Esophageal Stenting: Role in strictures, leaks, fistulae, and malignancy

Esophageal Stenting: Role in strictures, leaks, fistulae, and malignancy Jasmine L. Huang, MD General Thoracic Surgery St. Joseph s s Hospital and Medical Center Phoenix, AZ

Jasmine Huang, MD I have no financial relationship with any manufacturer of any commercial product and/or provider of commercial services discussed in the CME activity. I do not intend to discuss an unapproved/investigative use of a commercial product or device in my presentation. The planning committee for this event has no relevant financial relationships with commercial interest to disclose.

Outline The Ideal Stent Indications for stent placement Stenting for Malignancy Strictures Leak TEF Troubleshooting Future directions Recommendations

The Ideal Stent Does not leak Seals leaks Easy to retrieve Is not painful Does not cause reflux Allows a person to eat Does not cause stricture formation Compresses to a smaller size without infolding Easy to see under fluoroscopy Has just enough tissue ingrowth Has the ability to articulate with more stents Promotes healing Collagen matrix Growth factors Is easy to remove

Types of Stents Rigid plastic tubes Self-expanding expanding metals stents (SEMS) Uncovered Covered (csems( csems) Self-expanding expanding plastic stents (SEPS) Biodegradable

SEPS Polyflex (Polyethylene/Silicone) -Largest delivery system (13 mm)

SEMS Wallstents Z stents Gianturco Z (Stainless Steel/Polyurethane) Niti-S (Nitinol/Polyurethane) Esophacoil Alimaxx-E (Nitinol/Silicone) Ultraflex (Nitinol/Polyurethane) Wallflex (Nitinol/Polyurethane)

How to Stent 1. Endoscopy 2. Guidewire 3. Mark perforation as you withdraw 4. Remove scope 5. Place stent 6. Deploy

Indications for Stenting Dysphagia (esophageal/gastric cancer) Tracheo-esophageal fistula (TEF) Local recurrence Esophagectomy conduit Gastrectomy reconstruction Malignant

Indications for Stents Benign Perforation/leaks Anastomotic Post dilatation leak Boerhaave s syndrome Stricture Complex Caustic ingestion Radiation injury Anastomotic stricture Severe peptic injury

Stent Comparisons SEMS Advantages Lower migration rates Low profile delivery Disadvantages Difficult to remove Tumor/tissue ingrowth SEPS Advantages Removable Less tumor/tissue ingrowth Disadvantages High migration rates Thick, rigid deployment catheter

Procedure Related Complications Acute Perforation Aspiration pneumonia Fever Hemorrhage Severe pain Delayed Hemorrhage Fistula formation Stent migration Tumor/tissue ingrowth Food obstruction

SEPS > SEMS Location Risk Factors Stent Migration Distal and proximal > mid-esophageal Indication Peptic stricture > anastomotic > fistulas/leaks > postradiation strictures

In the setting of malignancy Why stents are useful Good palliation Dysphagia/wt loss most common presenting symptom Unresectable in 50% of pts at presentation Overall 5 yr survival < 10% Median survival in unresectable disease 3-6 mo Management of treatment complications Perforation post dilatation Anastomotic leaks/strictures Postradiation strictures Bridge to definitive therapy Stent prior to neoadjuvant therapy

ACG Practice Guidelines - Malignancy Malignant strictures and fistulas SEMS are superior to rigid plastic prosthesis in management of unresectable obstructive esophageal cancers SEMS > SEPS for malignancy (fewer complications) SEMS is treatment of choice for malignant fistula Sharma P and Kozarek R. Role of esophageal stents in benign and malignant diseases. Am J Gastroenterol 2010; 105: 258-273.

Use of stenting in strictures

Type of stricture Simple Focal Straight Diameter that usually allows passage of normal diameter endoscope Usually can be treated with bougie or balloon dilation Common etiologies: peptic injury, Schatzki s ring/web

Type of stricture Complex Long, > 2 cm Tortuous Narrow diameter (< adult scope) Common causes: caustic ingestion, radiation injury, anastomotic stricture, severe peptic injury High recurrence rate with dilation, refractory to dilation

Results SEMS Approximately 50% recurrence rate Post radiation strictures more successful than peptic, anastomotic,, or achalasia Shorter strictures lower risk of recurring Tissue ingrowth noted SEPS Development of fully covered stents Migration rates higher Less ingrowth 40% long term success rate Siersema PD. Stenting for benign esophageal strictures.. Endoscopy 2009; 41: 363-73

ACG Practice Guidelines Benign Strictures SEMS Partially covered are not recommended or FDA approved for benign esophageal conditions SEPS Cannot be routinely recommended but strength of recommendation is weak Retrievable SEPS/SEMS/Biodegradable stents Encouraging results but recommend further studies

Management of Esophageal Leaks Gastric bypass Anastomotic leaks Boerhaave perforation Iatrogenic perforation Spontaneous cervical perforation

Esophageal Stenting for Anastomotic Leaks Roy-Choudry, 2001, n=14, healing 13/14 (93%)EG Fernandez, 2010, n=4, healing 3/ 4(75%)EJ Dai, 2010, n=30, healing 27/30 (90%) EJ Schweigert, 2011, healing 9/12 (85%) EG Freeman, 2007, n=5, healing 4/5(80%) EG Blackmon, 2010 n=13, healing 12/13 (94%) EJ +EG Roy-Choudry SH, et al. AJR January 2001, 176, 161-3. Fernandez A. Rev Esp Enferm Dig. 2010 Dec;102(12):704-10. Dai Y, Chopra S, KneifS, HunerbeinM. J ThoracCardiovascSurg. 2010 Dec 15 Schweigert M et al. Interact Cardiovasc Thorac Surg. 2011 Feb;12(2):147-51. Freeman R, AsciotiA, WoznaikTC. JTCVS. 2007 Feb;133(2):333-8. Blackmon SH. Et al Ann Thorac Surg. 2010 Mar;89(3):931-6; discussion 936-7.

Esophageal Stenting for Leaks The advantage of esophageal stenting with leaks and fistulas is the salvage of an optimal conduit - saving the esophagus is key Blackmon SH, Santora R, Schwarz P, Barroso A, Dunkin BJ. Utility of removable esophageal covered self-expanding metal stents for leak and fistula management. Annals of Thoracic Surgery, 2010;89:931-7.

Esophageal Stenting for Leaks Still have to drain infection HAVE to see the leak Still have to decorticate lung Can heal leaks as large as 5cm long Know when to stop stenting Stent-guided re-epithelialization may lessen strictures once healed Hybrid procedures still performed Muscle flaps when in chest augment healing

Esophageal Stenting for Anastomotic Leaks Make sure the conduit is viable Must sleeve the entire conduit if large gastric conduit is made May lessen stricture after leak heals? Scaffold for re-epithelialization

Esophageal Stenting for Iatrogenic Perforation Freeman, 2007 n=17 healed 16/17 (94%) van Heel, 2010 n=19 healed 18/19 Many small case reports in the literature Freeman RK, Van WoerkomJM, AsciotiAJ. Ann ThoracSurg. 2007 Jun;83(6):2003-7.Van Heel et al. Am J Gastroenterol. 2010 Jul;105(7):1515-20.

Esophageal Stenting for Iatrogenic Perforation Majority are from dilations The earlier you stent, the better the outcome Many can be observed If the leak does not heal, think cancer

ACG Practice Guidelines - Leak SEMS and SEPS can be considered in treatment of perforation, leaks, and fistulas Strength of recommendation is weak

Acquired TEF Benign Post intubation Inflammatory Wegener s s granulomatosis Tb, syphilis, actinomycosis, histoplasmosis, aspergillus, candida Trauma Blunt Compression Rupture Penetrating Often assoc with lethal great vessel injuries Burns and caustic injuries Foreign bodies Impacted disc battery Fish bones Malignant Esophageal cancer Lung cancer Tracheal cancer Laryngeal cancer Lymphoma

Malignant Acquired TEF Management Airway/esophageal stents for palliation Prevent ongoing pulmonary soilage Restore swallowing Staged surgical repair after curative therapy (ie lymphoma)

Esophageal Stents for TEF Only the successes are reported Cook TA. DehnTC. Use of covered expandable metal stents in the treatment of oesophagealcarcinoma and tracheo-oesophagealfistula. British Journal of Surgery. 83(10):1417-8, 1996 Oct. EllulJP. Morgan R. Gold D. DussekJ. Mason RC. Adam A. Parallel self-expanding covered metal stents in the trachea and oesophagus for the palliation of complex high tracheooesophagealfistula. British Journal of Surgery. 83(12):1767-8, 1996 Dec. HramiecJE. O'Shea MA. Quinlan RM. Expandable metallic esophageal stents in benign disease: a cause for concern. Surgical Laparoscopy & Endoscopy. 8(1):40-3, 1998 Feb. Zaki HS. Studer SP. Kharchaf M. Myers EN. Prosthetic obturation of tracheoesophageal fistula. Laryngoscope. 111(2):359-60, 2001 Feb.

Troubleshooting

Problem Solving Migration of the Stent Summary of migration issues: Migration is more pronounced when covering the UES Migration also happens more frequently at the lower esophagus Stricture vs. leak

Problem Solving Migration of the Stent Umbilical tape: One end out R nostril The other out L nostril Bridling of the stent: Solutions #1: Bridging the stents together Solution #2: Suture fixation

Migration Esophageal pexy Used for UES stents carotid track suture passer must follow to avoid arterial injury trachea Stent in esophagus pexy as it appears after endoscopy

Pexy of Esophageal Stent Using Gore-Tex Pledget

Esophageal Stents Unique Problems Stent folding Solution #1: balloon dilation Solution #2: swallow test for efficacymay not have to do anything Solution #3: replace with csems that will not fold

Pain Esophageal Stents Unique Problems Appears to be worse in benign disease than malignant Another reason why removable stents may be better even in malignant cases Solution: pain medication versus baclofen versus removal

Esophageal Stents Unique Problems Granulation Tissue and In-growth Removal may be difficult (especially with the metal stents, thus do not place them for benign disease) Solution: mechanical debridement or freezing may also be an option

Esophageal Stents Unique Problems Granulation Tissue and In-growth Solutions: endoscopy around the stent first, rigid esophagoscopy

GERD Esophageal Stents Unique Problems Solution #1: cut a v in the bottom of the polyflex stent on opposite sides to allow in-folding at the bottom and prevent reflux Solution #2: Antireflux/Heimlich valve has been built into the stent Solution #3: G Tube or NGT to decompress (beware of suctioning the stent too much!)

What is the future of esophageal stenting? Collagen matrix on the outside of the stent (Takimoto et al.) Collagen sponge to promote healing (Yamamoto et al.) Better retrieval devices (Yoon et al.) Biodegradable stents (Saito et al.) Brachytherapy seeds loaded within the stents (Guo et al.)

Biodegradable Stents Biodegradable poly-l-lactic acid (PLLA) esophageal stents (n=2) with benign esophageal stenosis after endoscopic submucosal dissection (ESD). After balloon dilatation, the PLLA esophageal stents were endoscopically placed. Due to the biodegradable features of this stent, longer term studies are necessary to investigate the relationship between the expected disappearance of the stent and the patency of the stricture. Saito Y. et al. Digestive Diseases & Sciences. 53(2):330-3, 2008 Feb.

Brachytherapy Stents Randomized, case-controlled trial of self-expandable esophageal stent loaded with I 125 seeds for intraluminal brachytherapy versus the response to treatment with a conventional csems in patients with advanced esophageal cancer. Stent Type: n dysphagia Hemorrhage Survival improvement Radiation stent 27 R>C, (p<.05) R>C, (p<.001) Control stent 26 Both 16(30%) Guo JH. Teng GJ. Zhu GY. He SC. Fang W. Deng G. Li GZ. Radiology. 247(2):574-81, 2008 May.

Brachytherapy Stents In patients with advanced esophageal cancer, treatment with an esophageal stent loaded with I 125 seeds has a slightly longer relief of dysphagia and extended survival compared to a conventional stent. Guo JH. Teng GJ. Zhu GY. He SC. Fang W. Deng G. Li GZ. Radiology. 247(2):574-81, 2008 May.

What other options are being explored for esophageal fistulas?

Role in leaks Recommendations Choice of treatment is dependent on cause and location of injury, underlying esophageal disease, interval of time to diagnosis and treatment Treatment is still controversial but stenting is increasingly being utilized Primary repair is still preferable when able Role for stenting seen in: Thoracic-abdominal abdominal perforations which are within a healthy esophagus and are contained Inoperable malignancy High risk surgical candidate Post-surgical surgical anastomotic leaks Studies are retrospective

Role in malignancy Recommendations Palliation Management of treatment complications Perforation post dilatation Anastomotic leaks/strictures Postradiation strictures Bridge to definitive therapy Stent prior to neoadjuvant therapy

Role in benign stricture Recommendations Refractory strictures Consider location and etiology of stricture when deciding on type of stent Stent placed for 4 weeks up to 4 months depending on the type of stent used Surveillance endoscopies at least every 4 weeks are recommended

Esophageal Stenting The Future Vac sponge? Biodegradable stents Endoscopic suturing devices Randomized trials comparing available treatment options CernaM et al. Covered Biodegradable Stent: New Therapeutic Option for the Management of Esophageal Perforation or AnastomoticLeak. CardiovascInterventRadiol. 2011 Jan 7.