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  Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 53  |  Issue : 4  |  Page : 534-537
 

Assessment of safety and efficacy of an indigenous self-expandable fully covered esophageal metal stent for palliation of esophageal cancer


1 Department of Gastroenterology, All Institute of Medical Sciences, New Delhi, India
2 Department of Gastrointestinal Surgery, All Institute of Medical Sciences, New Delhi, India

Date of Web Publication21-Apr-2017

Correspondence Address:
PK Garg
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0019-509X.204760

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 » Abstract 

BACKGROUND: Patients with unresectable esophageal cancer require palliation for dysphagia. Placement of a self-expandable metal stent (SEMS) is the procedure of choice for palliation of dysphagia. OBJECTIVE: To evaluate the safety and efficacy of an indigenous fully-covered SEMS in patients with esophageal cancer. METHODS: Eligible patients with unresectable esophageal cancer requiring palliation for dysphagia were included in the study. An indigenous fully covered SEMS of appropriate length was placed under endoscopic and fluoroscopic guidance. Outcome measures assessed were adverse events and improvement in dysphagia. RESULTS: Twenty one patients (mean age 57.71±13.14 years; 17 males) were included. After stenting, dysphagia score decreased from 3.2+0.4 to 0.35+0.74 at 4 weeks. Adverse events included retrosternal pain, respiratory distress and aspiration pneumonia in 12, 2 and 1 patients respectively. Five patients required repeat stenting due to stent migration in 4 (following radiotherapy in 3) and tumour ingrowth in 1. There was primary stent malfunction in one patient. The median survival of patients was 140 (76-199) days, which was higher in those who received radiotherapy. CONCLUSION: The stent was reasonably safe and effective to relieve dysphagia due to unresectable esophageal cancer.


Keywords: Dysphagia, esophageal cancer, metal stent


How to cite this article:
Padhan R, Nongthombam S, Venuthurimilli A, Dhingra R, Shalimar, Sahni P, Garg P. Assessment of safety and efficacy of an indigenous self-expandable fully covered esophageal metal stent for palliation of esophageal cancer. Indian J Cancer 2016;53:534-7

How to cite this URL:
Padhan R, Nongthombam S, Venuthurimilli A, Dhingra R, Shalimar, Sahni P, Garg P. Assessment of safety and efficacy of an indigenous self-expandable fully covered esophageal metal stent for palliation of esophageal cancer. Indian J Cancer [serial online] 2016 [cited 2019 Aug 24];53:534-7. Available from: http://www.indianjcancer.com/text.asp?2016/53/4/534/204760



 » Introduction Top


Esophageal cancer is an aggressive gastrointestinal (GI) malignancy with a poor prognosis. The 5-year survival rate is <20%.[1] This is mainly due to its insidious symptomatology, a late clinical presentation, and rapid progression. The majority of patients with esophageal cancer have unresectable disease at presentation and require effective palliation of their symptoms.[1] The predominant symptom of advanced esophageal cancer is dysphagia with 80–90% of all patients having some difficulty in swallowing. Relief of dysphagia is, therefore, a priority for any palliative treatment of patients suffering from esophageal cancer. In patients with inoperable esophageal cancers, palliative stenting with self-expandable metal stents (SEMSs) is effective in improving dysphagia and is also associated with improvement in the quality of life.[2],[3] However, the use of SEMS in India is limited by its high cost as most of the stents are imported. Recently, an indigenous SEMS with specifications as per international standards has been introduced in India. Our objective was to evaluate the safety and efficacy of the indigenous fully covered SEMS for relief of dysphagia in patients with inoperable esophageal cancer.


 » Methods Top


The study was conducted at the Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, from October 2013 to June 2015. The study was approved by the Institute's Ethics Committee. Informed written consent was given by all patients. The study was registered at www.ctri.nic.in (CTRI/2013/04/003603).

Patients

Consecutive patients with esophageal cancer and dysphagia satisfying one of the following inclusion criteria were included (1) locally advanced unresectable esophageal cancer as defined by involvement of tracheobronchial tree, aorta, or pulmonary vasculature, (2) metastatic disease, (3) poor performance status (The Eastern Cooperative Oncology group performance status 3 or 4).[4] Patients who did not give written consent or had prior SEMS placement were excluded from the study.

Evaluation of patients

All patients underwent a thorough clinical examination, upper GI endoscopy and biopsy to confirm the diagnosis. Contrast enhanced computed tomography (chest and abdomen) was used to assess local tumor infiltration and metastasis. Complications due to cancer such as tracheoesophageal fistula and aspiration pneumonia were noted. Palliative radiotherapy was offered to patients after stenting as per their willingness and assessment by a radiotherapist.

Assessment of dysphagia

The following dysphagia scoring system (Mellow and Pinkas)[5] was used before and after the placement of the stent to assess the response:

  • 0: Able to eat normal diet/no dysphagia
  • 1: Able to swallow some solid foods
  • 2: Able to swallow only semi-solid foods
  • 3: Able to swallow liquids only
  • 4: Unable to swallow anything/total dysphagia.


Characteristics of the indigenous self-expandable metal stent

SEMS manufactured indigenously (Mitra Industries Pvt. Ltd., Faridabad, India) was used in the study. The stent is made up of nitinol and is fully covered with a medical grade polymer. The delivery catheter is made up of polytetrafluoroethylene and stainless steel tubes. The markings are with gold wires. There is a nylon thread (lasso) at the proximal end.

Physical inspection of a bare stent and stent deployment in vitro were satisfactory. The data of its physical characteristics such as radial force have been shown to be comparable with other imported stents available in India.

Procedure for stent placement

An upper GI endoscope (Olympus Inc., India) was used to ascertain the site and size of the tumor. The length of the stricture was assessed on endoscopy if scope was passable across the stricture. Otherwise, contrast was injected though the esophageal lumen across the stricture using a cannula, and the length was assessed by radiography. A guidewire was passed across the stricture under fluoroscopic guidance. A marker was placed 2 cm proximal to the upper end of the stricture by injecting contrast into the submucosa, and an external marker was placed. An SEMS of appropriate length was placed over the guidewire and deployed under fluoroscopic guidance across the stricture with at least 2 cm of stent above the upper margin and 2 cm below the lower margin of the stricture. The final position of the stent was documented on a plain X-ray.

Postprocedure care

Patients were observed for at least 8 h after the procedure in the hospital. A chest X-ray was done routinely to check the stent position and to rule out any perforation. Oral fluids were allowed if there were no complications such as pain or vomiting. The patients were discharged with advice regarding diet, antireflux measures, and follow-up visits.

Assessment of complications

Both stent and procedure-related complications were assessed during and after the procedure for the next 30-days. Stent-related adverse events included primary stent malfunction, i.e., failure to open up fully, stent migration, stent fracture, and stent blockage. Procedure-related adverse events included upper GI bleeding, esophageal perforation, respiratory distress, chest pain, aspiration pneumonia, vomiting, gastroesophageal reflux, and hiccoughs.

Management of complications

All complications were assessed and treated as per the standard guidelines. A repeat endoscopy was performed in patients with recurrent dysphagia, GI bleeding, and persistent vomiting to assess the cause. Another SEMS was placed in the case of SEMS blockage due to tumor ingrowth or migration of the previous SEMS. In case of any major complications, patients were admitted and provided free treatment in the hospital as per the standard management protocol.

Follow-up

Patients were followed up at 1, 4, 12, 24, and 52 weeks or as and when required and were assessed for dysphagia scores and complications. In case, a patient was unable to visit; telephonic interview was done.

Outcome measure

Development of adverse events and relief in dysphagia was the outcome measures.

Statistical analysis

Normally distributed continuous variables are expressed as mean (standard deviation [SD]), and those with skewed distribution are expressed as median (range). Dysphagia scores before and after stenting were compared using paired Student's t-test. P<0.05 was taken as statistically significant. Survival was assessed using Kaplan–Meier graph and log-rank test was used for comparison between different modalities of treatment.


 » Results Top


A total of 21 patients were included and underwent esophageal SEMS placement. Their mean age (±SD) was 57.71 ± 13.14 years, and 17 (80.1%) patients were male. Three (1.4%) patients had tracheoesophageal fistula, and all patients had unresectable disease. The mean follow-up was 4.5 months.

Improvement in dysphagia

The mean (±SD) dysphagia score at baseline was 3.2 ± 0.43. Following SEMS placement, improvement in dysphagia score at 1, 4, 12, and 24 weeks were 0.28 ± 0.64, 0.35 ± 0.74, 0.31 ± 0.70, and 0.42 ± 1.13, respectively, the reduction being statistically significant [Table 1]. The mean duration of stent patency was 4 months. No patient survived at 1 year.
Table 1: Dysphagia scores following stenting

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Complications following stenting

Five patients (23.9%) developed recurrent dysphagia after a mean duration of 58 days. The cause of dysphagia was stent migration in four and tumor ingrowth in one patient, which occurred after 6 months. Stent migration occurred after 34, 28, 45, and 5 days in four patients, respectively [Table 2]. All these patients were successfully managed with repeat SEMS placement. Among the four patients (19%) with stent migration, the stent migrated following radiation therapy in three patients that occurred after mean interval of 36 days following SEMS placement. In addition, other complications in the form of respiratory distress developed in 2 (9%) patients, which improved with conservative treatment. None of these patients had pneumothorax. One patient developed pneumonia possibly due to aspiration after stenting. The patient with aspiration pneumonia later developed sepsis and succumbed. The above patient had extensive locally advanced disease, metastasis, and poor nutritional status, which together contributed to his demise. Minor complications included chest pain in 12 (57.1%) patients, gastroesophageal reflux and hiccoughs in 5 (23.80%) patients and 1 (4.7%) patient, respectively. None of the patients had bleeding or esophageal perforation.
Table 2: Complications related to esophageal stenting (in order of frequency)

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Survival

The overall median survival was 140 (76–199) days. All patients died due to general debility and metastatic disease and not as a direct result of stenting. The difference in survival between 14 patients who received radiation therapy and seven patients who did not was statistically significant (150 days vs. 90 days; P = 0.01) [Figure 1].
Figure 1: Survival curves in esophageal cancer patients managed with self-expandable metal stent alone and those with combined self-expandable metal stent and radiotherapy. Median survival in patients without radiotherapy: 90 days (range 9–140) and those in radiotherapy group: 150 days (range 54–232)

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 » Discussion Top


Esophageal cancer is a common GI malignancy. Unfortunately, the tumor is unresectable at presentation in most patients. Dysphagia is the major symptom in them that requires palliation. The placement of an SEMS is the method of choice to relieve dysphagia. Almost all SEMS that are available in India are imported and are thus quite expensive. In this pilot study, we assessed the safety and efficacy of an indigenous fully covered esophageal SEMS to relieve malignant dysphagia in patients with advanced esophageal cancer. We found that there was a significant improvement in dysphagia score. The relief in dysphagia was persistent. Only one patient developed recurrent dysphagia due to tumor ingrowth. In rest of the patients, the stents remained patent until either the death of the patients or the last available follow-up. The stent patency rates have been reported to be 93.5, 78.1, and 67.0% at 30, 90, and 180 days in one study which was comparable to ours.[6] Four patients developed stent migration, which occurred mainly due to radiation therapy. Radiotherapy is a known risk for stent migration, which in fact suggests good tumor response to radiotherapy.[7]

There were no major procedure-related complications. However, two patients developed respiratory distress following the procedure, which was managed conservatively. Chest pain was the most common complaint in about half of the patients, which is a known problem in a significant number of patients.[8] The cause of it is not well understood. Pain relief often requires opioid analgesics.[8] One patient developed aspiration pneumonia and succumbed to his illness owing to poor general condition, sepsis, and underlying advanced malignancy after 45 days of stenting.

The present study also showed that the overall median survival was short (140 days). However, the survival was better in patients who underwent radiation therapy after SEMS placement as compared with those who did not. This may not reflect the true picture as those patients who did not receive radiation therapy were sicker with poorer performance status and hence bound to have a shorter survival. In a randomized study from our institution, dysphagia relief was longer (7 vs. 3 months, P = 0.002) and the median survival was significantly higher (180 vs. 120 days, P = 0.009) in radiotherapy versus nonradiotherapy group after the placement of SEMS in patients with esophageal cancer.[9] Another study has also shown longer survival with multimodality treatment after SEMS placement in patients with unresectable esophageal cancer.[10] A prospective randomized trial is in progress to study the effect of additional radiotherapy after SEMS placement in patients with esophageal cancer.[11]

Many types of SEMS are available with different material, covering, design, and radial force. An ideal stent would be one with minimal risk of ingrowth, migration, pain, and aspiration. In a study comparing seven generations of SEMS in 645 patients, stenting was technically successful in 99.4% with a clinical success rate of 95.5%.[12] Complications occurred in 40.3% necessitating removal of 68 stents (11%). Stainless steel stents and radiation therapy before stent placement were significantly associated with severe chest pain. The factors associated with stent migration were flared stent ends, stricture length <6 cm, and a stent diameter <18 mm. Stent covering with polytetrafluoroethylene membrane was associated with lesser tumor ingrowth than polyurethane membranes.[12] Hopefully, with further improvements in stent design and material, the complications associated with SEMS may be minimized.


 » Conclusion Top


In summary, the indigenous SEMS was reasonably safe and provided adequate palliation of dysphagia in patients with inoperable esophageal cancer.

Financial support and sponsorship

Mitra Industries Pvt. Ltd. (Faridabad, India) provided stents for the study. The company had no role in planning, conduct, and interpretation of the study, and the decision to publish the results of the study.

Conflicts of interest

There are no conflicts of interest.

 
 » References Top

1.
Sreedharan A, Harris K, Crellin A, Forman D, Everett SM. Interventions for dysphagia in esophageal cancer. Cochrane Database Syst Rev 2009;(4):CD005048.  Back to cited text no. 1
    
2.
Madhusudhan C, Saluja SS, Pal S, et al. Palliative stenting for relief of dysphagia in patients with inoperable esophageal cancer: Impact on quality of life. Dis Esoph 2009;22:331-6.   Back to cited text no. 2
    
3.
Bown SG. Palliation of malignant dysphagia: Surgery, radiotherapy, laser, intubation alone or in combination? Gut 1991;32:841-4.  Back to cited text no. 3
    
4.
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649–55.  Back to cited text no. 4
    
5.
Mellow MH, Pinkas H. Endoscopic laser therapy for malignancies affecting the esophagus and gastroesophageal junction: Analysis of technical and functional efficacy. Arch Intern Med1995;145:1443-6.  Back to cited text no. 5
    
6.
Im JP, Kang JM, Kim SG, Kim JS, Jung HC, Song IS. Clinical outcomes and patency of self-expanding metal stents in patients with malignant upper gastrointestinal obstruction. Dig Dis Sci 2008;53:938-45.  Back to cited text no. 6
    
7.
Park JJ, Lee YC, Kim BK, et al. Long-term clinical outcomes of self-expanding metal stents for treatment of malignant gastroesophageal junction obstructions and prognostic factors for stent patency: Effects of anticancer treatments. Dig Liver Dis 2010;42:436-40.  Back to cited text no. 7
    
8.
Golder M, Tekkis PP, Kennedy C. Chest pain following oesophageal stenting for malignant dysphagia. ClinRadiol 2001;56:202-5.  Back to cited text no. 8
    
9.
Javed A, Pal S, Dash NR, et al. Palliative stenting with or without radiotherapy for inoperable esophageal carcinoma: A randomized trial. J Gastrointest Cancer 2012;43:63-9.  Back to cited text no. 9
    
10.
Rueth NM, Shaw D, D'Cunha J, Cho C, Maddaus MA, Andrade RS. Esophageal stenting and radiotherapy: A multimodal approach for the palliation of symptomatic malignant dysphagia. Ann Surg Oncol 2012;19:4223-8.  Back to cited text no. 10
    
11.
Adamson D, Blazeby J, Nelson A, et al. Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial. Trials 2014;15:402.   Back to cited text no. 11
    
12.
Na HK, Song HY, Kim JH, et al. How to design the optimal self-expandable oesophageal metallic stents: 22 years of experience in 645 patients with malignant strictures. Eur Radiol 2013;23:786-96.  Back to cited text no. 12
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2]



 

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