Trial Outcomes & Findings for Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures (NCT NCT01661686)

NCT ID: NCT01661686

Last Updated: 2019-10-03

Results Overview

This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
• Results posted on: 2019-10-03

Participant Flow

Participant milestones

Measure	Insertion of a Partially Covered SEMS Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Overall Study STARTED	49	49
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Insertion of a Partially Covered SEMS Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Overall Study Lost to Follow-up	2	1
Overall Study did not receive allocated intervention	0	1

Baseline Characteristics

Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

Baseline characteristics by cohort

Measure	Insertion of a Partially Covered SEMS n=49 Participants Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 Participants Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Total n=97 Participants Total of all reporting groups
Age, Continuous	70.8 years STANDARD_DEVIATION 11.4 • n=5 Participants	69.2 years STANDARD_DEVIATION 12.1 • n=7 Participants	70.1 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Dysphagia score	2.8 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	2.8 units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	2.8 units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
WHO	1.4 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	1.1 units on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	1.3 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Etiology/histology stricture Adenocarcinoma	24 Participants n=5 Participants	32 Participants n=7 Participants	56 Participants n=5 Participants
Etiology/histology stricture Squamous cell carcinoma	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Etiology/histology stricture Extrinsic compression	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Etiology/histology stricture Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Presence of distant metastasis	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Previous chemotherapy	22 participants n=5 Participants	26 participants n=7 Participants	48 participants n=5 Participants
Previous radiotherapy	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants
Location stricture Proximal esophagus	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Location stricture Mid esophagus	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Location stricture Distal esophagus or cardia	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Length of tumor	6.8 cm STANDARD_DEVIATION 3.1 • n=5 Participants	7.6 cm STANDARD_DEVIATION 3.7 • n=7 Participants	7.2 cm STANDARD_DEVIATION 3.5 • n=5 Participants
Length of stricture	5.4 cm STANDARD_DEVIATION 2.6 • n=5 Participants	6.0 cm STANDARD_DEVIATION 2.9 • n=7 Participants	5.7 cm STANDARD_DEVIATION 2.8 • n=5 Participants

PRIMARY outcome

Timeframe: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.

Population: One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.

This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.

Outcome measures

Measure	Insertion of a Partially Covered SEMS n=49 Participants Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 Participants Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Number of Participants With Recurrent Dysphagia.	11 Participants	9 Participants

SECONDARY outcome

Timeframe: At stent placement (t=0)

Technical succes was defined as succesful deployment of the stent which bridges the stricture

Outcome measures

Measure	Insertion of a Partially Covered SEMS n=49 Participants Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 Participants Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Number of Participants With Technical Success of SEMS Placement	47 Participants	48 Participants

SECONDARY outcome

Timeframe: From stent placement until death or placement of second stent, assessed up to 6 months.

Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.

Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months

Outcome measures

Measure	Insertion of a Partially Covered SEMS n=49 Participants Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 Participants Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score	43 Participants	40 Participants

SECONDARY outcome

Timeframe: From stent placement until death or placement of second stent, assessed up to 6 months

A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.

Outcome measures

Measure	Insertion of a Partially Covered SEMS n=49 Participants Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 Participants Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Number of Participants in Whom a Major Complication Has Occured	23 Participants	18 Participants

SECONDARY outcome

Timeframe: From stent placement until death or placement of second stent

Survival from stent placement until death or placement of second stent

Outcome measures

Measure	Insertion of a Partially Covered SEMS n=49 Participants Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 Participants Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Median Survival After SEMS Placement	92 days Interval 5.0 to 656.0	61 days Interval 4.0 to 596.0

Adverse Events

Insertion of a Partially Covered SEMS

Serious events: 23 serious events

Other events: 4 other events

Deaths: 0 deaths

Insertion of a Fully Covered SEMS

Serious events: 18 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insertion of a Partially Covered SEMS n=49 participants at risk Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 participants at risk Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Gastrointestinal disorders Severe pain	18.4% 9/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	18.8% 9/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Respiratory, thoracic and mediastinal disorders pneumonia	18.4% 9/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	8.3% 4/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Gastrointestinal disorders mediastinitis	2.0% 1/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	0.00% 0/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Respiratory, thoracic and mediastinal disorders stridor	0.00% 0/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	4.2% 2/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Gastrointestinal disorders Hemorrhage	10.2% 5/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	8.3% 4/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Gastrointestinal disorders Fistula	6.1% 3/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	0.00% 0/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Musculoskeletal and connective tissue disorders spondyloscitis	0.00% 0/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	2.1% 1/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Gastrointestinal disorders pressure ulcer	0.00% 0/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	2.1% 1/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.

Other adverse events

Measure	Insertion of a Partially Covered SEMS n=49 participants at risk Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available	Insertion of a Fully Covered SEMS n=48 participants at risk Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Infections and infestations Fever	4.1% 2/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	2.1% 1/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Gastrointestinal disorders Mild pain	2.0% 1/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	4.2% 2/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.
Gastrointestinal disorders Esophagitis	2.0% 1/49 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.	0.00% 0/48 One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.

Additional Information

Dr. V.M.C.W. Spaander

Erasmus University Medical Center

Phone: 0031 10 703 5643

Email: v.spaander@erasmusmc.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place