Hemorrhage, fistula formation

Minor complications (10-20%)
  • (Minor) pain, gastro-esophageal reflux

Recurrent dysphagia (20-35%)
  • Stent migration, tissue in- and overgrowth, food obstruction
Recurrent dysphagia




Tissue in- and   Food obstruction   Stent migration
overgrowth
Esophageal stents - issues

• Complications/recurrent dysphagia

• Stents for malignant indications
Esophageal stents




   Niti-S     SX-Ella    Alimaxx-E   Polyflex     Wallflex PC   Evolution   Ultraflex
(Taewoong)   (Ella CS)    (Merit)     (Boston Scientific)       (Cook)        (BS)
Esophageal stents - issues

• Complications/recurrent dysphagia

• Stents for malignant indications

• Stents for benign strictures
Benign obstruction
           Stent choice
Fully covered stents

• Plastic (SEPS):
  − Polyflex

• Nitinol (SEMS):
  −Niti-S
  −SX-Ella
  −Alimaxx-E
  −Wallflex FC
  −Evolution FC
                             Siersema et al. Gastrointest Endosc 2009
Benign obstruction
           Stent choice
Fully covered stents
                       Efficacy:
• Plastic (SEPS):      −Long-term: 40-45%
  − Polyflex
                       Pro:
                       −Removable
• Nitinol (SEMS):
  −Niti-S              Contra:
  −SX-Ella             −Recurrent dysphagia
                          • Stent migration
  −Alimaxx-E
                          • Tissue overgrowth
  −Wallflex FC         −Stent removal is indicated
  −Evolution FC
                                 Dua et al. Am J Gastroenterol 2008
                                 Siersema et al. Gastrointest Endosc 2009
Benign obstruction
           Stent choice
Fully covered stents

• Plastic (SEPS)
     Polyflex (FDA approved)

•Nitinol stents (SEMS)
      Wallflex FC

Biodegradable stents

• Ella BD stent
                               Siersema et al. Gastrointest Endosc 2009
                               Repici et al. Gastrointest Endosc 2010 (in press)
Mr. S, 68 yrs




4 weeks after ELLA BD stent placement; dysphagia score: 0
Mr. S, 68 yrs




8 weeks after ELLA BD stent placement; dysphagia score: 0
Mr. S, 68 yrs




16 weeks after ELLA BD stent placement; dysphagia score: 0
Recurrent dysphagia at 20 weeks    2nd ELLA BD stent
Benign obstruction
           Stent choice
Fully covered stents

• Plastic (SEPS)         Efficacy:
     Polyflex            − Long-term: 40-45%

                         Pro:
•Nitinol stents (SEMS)   − Stent removal not necessary
      Wallflex FC        − Migration low

Biodegradable stents     Contra:
                         − Tissue ingrowth (uncovered mesh)
                         − Repeat stent placement
• Ella BD stent
                                Siersema et al. Gastrointest Endosc 2009
                                Repici et al. Gastrointest Endosc 2010 (in press)
Esophageal stents - issues

• Complications/recurrent dysphagia

• Stents for malignant indications

• Stents for benign strictures

• Stents for benign ruptures and anastomotic leaks
Benign rupture/leak
       Treatment algorithm

     Small (<2 cm)                Intermediate (>2 cm)                      Large
(<25% of circumference)           (>25% and <50-70%)                      (>50-70%)




      Stricture (-)      Stricture (+)




  <1 cm        <1 cm
                                                           ??


SEALANT        ENDOCLIP                    STENT                         SURGERY


                 Siersema. Chapter 19: Esophageal perforation In: Tham T, Collins J and Soetikno R, eds.
                 Gastrointestinal Emergencies Oxford: Blackwell Publishing Ltd 2008
Benign rupture/leak
       Treatment algorithm

     Small (<2 cm)              Intermediate (>2 cm)                      Large
(<25% of circumference)         (>25% and <50-70%)                      (>50-70%)




                                                         ??


                                         STENT


               Siersema. Chapter 19: Esophageal perforation In: Tham T, Collins J and Soetikno R, eds.
               Gastrointestinal Emergencies Oxford: Blackwell Publishing Ltd 2008
Benign rupture/leak
          Stent choice
Fully covered stents
• Polyflex
• Niti-S
• SX-Ella
• Alimaxx-E
• Evolution FC
• Wallflex FC




                             Siersema et al. Gastrointest Endosc 2009
Benign rupture/leak
          Stent choice
Fully covered stents
• Polyflex
• Niti-S
• SX-Ella              Pro:
                       - Incomplete sealing (?)
• Alimaxx-E
• Evolution FC
• Wallflex FC




                                  Siersema et al. Gastrointest Endosc 2009
Benign rupture/leak
          Stent choice
Fully covered stents

Partially covered stents
• Ultraflex
• Evolution PC
• Wallflex PC




                             Siersema et al. Gastrointest Endosc 2009
Benign rupture/leak
          Stent choice
Fully covered stents

Partially covered stents
• Ultraflex      Pro:
                 - More complete sealing (?)
• Evolution PC
                 - Success rate (n=52): 76% (i.t.t. 65%)
• Wallflex PC
                 Contra:
                 - Repeat stenting (83 stents (52 pats.)) (q 3-4 wks.)
                 - Complications (migration, tissue in-/overgrowth)
                      Tissue overgrowth: stent-in-stent technique

                                        Siersema et al. Gastrointest Endosc 2009
                                        van Boeckel et al. Surg Endosc (submitted)
                                        Hirdes et al. Am J Gastroenterol 2010 (in press)
Stent-in-stent technique

• Embedded stent visualized during
  endoscopy

• Insert second, fully covered stent
  inside embedded stent
   – with similar length + diameter       HV-ELLA stent
   – at level of tissue hyperplasia

• Stent-in-stent for 10-14 days in situ

• Radial force induces pressure
  necrosis of hyperplastic tissue
                                          Polyflex stent
Esophageal stents - issues

• Complications/recurrent dysphagia

• Stents for malignant indications

• Stents for benign strictures

• Stents for benign ruptures and anastomotic leaks


→Future developments
Esophageal stents - Future

Malignant esophageal strictures:
   – (New design) covered biodegradable stents
   – Stents plus radiation therapy (brachytherapy)
   – Bridge-to-Surgery
Esophageal stents - Future

Malignant esophageal strictures:
   – (New design) covered biodegradable stents
   – Stents plus radiation therapy (brachytherapy)
   – Bridge-to-Surgery


Benign esophageal strictures or ruptures:
   – (New design) covered biodegradable stents
   – Non-traumatic, more flexible (nitinol) stents
   – Stents with antifibrotic agents incorporated

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Endoscopy in Gastrointestinal Oncology - Slide 8 - P.D. Siersema - Esophageal stents for malignant and benign indications

  • 1. Esophageal Stents for Malignant and Benign Indications Peter D. Siersema, MD, PhD Dept. of Gastroenterology and Hepatology
  • 2. Stents in the esophagus • Malignant obstruction • Esophagorespiratory fistula • Benign stricture • Benign rupture or anastomotic leak
  • 3. Esophageal stents - issues • Complications/recurrent dysphagia
  • 4. Stents - Complications and recurrent dysphagia Procedure-related complications (5%) • Perforation, (aspiration) pneumonia, (severe) pain Late complications (10-15%) • Hemorrhage, fistula formation Minor complications (10-20%) • (Minor) pain, gastro-esophageal reflux
  • 7. Stents - Complications and recurrent dysphagia Procedure-related complications (5%) • Perforation, (aspiration) pneumonia, (severe) pain Late complications (10-15%) • Hemorrhage, fistula formation Minor complications (10-20%) • (Minor) pain, gastro-esophageal reflux Recurrent dysphagia (20-35%) • Stent migration, tissue in- and overgrowth, food obstruction
  • 8. Recurrent dysphagia Tissue in- and Food obstruction Stent migration overgrowth
  • 9. Esophageal stents - issues • Complications/recurrent dysphagia • Stents for malignant indications
  • 10. Esophageal stents Niti-S SX-Ella Alimaxx-E Polyflex Wallflex PC Evolution Ultraflex (Taewoong) (Ella CS) (Merit) (Boston Scientific) (Cook) (BS)
  • 11. Esophageal stents - issues • Complications/recurrent dysphagia • Stents for malignant indications • Stents for benign strictures
  • 12. Benign obstruction Stent choice Fully covered stents • Plastic (SEPS): − Polyflex • Nitinol (SEMS): −Niti-S −SX-Ella −Alimaxx-E −Wallflex FC −Evolution FC Siersema et al. Gastrointest Endosc 2009
  • 13. Benign obstruction Stent choice Fully covered stents Efficacy: • Plastic (SEPS): −Long-term: 40-45% − Polyflex Pro: −Removable • Nitinol (SEMS): −Niti-S Contra: −SX-Ella −Recurrent dysphagia • Stent migration −Alimaxx-E • Tissue overgrowth −Wallflex FC −Stent removal is indicated −Evolution FC Dua et al. Am J Gastroenterol 2008 Siersema et al. Gastrointest Endosc 2009
  • 14. Benign obstruction Stent choice Fully covered stents • Plastic (SEPS) Polyflex (FDA approved) •Nitinol stents (SEMS) Wallflex FC Biodegradable stents • Ella BD stent Siersema et al. Gastrointest Endosc 2009 Repici et al. Gastrointest Endosc 2010 (in press)
  • 15. Mr. S, 68 yrs 4 weeks after ELLA BD stent placement; dysphagia score: 0
  • 16. Mr. S, 68 yrs 8 weeks after ELLA BD stent placement; dysphagia score: 0
  • 17. Mr. S, 68 yrs 16 weeks after ELLA BD stent placement; dysphagia score: 0 Recurrent dysphagia at 20 weeks 2nd ELLA BD stent
  • 18. Benign obstruction Stent choice Fully covered stents • Plastic (SEPS) Efficacy: Polyflex − Long-term: 40-45% Pro: •Nitinol stents (SEMS) − Stent removal not necessary Wallflex FC − Migration low Biodegradable stents Contra: − Tissue ingrowth (uncovered mesh) − Repeat stent placement • Ella BD stent Siersema et al. Gastrointest Endosc 2009 Repici et al. Gastrointest Endosc 2010 (in press)
  • 19. Esophageal stents - issues • Complications/recurrent dysphagia • Stents for malignant indications • Stents for benign strictures • Stents for benign ruptures and anastomotic leaks
  • 20. Benign rupture/leak Treatment algorithm Small (<2 cm) Intermediate (>2 cm) Large (<25% of circumference) (>25% and <50-70%) (>50-70%) Stricture (-) Stricture (+) <1 cm <1 cm ?? SEALANT ENDOCLIP STENT SURGERY Siersema. Chapter 19: Esophageal perforation In: Tham T, Collins J and Soetikno R, eds. Gastrointestinal Emergencies Oxford: Blackwell Publishing Ltd 2008
  • 21. Benign rupture/leak Treatment algorithm Small (<2 cm) Intermediate (>2 cm) Large (<25% of circumference) (>25% and <50-70%) (>50-70%) ?? STENT Siersema. Chapter 19: Esophageal perforation In: Tham T, Collins J and Soetikno R, eds. Gastrointestinal Emergencies Oxford: Blackwell Publishing Ltd 2008
  • 22. Benign rupture/leak Stent choice Fully covered stents • Polyflex • Niti-S • SX-Ella • Alimaxx-E • Evolution FC • Wallflex FC Siersema et al. Gastrointest Endosc 2009
  • 23. Benign rupture/leak Stent choice Fully covered stents • Polyflex • Niti-S • SX-Ella Pro: - Incomplete sealing (?) • Alimaxx-E • Evolution FC • Wallflex FC Siersema et al. Gastrointest Endosc 2009
  • 24. Benign rupture/leak Stent choice Fully covered stents Partially covered stents • Ultraflex • Evolution PC • Wallflex PC Siersema et al. Gastrointest Endosc 2009
  • 25. Benign rupture/leak Stent choice Fully covered stents Partially covered stents • Ultraflex Pro: - More complete sealing (?) • Evolution PC - Success rate (n=52): 76% (i.t.t. 65%) • Wallflex PC Contra: - Repeat stenting (83 stents (52 pats.)) (q 3-4 wks.) - Complications (migration, tissue in-/overgrowth) Tissue overgrowth: stent-in-stent technique Siersema et al. Gastrointest Endosc 2009 van Boeckel et al. Surg Endosc (submitted) Hirdes et al. Am J Gastroenterol 2010 (in press)
  • 26. Stent-in-stent technique • Embedded stent visualized during endoscopy • Insert second, fully covered stent inside embedded stent – with similar length + diameter HV-ELLA stent – at level of tissue hyperplasia • Stent-in-stent for 10-14 days in situ • Radial force induces pressure necrosis of hyperplastic tissue Polyflex stent
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  • 32. Esophageal stents - issues • Complications/recurrent dysphagia • Stents for malignant indications • Stents for benign strictures • Stents for benign ruptures and anastomotic leaks →Future developments
  • 33. Esophageal stents - Future Malignant esophageal strictures: – (New design) covered biodegradable stents – Stents plus radiation therapy (brachytherapy) – Bridge-to-Surgery
  • 34. Esophageal stents - Future Malignant esophageal strictures: – (New design) covered biodegradable stents – Stents plus radiation therapy (brachytherapy) – Bridge-to-Surgery Benign esophageal strictures or ruptures: – (New design) covered biodegradable stents – Non-traumatic, more flexible (nitinol) stents – Stents with antifibrotic agents incorporated