Optimising Dysphagia Palliation in Oesophageal Cancer: Comparative Effectiveness of SEMS and Radiotherapy

Background and Clinical Context

Self-Expanding Metal Stents (SEMS)

Mechanism and Technique

ESGE 2021 Guideline Recommendations

1. SEMS (partially or fully covered) are recommended for palliation of malignant dysphagia over laser therapy, photodynamic therapy, and surgical bypass — strong recommendation, high quality evidence.
2. Brachytherapy is a valid alternative, alone or combined with stenting, for patients with longer life expectancy — strong recommendation, high quality evidence.
3. SEMS is the preferred treatment for malignant tracheo-oesophageal or broncho-oesophageal fistulas.
4. SEMS placement during concurrent external radiotherapy is NOT recommended due to high adverse event risk.

Complications

Radiotherapy for Dysphagia Palliation

External Beam Radiotherapy (EBRT)

• 20 Gy in 5 fractions (short course)
• 30 Gy in 10 fractions
• 20 Gy in 5 × 4 Gy fractions (hypofractionated)

Intraluminal Brachytherapy (BT)

• Median dysphagia-free survival (DyFS): 99 days
• Median overall survival: 175.5 days
• G3–G4 toxicities: fistula 8.3%, stenosis 12.2%
• Conclusion: BT is an effective and safe treatment and its underuse is "no longer justified"

Head-to-Head Evidence: Key Trials

ROCS Trial — The Landmark Phase III RCT

• SEMS + usual care (n=102)
• SEMS + EBRT (20 Gy/5 fx or 30 Gy/10 fx) + usual care (n=97)

Radioactive (Irradiation) Stents — An Emerging Hybrid

• No significant differences in dysphagia score improvement, stent restenosis, migration, chest pain, or haemorrhage
• Significantly longer time to restenosis (p < 0.00001)
• Significantly prolonged survival (p < 0.00001)

Comparative Effectiveness Summary

Clinical Decision Framework

Life Expectancy <3 Months / Severe Dysphagia

Life Expectancy >3 Months

Recurrent Dysphagia After Radiotherapy

The Combined Approach (SEMS + Radiotherapy)

• Concurrent EBRT + SEMS: Not recommended (ESGE strong recommendation) — risk of fatal aortic bleeding and fistula formation.
• Sequential EBRT after SEMS (ROCS strategy): The ROCS phase III trial showed no benefit in dysphagia deterioration or survival. The combination was less cost-effective than stent alone, despite a reduction in bleeding events. This approach should not be routinely adopted.
• Irradiation stents: Represent a promising hybrid, delivering the rapid relief of SEMS with sustained intraluminal brachytherapy. Meta-analysis data show prolonged stent patency and survival advantage, but availability is limited to specialist centres with dosimetric planning capability.

Evidence Gaps and Future Directions

1. Optimal radiotherapy schedule for palliation: High-dose regimens (30 Gy/10 fx) appear superior to low-dose (20 Gy/5 fx) for dysphagia control but may not suit frail patients. Dose-optimisation trials are needed.
2. EBRT vs. BT: Emerging data favour short-course EBRT over single-dose BT (Jeene et al.), challenging ESGE/ESMO guideline preference — prospective RCT evidence is warranted.
3. Irradiation stents: Phase III RCT data are lacking; most evidence derives from Asian centres. Broader validation is needed before routine adoption.
4. Nutritional co-intervention: The ROCS qualitative sub-study highlighted the profound multidimensional burden of eating restriction in both arms — nutritional optimisation and psychosocial support require parallel attention alongside mechanical palliation.
5. Patient-reported outcome selection: The EORTC QLQ-OG25 dysphagia scale (≥11-point threshold used in ROCS) may not capture all clinically meaningful changes — harmonised PRO endpoints across future trials are essential.

Key References

• Spaander MCW et al. ESGE Guideline Update 2021. Endoscopy 2021. [PMID 33930932]
• Adamson D et al. ROCS RCT. Lancet Gastroenterol Hepatol 2021. [PMID 33610215]
• Adamson D et al. ROCS HTA Report. Health Technol Assess 2021. [PMID 34042566]
• Yang ZM et al. Radioactive Stent Meta-Analysis. J Laparoendosc Adv Surg Tech 2021. [PMID 32915105]
• Lancellotta V et al. AIRO Brachytherapy Systematic Review. Brachytherapy 2020. [PMID 31636025]
• Jeene PM et al. EBRT vs. Brachytherapy Matched Comparison. J Thorac Oncol 2020. [PMID 32407795]
• Jooya A et al. Systematic Review: BT for Symptom Palliation. Brachytherapy 2022. [PMID 36085137]
• Clinical Gastrointestinal Endoscopy Expert Consult, 3rd ed. Chapter 28: Endoscopic Management of Oesophageal Cancer.

Summary

RESEARCH SYNOPSIS

Title

Principal Investigator

Co-Investigators

Department

Institution

1. Background and Rationale

2. Aims and Objectives

Primary Aim

Primary Objective

• To compare dysphagia score improvement (using the validated Ogilvie Dysphagia Score or equivalent institutional scale) at 4 weeks post-intervention between the SEMS and radiotherapy groups.

Secondary Objectives

1. To compare overall survival (OS) from date of palliative intervention to death or last follow-up.
2. To compare time to re-intervention (second SEMS, additional radiotherapy, or other rescue therapy) as a surrogate for durability of dysphagia relief.
3. To document and compare complication and adverse event rates (stent migration, tumour ingrowth/overgrowth, perforation, fistula formation, radiation oesophagitis, bleeding events) between the two groups.
4. To assess health-related quality of life (HRQoL) using available patient-reported outcome data (EORTC QLQ-C30 / QLQ-OES18 or equivalent, where recorded).
5. To identify clinical and tumour characteristics (histological subtype, tumour location, stage, ECOG performance status, prior chemoradiotherapy) associated with differential response to each modality.
6. To describe the treatment sequencing patterns (SEMS-first vs. radiotherapy-first; combined or sequential use) in routine practice.

3. Study Design

• Group A: Patients who received SEMS as primary palliation for dysphagia.
• Group B: Patients who received radiotherapy (EBRT and/or BT) as primary palliation for dysphagia.

4. Study Population

Inclusion Criteria

1. Histologically or cytologically confirmed oesophageal carcinoma (squamous cell carcinoma or adenocarcinoma).
2. Clinically incurable disease (metastatic, locally advanced unresectable, or deemed unsuitable for curative-intent treatment by the MDT).
3. Dysphagia as a documented indication for palliative intervention (Ogilvie score ≥ 2, or equivalent documented clinical severity).
4. Receipt of SEMS placement or palliative radiotherapy (EBRT or BT) as the primary dysphagia intervention between January 2017 and December 2023.
5. Age ≥ 18 years at time of intervention.
6. Adequate baseline clinical documentation in the medical record.

Exclusion Criteria

1. Patients who underwent SEMS as a bridge to surgery or pre-operative chemoradiotherapy.
2. Patients receiving SEMS and concurrent EBRT (simultaneous combination — due to known high adverse event risk and confounding).
3. Patients with benign oesophageal strictures.
4. Patients with incomplete records precluding extraction of baseline dysphagia score, intervention details, or any outcome data.
5. Patients who received only palliative chemotherapy without SEMS or radiotherapy for dysphagia.

5. Sample Size Considerations

6. Data Collection

Source of Data

• Electronic patient records (EPR) and hospital information systems
• Endoscopy procedure logs and radiology reports
• Oncology clinic letters and MDT meeting records
• Radiotherapy planning and treatment records
• Pathology and histology databases
• Mortality records (hospital and national death registers, where accessible)

Variables to be Collected

• Age, sex
• ECOG performance status at time of intervention
• BMI / nutritional status (albumin, weight)
• Comorbidities (Charlson Comorbidity Index)

• Histological type (SCC vs. adenocarcinoma)
• Tumour location (upper, middle, lower third; GEJ involvement)
• Tumour length and degree of luminal obstruction
• Clinical/pathological stage (TNM staging)
• Presence of tracheo-oesophageal or bronchoesophageal fistula

• SEMS group: Stent type, covering type, diameter, deployment technique, fluoroscopic vs. endoscopic guidance, procedural complications
• Radiotherapy group: Modality (EBRT vs. BT), dose/fractionation schedule, radiation technique, treatment completion
• Prior or subsequent oncological therapy (chemotherapy, chemoradiotherapy)

• Dysphagia score (pre- and post-intervention at 2 weeks, 4 weeks, 3 months)
• Date and reason for re-intervention
• Adverse events (as defined by Common Terminology Criteria for Adverse Events [CTCAE] v5.0 where applicable)
• Date of death or last follow-up
• QoL scores (where documented)

7. Statistical Analysis Plan

Descriptive Analysis

• Continuous variables: mean ± SD or median (IQR) depending on normality (Shapiro-Wilk test)
• Categorical variables: frequencies and percentages
• Baseline comparisons between groups: independent samples t-test or Mann-Whitney U test (continuous); chi-square or Fisher's exact test (categorical)

Primary Outcome

• Dysphagia score improvement at 4 weeks compared between groups using Mann-Whitney U test (ordinal scale)
• Proportion achieving clinically meaningful improvement (≥1 Ogilvie point) compared using chi-square test with odds ratio (OR) and 95% confidence interval (CI)

Secondary Outcomes

• Overall survival: Kaplan-Meier survival curves with log-rank test; Cox proportional hazards regression for adjusted hazard ratios (HR) with 95% CI
• Time to re-intervention: Kaplan-Meier analysis; competing risks regression (Fine-Gray model) with death as a competing event
• Adverse events: Compared between groups using chi-square or Fisher's exact test
• QoL: Descriptive analysis; paired comparison within groups using Wilcoxon signed-rank test where longitudinal data are available

Adjustment for Confounding

Subgroup Analyses

• By histological subtype (SCC vs. adenocarcinoma)
• By estimated performance status (ECOG 0–1 vs. 2–3)
• By tumour location (proximal/mid vs. distal/GEJ)
• By prior chemoradiotherapy exposure

8. Ethical Considerations

Study Type and Consent

Data Privacy and Confidentiality

• All data will be anonymised/pseudonymised prior to analysis. A unique study ID will replace all patient identifiers.
• Data will be stored in a password-protected, encrypted database accessible only to the named investigators.
• Data will be retained in accordance with institutional and national data retention guidelines and will not be shared with third parties.
• The study will be conducted in full compliance with applicable data protection legislation (e.g., GDPR or national equivalent).

Risk-Benefit Assessment

Conflict of Interest

9. Limitations

1. Retrospective design: Subject to selection bias and confounding by indication — patients with more severe dysphagia or worse performance status may have preferentially received SEMS over radiotherapy.
2. Inconsistent documentation: Dysphagia scoring and QoL assessment may not have been systematically recorded across the full study period; missing data are anticipated.
3. Treatment heterogeneity: Radiotherapy schedules and stent types varied over time, introducing clinical heterogeneity within arms.
4. Survival ascertainment: Completeness of follow-up and mortality data depends on linkage with hospital and national records.
5. Lack of randomisation: Despite propensity score adjustment, residual confounding from unmeasured variables cannot be excluded.

10. Expected Outcomes and Significance

• Provide the first detailed real-world characterisation of SEMS vs. radiotherapy outcomes at a tertiary cancer centre over a 7-year period.
• Identify patient subgroups who benefit most from each modality, informing personalised MDT decision-making.
• Generate preliminary data to support a future prospective study or quality improvement initiative.
• Contribute to the limited literature on palliative dysphagia management in non-trial populations, where patient characteristics frequently differ from RCT eligibility criteria.

11. Timeline

12. References

1. Adamson D et al. Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 RCT. Lancet Gastroenterol Hepatol 2021. [PMID 33610215]
2. Spaander MCW et al. Esophageal stenting for benign and malignant disease: ESGE Guideline Update 2021. Endoscopy 2021. [PMID 33930932]
3. Lancellotta V et al. The role of palliative interventional radiotherapy (brachytherapy) in esophageal cancer. Brachytherapy 2020. [PMID 31636025]
4. Yang ZM et al. Radioactive Stent for Malignant Esophageal Obstruction: A Meta-Analysis of RCTs. J Laparoendosc Adv Surg Tech 2021. [PMID 32915105]
5. Jeene PM et al. Short-Course EBRT Versus Brachytherapy for Palliation of Dysphagia. J Thorac Oncol 2020. [PMID 32407795]
6. Jooya A et al. Systematic review of brachytherapy for symptom palliation. Brachytherapy 2022. [PMID 36085137]
7. Clinical Gastrointestinal Endoscopy Expert Consult, 3rd ed. Chapter 28.

Declaration

Notes for completion before submission:

• Insert your full name, designation, department, and institutional affiliation throughout.
• Specify the dysphagia scoring tool used at your centre (Ogilvie, Mellow-Pinkas, or EORTC QLQ-OES18 dysphagia subscale).
• Confirm your institution's data governance and ethics committee submission form requirements and attach this synopsis as the narrative section.
• A cover letter to the ethics committee chair, signed consent waiver request, and CV of the PI are typically required as supplementary documents.

RESEARCH SYNOPSIS — REVISED

Title

Principal Investigator

Co-Investigators

Department

Institution

1. Background and Rationale

1. Dysphagia — present in 80–90% of patients, leading to nutritional failure, aspiration risk, and progressive functional decline.
2. Pain — oesophageal, retrosternal, and back pain arising from tumour infiltration, peritumoural inflammation, and neural invasion; present in a significant proportion of patients and inadequately captured in most palliative intervention trials.

• Self-Expanding Metal Stents (SEMS): Endoscopically deployed mechanical stents that restore luminal patency within 24–48 hours. The ESGE 2021 guidelines (Spaander et al.) issue a strong recommendation for SEMS as the first-line intervention for malignant dysphagia, particularly in patients with short life expectancy. However, SEMS are associated with significant complication rates (stent obstruction 30–40%, migration, fistula, haemorrhage) and carry no tumour cytoreductive effect — and therefore limited value in pain palliation arising from tumour mass effect.
• Radiotherapy (EBRT / Brachytherapy): Palliative external beam radiotherapy (typically 20–30 Gy in 5–10 fractions) or intraluminal brachytherapy acts through tumour volume reduction, offering both luminal relief and reduction of pain from local infiltration. The onset of dysphagia relief is delayed (4–6 weeks), but the duration is more sustained. Critically, radiotherapy has a well-recognised role in pain palliation from locally advanced thoracic tumours — a benefit absent from mechanical stenting.

2. Aims and Objectives

Primary Aims

1. To compare the effectiveness of SEMS versus radiotherapy in relieving dysphagia at 4 weeks post-intervention.
2. To compare the effectiveness of SEMS versus radiotherapy in reducing pain at 4 weeks post-intervention.

Primary Objectives

• Dysphagia: To compare the proportion of patients achieving clinically meaningful dysphagia improvement (≥1-point reduction on the Ogilvie Dysphagia Score, or equivalent) at 4 weeks between the SEMS and radiotherapy groups.
• Pain: To compare the proportion of patients achieving clinically meaningful pain reduction (≥2-point reduction on the Numerical Rating Scale [NRS] 0–10, or equivalent documented pain score) at 4 weeks between the SEMS and radiotherapy groups.

Secondary Objectives

1. To compare overall survival (OS) from the date of palliative intervention to death or last follow-up between the two groups.
2. To compare time to re-intervention (rescue stent, repeat radiotherapy, or other dysphagia intervention) as a measure of durability of dysphagia relief.
3. To compare complication and adverse event rates — including stent migration, tumour ingrowth/overgrowth, perforation, fistula formation, radiation oesophagitis, and haemorrhage — between the two groups.
4. To assess health-related quality of life (HRQoL) using available patient-reported outcome data (EORTC QLQ-C30 / QLQ-OES18 dysphagia, pain, and eating restriction domains, where documented).
5. To evaluate change in nutritional status (body weight, serum albumin) from baseline to 4 and 12 weeks.
6. To identify clinical and tumour factors associated with differential response to each modality in both dysphagia and pain palliation.

3. Study Design

• Group A (SEMS): Treatment-naive patients who received SEMS as the primary palliative intervention for dysphagia.
• Group B (Radiotherapy): Treatment-naive patients who received palliative EBRT or intraluminal brachytherapy as the primary palliative intervention.

4. Study Population

Inclusion Criteria

1. Histologically or cytologically confirmed oesophageal carcinoma (squamous cell carcinoma or adenocarcinoma) or oesophagogastric junction (OGJ) carcinoma.
2. Locally advanced (T3/T4 or N+, unresectable) or metastatic (Stage IV) disease at the time of intervention, as documented by clinical staging workup.
3. Treatment-naive: No prior receipt of any anticancer therapy — including systemic chemotherapy, targeted therapy, immunotherapy, surgical resection, radical-intent radiotherapy, or chemoradiotherapy — at any time prior to the study intervention.
4. Unfit for standard anticancer treatment as determined by the multidisciplinary team (MDT), based on one or more of the following: ECOG performance status ≥ 3, significant comorbidity precluding systemic therapy or surgery, patient refusal of anticancer treatment, or clinician judgement of treatment futility.
5. Receipt of SEMS placement or palliative radiotherapy (EBRT or BT) as the primary intervention for dysphagia or pain between January 2017 and December 2023.
6. A documented baseline dysphagia score and/or pain score (NRS or equivalent) within 2 weeks prior to intervention.
7. Age ≥ 18 years at time of intervention.
8. Adequate follow-up documentation at a minimum of 4 weeks post-intervention.

Exclusion Criteria

1. Any prior anticancer treatment (chemotherapy, immunotherapy, targeted therapy, surgery, or radical radiotherapy) before the study intervention.
2. Patients undergoing SEMS as a bridge to surgery or before preoperative chemoradiotherapy.
3. Patients receiving SEMS and concurrent EBRT simultaneously (not a pure monotherapy arm).
4. Benign oesophageal strictures or non-malignant indications for intervention.
5. Patients with incomplete records precluding extraction of baseline and at least one post-intervention assessment of dysphagia or pain.
6. Patients with a documented life expectancy of less than 2 weeks at time of intervention, where meaningful outcome assessment is not feasible.

5. Sample Size Considerations

6. Data Collection

Source of Data

• Electronic patient records (EPR) and hospital information systems
• Endoscopy procedure logs and radiology/fluoroscopy reports
• Oncology and gastroenterology clinic letters and MDT records
• Radiotherapy planning, dosimetry, and treatment completion records
• Pain assessment documentation (nursing notes, oncology clinic assessments, analgesic prescription records)
• Pathology and histology databases
• Nutritional assessment records (dietitian notes, weight charts, albumin results)
• Mortality records (hospital, national death registers where accessible)

Variables to be Collected

• Age, sex, ethnicity
• ECOG performance status at time of intervention
• BMI, body weight, serum albumin
• Comorbidity burden (Charlson Comorbidity Index)
• Reason for unfitness for standard therapy (performance status, comorbidity, patient choice, MDT decision)

• Histological subtype (SCC vs. adenocarcinoma)
• Tumour location (upper / middle / lower third; OGJ)
• Tumour length and degree of luminal obstruction on endoscopy or imaging
• Clinical stage (TNM 8th edition)
• Presence of tracheo-oesophageal or broncho-oesophageal fistula
• Pattern of metastatic spread (nodal only, distant organ, peritoneal)

• SEMS group: Stent brand/type, covering (full/partial/uncovered), diameter, technique (fluoroscopic ± endoscopic), procedural complications, stent patency duration
• Radiotherapy group: Modality (EBRT vs. BT), dose and fractionation (total dose, fraction size, number of fractions), technique (2D vs. 3D-conformal), treatment completion (complete vs. incomplete)

• Dysphagia score (Ogilvie scale or equivalent): baseline, 2 weeks, 4 weeks, 3 months
• Pain score (NRS 0–10 or VAS): baseline, 2 weeks, 4 weeks, 3 months
• Analgesic use and WHO ladder step at baseline and follow-up (as proxy for pain burden)

• Date and cause of death / last follow-up date
• Date and type of re-intervention for dysphagia or pain
• Adverse events (documented complications, graded by CTCAE v5.0 where possible)
• Body weight and serum albumin at 4 and 12 weeks
• QoL scores (EORTC QLQ-C30 / QLQ-OES18 or equivalent, where recorded)

7. Statistical Analysis Plan

Descriptive Analysis

• Continuous variables: mean ± SD or median (IQR) based on distribution (Shapiro-Wilk)
• Categorical variables: frequencies and percentages
• Baseline group comparisons: independent t-test or Mann-Whitney U (continuous); chi-square or Fisher's exact test (categorical)

Co-Primary Outcome Analysis

• Dysphagia: Proportion achieving ≥1-point Ogilvie improvement at 4 weeks compared using chi-square test; OR with 95% CI. Change in ordinal score compared using Mann-Whitney U test.
• Pain: Proportion achieving ≥2-point NRS reduction at 4 weeks compared using chi-square test; OR with 95% CI. Change in continuous NRS score compared using independent t-test or Mann-Whitney U test as appropriate.

Secondary Outcome Analysis

• Overall survival: Kaplan-Meier curves with log-rank test; multivariable Cox proportional hazards regression (adjusted HR, 95% CI), adjusting for age, ECOG PS, stage, histology
• Time to re-intervention: Kaplan-Meier analysis; Fine-Gray competing risks regression (death as competing event)
• Adverse events: Chi-square / Fisher's exact test for between-group comparison
• Nutritional parameters: Paired Wilcoxon signed-rank test within groups; Mann-Whitney U between groups
• QoL: Descriptive; paired within-group comparison using Wilcoxon signed-rank test where longitudinal data exist

Adjustment for Confounding

Subgroup Analyses

• Histological subtype (SCC vs. adenocarcinoma)
• Performance status (ECOG 2 vs. ≥3)
• Tumour location (proximal/middle vs. distal/OGJ)
• Stage (locally advanced vs. metastatic)
• Radiotherapy modality (EBRT vs. BT) — within the radiotherapy arm

8. Ethical Considerations

Study Type and Consent Waiver

• All patients are being managed under routine clinical care; the study involves no additional burden
• Retrospective record review of this nature is recognised as appropriate without individual consent under national and international ethical guidelines for non-interventional research
• Data will be fully anonymised prior to analysis

Data Privacy and Security

• All patient identifiers will be replaced with unique study codes prior to data entry into the analytical database.
• Data will be stored in a password-protected, encrypted electronic database on an institutional server, accessible only to named investigators.
• Data will be handled in strict compliance with applicable data protection legislation (GDPR / national equivalent) and institutional information governance policy.
• Original identifiable extraction sheets will be stored securely and destroyed at study completion per institutional policy.

Risk-Benefit Assessment

Declaration of Interests

9. Limitations

1. Retrospective design with selection bias: Patients were not randomised; the choice of SEMS vs. radiotherapy was determined by clinician judgement and patient factors. Patients with more severe dysphagia, worse PS, or tumour-related fistulae may have been disproportionately directed to SEMS. Propensity score methods will mitigate but cannot fully eliminate this.
2. Pain documentation variability: Systematic pain scoring (NRS/VAS) may not have been uniformly recorded across all clinic encounters throughout the study period. Analgesic prescription records will be used as a supplementary proxy where formal scores are absent.
3. Treatment heterogeneity within arms: Radiotherapy fractionation schedules and stent designs varied over the 7-year period. Subgroup and sensitivity analyses will address intra-arm heterogeneity.
4. Outcome ascertainment completeness: Not all patients will have documented 4-week assessments; those lost to follow-up before the primary endpoint will require appropriate missing data handling (multiple imputation or complete-case sensitivity analysis).
5. Unmeasured confounders: Factors such as opioid co-prescription, performance status trajectory, nutritional support intensity, and social support — which influence both pain experience and functional outcomes — may not be systematically captured in the medical record.
6. Single-centre experience: Results may reflect institutional referral patterns and local practice norms; generalisability to other settings requires external validation.

10. Expected Outcomes and Significance

• Generate the first dedicated comparative analysis of pain and dysphagia palliation by SEMS versus radiotherapy in a treatment-naive, unfit oesophageal cancer population, addressing a critical evidence gap.
• Provide real-world, institutional evidence to guide individualised MDT decisions about palliative treatment allocation in this underserved group.
• Characterise the safety profile of each modality in a population who have not received prior therapies that could amplify complications (e.g., radiation-induced wall fragility, chemotherapy-related neutropenia).
• Generate pilot data to inform the design and sample size of a future prospective study or pragmatic RCT targeting this specific patient population.
• Contribute to the national and international evidence base on pain palliation in oesophageal cancer, an outcome currently not designated as a primary endpoint in existing phase III trials.

11. Timeline

12. References

1. Adamson D et al. Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 RCT. Lancet Gastroenterol Hepatol 2021. [PMID 33610215]
2. Adamson D et al. ROCS RCT — Health Technology Assessment. Health Technol Assess 2021. [PMID 34042566]
3. Spaander MCW et al. Esophageal stenting for benign and malignant disease: ESGE Guideline Update 2021. Endoscopy 2021. [PMID 33930932]
4. Martin EJ et al. Palliative Radiotherapy Versus Esophageal Stent Placement in Metastatic Esophageal Cancer (n=1,957). J Natl Compr Canc Netw 2020. [PMID 32380466]
5. Bandhate K, Diwan A. Palliative radiotherapy and quality of life in locally advanced thoracic oesophageal cancer. Rep Pract Oncol Radiother 2022. [PMID 35402038]
6. Xu Z et al. Palliative radiotherapy combined with stent insertion for dysphagia in advanced oesophageal cancer: systematic review and meta-analysis. Front Oncol 2022. [PMID 36172146]
7. Lancellotta V et al. Role of palliative interventional radiotherapy (brachytherapy) in oesophageal cancer: AIRO systematic review. Brachytherapy 2020. [PMID 31636025]
8. Yang ZM et al. Radioactive Stent for Malignant Oesophageal Obstruction: Meta-Analysis of RCTs. J Laparoendosc Adv Surg Tech 2021. [PMID 32915105]
9. Clinical Gastrointestinal Endoscopy Expert Consult, 3rd ed. Chapter 28: Endoscopic Management of Oesophageal Cancer.

Declaration

Completion checklist before submission:

• Fill in all investigator names, designations, and institutional details
• Confirm the pain scoring tool routinely used at your centre (NRS, VAS, or EORTC QLQ-OES18 pain domain) — adjust pain primary outcome definition accordingly
• Confirm your institution's dysphagia scoring tool (Ogilvie, Mellow-Pinkas, or EORTC QLQ-OES18 dysphagia subscale)
• Attach any required supplementary documents per your ethics committee's submission checklist (e.g., PI CV, co-investigator declarations, data extraction template, data storage agreement)
• A formal consent waiver application form may need to be completed separately depending on your institution's requirements