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A simplified technique of esophageal self-expandable metallic stent placement without fluoroscopic and endoscopic guidance for treating esophageal carcinoma.

INTRODUCTION

Esophageal cancer is the eighth most common cancer among all cancers worldwide, with a substantially increasing prevalence. More than 50% of patients present with either locally advanced disease or metastasis at the time of diagnosis (1). Self-expandable metallic stent (SEMS) placement is imperative in the amelioration of dysphagia, thereby enhancing the quality of life of patients (1). Furthermore, the use of SEMSs is explicitly associated with relatively lower morbidity and mortality rates than the use of plastic stents (2).

Earlier studies had evinced that SEMS placement is performed under fluoroscopic or endoscopic guidance. However, the limited accessibility to fluoroscopy and the hazard of radiation exposure are established as the two main pitfalls pertaining to fluoroscopic guidance (3). Although endoscopic guidance during SEMS placement is an effort to overcome these limitations, it had a constraint of affecting patient compliance during the procedure, thereby demanding the use of a nasogastroscope or an ultra-thin scope (4). The other disadvantage is that it requires two experts to perform the procedure. The first expert is needed to place the SEMS, and the second expert performs endoscopy and assists the first expert to place the stent under endoscopic guidance. Therefore, we developed a simplified technique of SEMS placement without fluoroscopic guidance and with limited endoscopic guidance i.e., endoscopy was used only to assess the extent of the carcinoma of esophagus and not during the stent deployment. In this study, we compared the safety and efficacy of the simplified technique of esophageal SEMS placement (without fluoroscopic guidance) with that of the conventional method (with fluoroscopic guidance) in patients with advanced esophageal carcinoma.

MATERIALS AND METHODS

This retrospective study was conducted with prior institutional ethics committee approval. The endoscopy registry and inpatient case records of patients who were diagnosed of advanced esophageal carcinoma and who underwent SEMS placement between January 2012 and September 2016 were analyzed. Telephone calls were made to collect data whenever necessary. During this study period, all patients in who underwent SEMS placement were divided into two groups on depending on whether fluoroscopic guidance was performed. Patients who were aged over 18 years and with histopathologically proven carcinoma of the esophagus not amenable to curative treatment were included. Patients with tumors located 2-3 cm close to the cricopharyngeus muscle and who required the placement of more than one stent or telescopic SEMS were excluded. Pre-procedural informed consent was obtained from the patients.

Data pertaining to the early and late complications of stent placement were obtained from the case records. Complications were defined as early and late based on those occurring before SEMS placement and 7 days after SEMS placement (5).

Dysphagia scoring was done before and after the procedure:

Grade 0: no dysphagia, able to tolerate normal food

Grade 1: able to swallow most foods

Grade 2: able to swallow a soft diet

Grade 3: able to swallow liquid only

Grade 4: unable to swallow saliva

Technical success was defined as the ability to accurately place and expand the stent at the desired level in the first attempt.

Technique

Conventional technique (with fluoroscopic guidance)-group A

Under conscious sedation with intravenous midazolam and fentanyl, esophagogastroduodenoscopy (EGD) was performed to compute the proximal and distal extents of the lesion. Whenever dilatation was needed, a guide wire (0.035 inch with a soft tip) was placed across carcinoma of esophagus and it was dilated with serial Savary-Gilliard bougies. The proximal and distal extents of the tumor were marked under fluoroscopic guidance either by an external radiopaque marker or by the submucosal injection of a contrast material serving as an internal marker. The guide wire was lodged in the antrum of the stomach, further after withdrawal of the endoscope the SEMS assembly would be threaded over the guide wire. The SEMS was placed by the distal release technique. During and after placement, the proper positioning of the SEMS was firmly established fluoroscopically and the expansion of the SEMS was endoscopically confirmed on the next day of the procedure.

Simplified technique (without fluoroscopic or endoscopic guidance)-group B

With conscious sedation, EGD was performed to determine the anatomical level of the esophagogastric junction and proximal and distal extents of the lesion as well as to locate the cricopharynx. The proximal extent of the carcinoma of esopghagus (Figure 1) was noted in centimeters from the incisor teeth (X). The proximal end of the stent was planned to be placed at least 2 cm above this level (X-2). Factor (X-2) is to account for the expanded portion of the SEMS. This level (X-2) was noted over the graduation visualized in the inner sheath of the stent assembly seen through the transparent outer sheath (Figure 2). The stent assembly was then threaded over the guide wire till the (X-2) mark on the stent assembly reached the incisor teeth (Figure 3). At this point, the marking on the stent assembly (X-2) at the incisor teeth was the same as the distance at which the proximal extent of the stent was planned to be placed. After confirming this, stent placement was slowly performing using the distal release technique (Figure 4). Post-procedure endoscopy was performed to affirm the position of the proximal end of SEMS (Figure 5a,b). After SEMS placement, the patients were placed in the semi recumbent position and kept nil orally and the infusion of clear oral fluids was started 6 h later. The following day, a soft semi-solid diet was initiated according to the tolerance of the patient.

Statistical analysis

Statistical analysis was performed using (IBM Inc.; SPSS Statistics for Windows, Version 24.0. Armonk, NY, ABD) The independent samples t-test and paired t-test were used to compare patients between the two groups and within the groups, respectively. The Mann-Whitney U test was performed for quantitative variables. p<0.05 was considered as the level of significance.

RESULTS

A total of 62 patients were placed on stents for the palliation for esophageal carcinoma, with 46 patients in group A and 16 in group B. The demographic findings and characteristics of the patients are shown in Table 1. The mean age of the patients was 57.7[+ or -]12.5 y. There was no statistically significant difference in the age of the patients in the two groups (p=0.535). Of the 62 patients included in the study, 46 were male and 16 were female. In groups A and B, the most common site of the tumor was mid-esophagus, as observed in about 65.22% and 68.75% of the patients, respectively. The existence of tracheoesophageal fistula was observed in about 16 patients. The extent of the lesion was about 8.4[+ or -]2.8 cm and 7.5[+ or -]2.1 cm in groups A and B, respectively, and was almost homogenous in both the groups (p=0.274). Considering the type of carcinoma, squamous cell carcinoma was the most common histopathological type observed in both study groups. Dysphagia was evaluated before and after the procedure with the dysphagia score. The dysphagia score was not significantly different between the groups (Table 2). There was a statistically significant difference within the groups (p= 0.001 in both groups) before and after SEMS placement, suggesting a greater degree of improvement in dysphagia in both groups. The mean duration of the procedure was 15 min 4 s in group A and 2 min 53 s in group B; this difference was statistically significant (p=0.001), suggesting the superiority of the simplified technique over the conventional technique. The technical success rate achieved in groups A and B were 97.82% and 100%, respectively. The conventional technique needed two experts for SEMS placement, whereas the simplified technique needed only one expert. With regard to immediate complications, 26.08% and 6.25% of the patients in groups A and B, respectively, underwent SEMS repositioning due to distal migration. In group A, two patients developed aspiration and one patient underwent stent removal due to lodging of the SEMS in the cricopharynx during repositioning. Both complications were not seen in group B. Other immediate complications such as perforation, delivery system entrapment, and procedure-related mortality were not present in both groups. Early complications ([less than or equal to]7 days) and late complications (>7 days) observed in the study groups were similar, with no statistically significant difference between them (Table 3). The patients were followed up at the end of one week and every month thereafter. Four patients in group A and one patient in group B were lost to follow-up.

DISCUSSION

Esophageal SEMS placement is extremely efficacious in the palliation of dysphagia due to carcinoma of esophagus (6). SEMS placement has advantages of being technically compliant and brings about the immediate relief of symptoms, resulting in it becoming the treatment of choice in patients with unresectable esophageal carcinoma,, including those complicated by fistulas (7). SEMS is slightly better than rigid plastic stents in the palliation of dysphagia (8), thereby significantly improving the quality of life of patients (9,10).

SEMS placement with fluoroscopic guidance has the disadvantage of the non-feasibility of using the fluoroscopic system in hospitals with limited settings in developing countries (11, 12). Occasionally, it also causes problems such as the migration of an external marker on movement, dissolution of the contrast agent used as an internal marker, and more importantly, hazardous radiation exposure. To overcome these issues, another technique is sought that necessitates the use of endoscopy alone for SEMS placement and its safety and efficacy is comparable to fluoroscopic guidance (2,13-20). There are few studies stating that the individual use of endoscopy is not feasible in patients with upper esophageal carcinoma and those with tight strictures. It also inconveniences patients due to insertion of an endoscope and the stent assembly, thereby requiring the use of ultra-thin or slim endoscopy (3,12). Considering this, we developed a simplified technique that could be safely performed in settings where fluoroscopic guidance and ultra-thin endoscopy are lacking. This technique is applicable only for stents that have external ruler markings used for measuring and judging stent placement.

In our simplified technique group, fully covered Niti-S[TM] Esophageal stent(outer diameter, 18 mm and length, 15 cm;Taewoong Medical Co.) was placed in 15 patients, and a fully covered Ottomed[TM] Bravo esophageal stent (outer diameter, 18 mm and length, 14 cm; Mitra Medical Services) was placed in 1 patient. Stents with outer diameters of 18 and 22 mm and lengths of 10 to 16 cm that were either partially or fully covered such as NITI-S, Ultraflex, or Endotechnik, based on the availability, were used in the conventional group in our study.

This study compared stent placement with or without fluoroscopic guidance in a single institution and used patients of similar demographics and characteristics. Both groups exhibited a comparable statistical significant improvement in dysphagia. Immediate, early, and late complications were homogenous between the groups, revealing that both techniques are equally safe.

The main advantage of the simplified technique is the reduction in procedure duration compared with that in the conventional method (2 min 53 s vs. 15 min 4 s). This study also shows that the simplified technique is highly efficacious in terms of its technical success rate (100%). The other advantages that increase the value of the simplified technique are as follows: technical ease, cost-effectiveness, and no hazardous radiation exposure; therefore, this technique can be used as a day-care procedure.

The additional advantage is that it requires only one expert to advance the stent assembly, thereby minimizing manpower; the conventional technique requires two experts: one for fixing the markers and operating the fluoroscope and the other for advancing the stent assembly. In the method used for stent placement under only endoscopic guidance, two experts are needed: one to handle the endoscope and the other to place the stent. Through-the-scope stents are also available (Tae Woong Medical); they serve the purpose of no radiation use and single operator delivery. Table 4 shows a comparison between various techniques of esophageal SEMS placement.

Some limitations of this study are as follows: retrospective nature of the study and smaller sample size in the simplified technique group. Further prospective studies in a larger population would add value in terms of the safety and efficacy of the simplified technique of SEMS placement. Stents in the simplified technique are all fully covered, whereas those in the conventional technique have various stent diameters and lengths and are also covered and uncovered; thus, a head-to-head comparison and outcomes measures cannot be made with surety.

After reviewing the literature, we found that there were no data available till date regarding SEMS placement using the simplified technique. We invented this new method of SEMS placement, which is simple, safe, effective, precise, requires minimal manpower, is less time-consuming, and without radiation exposure. Hence, we propose that this simplified method would have a promising role in SEMS placement in the future after more comprehensive evaluations in a larger series.

Ethics Committee Approval: Ethics committee approval was received for this study from institutional ethics committee of Madras Medical College (Decision Date: 02.08.2016/Decision No: 05082016)

Informed Consent: Written informed consent was obtained from patients who participated in this study.

Peer-review: Externally peer-reviewed.

Author contributions: Concept - R.K.; Design - R.K., S.R., P.T.; Supervision - R.K., P.T., M.A.; Resource - R.K., P.K., K.M.; Materials - R.K., P.K., K.M.; Data Collection and/or Processing - R.K., S.R.; Analysis and/or Interpretation - R.K., S.R., P.K.; Literature Search - R.K., R.S., K.M.; Writing - R.K., R.S.; Critical Reviews - P.T., M.A., P.K.

Acknowledgements: The authors sincerely thank all patients for their participation in this study, the nursing staff of Institute of Medical Gastroenterology of Madras Medical College and Rajiv Gandhi Government General Hospital for their support and Dr. Breetha Sabarinathan and Dr. Amudhan Aravind towards preparing this manuscript.

Conflict of Interest: No conflict of interest was declared by the authors.

Financial Disclosure: The authors declared that this study has received no financial support.

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Ratnakar Kini, Sabarinathan Ramanathan, Pugazhendhi Thangavel, Premkumar Karunakaran, Kani Shaik Mohamed, Murali Ananthavadivelu

Department of Medical Gastroenterology, Madras Medical College and Rajiv Gandhi Government General Hospital, Tamil Nadu, India

Cite this article as: Kini R, Ramanathan S, Thangavel P, Karunakaran P, Mohamed KS, Ananthavadivelu M. A simplified technique of esophageal self-expandable metallic stent placement without fluoroscopic and endoscopic guidance for treating esophageal carcinoma. Turk J Gastroenterol 2018; 29: 82-8.

ORCID IDs of the authors: R.K.0000-0002-0421-5960; S.R. 0000-0002-6292-7341; P.T. 0000-0003-3562-0130; P.K. 0000-0002-7711-9478; K.M. 0000-0001-9732-3612; M.A. 0000-0002-1499-8911

Address for Correspondence: Ratnakar Kini E-mail: gastrokini@gmail.com

Received: February 22, 2017 Accepted: September 11, 2017

DOI: 10.5152/tjg.2018.17112
Table 1. Demographic characteristics and features of the patients

                          With              Without
                          fluoroscopic      fluoroscopic
                          guidance          guidance
Variable                  (n=46)            (n=16)            p

Age (years)               58.8[+ or -]11.7  56.6[+ or -]13.3  0.535
Sex, n (%)
 Male                     33 (71.74%)       13 (81.25%)       0.458
 Female                   13 (28.26%)        3 (18.75%)
Tumor site, n (%)
 Upper esophagus           7 (15.22%)        3 (18.75%)       0.743
 Mid-esophagus            30 (65.22%)       11 (68.75%)       0.799
 Lower esophagus           9 (19.56%)        2 (12.5%)        0.527
Tracheoesophageal         13 (28.26%)        3 (18.75%)       0.458
fistula, n (%)
Lesion extent (cm)         8.4[+ or -]2.8    7.5[+ or -]2.1   0.274
Type of carcinoma, n (%)
 Squamous cell carcinoma  41 (89.13%)       14 (87.5%)        0.860
 Adenocarcinoma            4 (8.7%)          2 (12.5%)        0.660
 Undifferentiated          1 (2.17%)         0 (0%)           0.555

Table 2. Outcomes and results

                         With              Without
                         fluoroscopic      fluoroscopic
                         guidance          guidance
Variable                 (n=46)            (n=16)            p

Dysphagia score
 Before                  2.8[+ or -]0.58   3[+ or -]0.63     0.453
 After                   0.39[+ or -]0.57  0.43[+ or -]0.62  0.798
Mean procedure duration  15 min 4s         2 min 53sec       0.001
Technical success rate   97.82%            100%              0.555
No. of experts (main+    1+1               1+0
assistant) involved

Table 3. Post-procedure complications

                                 With          Without
                                 fluoroscopic  fluoroscopic
                                 guidance      guidance
Variable                         (n=46)        (n=16) p

Immediate complications
SEMS repositioning
 Stent removal                   12 (26.08%)   0 (0%) 0 (0%)
 Perforation                      1 (2.17%)    1 (6.25%) 0 (0%)
Aspiration                        0 (0%)       0 (0%) 0.096
 Delivery system entrapment       2 (4.35%)    0 (0%) 0.555
 Procedure-related mortality      0 (0%)       0 (0%) 0.400
Early complications
([less than or equal to]7 days)
 Chest pain                      14 (30.43%)   4 (25%) 0.682
 Nausea and vomiting              9 (19.56%)   3 (18.75%) 0.944
Upper gastrointestinal            1 (2.17%)    0 (0%) 0.555
 bleeding
Late complications (>7 days)
 Gastroesophageal reflux          6 (14.28%)   3 (20%) 0.606
 Tumor outgrowth                 10 (23.80%)   4 (26.67 %) 0.827
 Migration                        2 (4.76%)    0 (0%) 0.394
 Bleeding                         0 (0 %)      0 (0%)
Food impaction                    4 (9.52%)    1 (6.67%) 0.739
Lost to follow-up                 4            1

Table 4. Comparison between various methods of esophageal SEMS
placement


S.No.

1.     Fluoroscopy
2.     Exposure to radiation
3.     Placement of external/internal marker
4.     Number of experts needed
5.     Simultaneous use of stent assembly and endoscopy
6.     Duration of the procedure
7.     Patient comfort

       Under fluoroscopic  Under endoscopic  Simplified
S.No.  guidance            guidance          technique

1.     Needed              Not needed        Not needed
2.     Present             Absent            Absent
3.     Required            Not required      Not required
4.     Two                 Two               One
5.     No                  Yes               No
6.     Long                Short             Very short
7.     Good                Not good          Good
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Title Annotation:ORIGINAL ARTICLE
Author:Kini, Ratnakar; Ramanathan, Sabarinathan; Thangavel, Pugazhendhi; Karunakaran, Premkumar; Mohamed, K
Publication:The Turkish Journal of Gastroenterology
Date:Jan 1, 2018
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