Segmented, self-expanding metal stents (S-SEMS) in patients with malignant stenoses of the esophagus or the gastroesophageal junction – a prospective, randomized, controlled study (SEGMENT study)

Segmented, self-expanding metal stents (S-SEMS) in patients with malignant stenoses of the esophagus or the gastroesophageal junction – a prospective, randomized, controlled study (SEGMENT study) - SEGMENT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035988

Enrollment

130

Registered

2025-01-23

Start date

2025-04-16

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15

Interventions

Group 1: self-expandable metallic stent (N-SEMS) Group 2: segmented self-expandable metallic stent (S-SEMS)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histologically confirmed malignant or highly suspected malignant stenosis of the esophagus or the gastroesophageal junction due to esophageal cancer (EC) or adenocarcinoma of the esophagogastric junction (AEG) Dysphagia for at least solid foods (Grade 1 or higher according to Mellow-Pinkas) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 3 Indication for esophageal stent therapy Willingness to participate in the study Written informed consent obtained

Exclusion criteria

Exclusion criteria: Stenosis length > 80 mm Lack of capacity to give consent Surgically altered anatomy of the esophagus or stomach Planned surgical resection with curative intent Significant coagulation impairment (Spontaneous Quick 50 sec, Platelet count < 50/nl) Patient receiving dual antiplatelet therapy Patient receiving single antiplatelet therapy in combination with a plasma coagulation inhibitor (Heparin, DOAC, Vitamin K antagonist) Existing pregnancy History of esophageal stenting

Design outcomes

Primary

Measure	Time frame
Rate of severe stent-associated complications (bleeding, perforation, fistulas, and death) within the study period (Day 0 to Day 90)	—

Secondary

Measure	Time frame
Technical success rate Dysphagia score on Day 2, Day 30, and Day 90 Pain according to the Visual Analog Scale (VAS) on Day 2, Day 30, and Day 90 Clinical success rate based on an improvement in dysphagia by at least 1 (Mellow-Pinkas score) on Day 30 Stent-associated bleeding requiring intervention Stent-associated perforation Stent-associated fistulas Stent-associated death Rate of stent migration Rate of stent occlusion Rate of stent-associated adverse events (AEs) Rate of stent-associated severe adverse events (SAEs) Re-intervention rate 90-day mortality rate (all-cause mortality)	—

Measure

Time frame

Technical success rate Dysphagia score on Day 2, Day 30, and Day 90 Pain according to the Visual Analog Scale (VAS) on Day 2, Day 30, and Day 90 Clinical success rate based on an improvement in dysphagia by at least 1 (Mellow-Pinkas score) on Day 30 Stent-associated bleeding requiring intervention Stent-associated perforation Stent-associated fistulas Stent-associated death Rate of stent migration Rate of stent occlusion Rate of stent-associated adverse events (AEs) Rate of stent-associated severe adverse events (SAEs) Re-intervention rate 90-day mortality rate (all-cause mortality)

—

Countries

Germany

Contacts

Public ContactThomas von Hahn

Asklepios Klinik Barmbek

t.hahn@asklepios.com+4940181882-3811

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026