Trial Outcomes & Findings for Ablation of Intestinal Metaplasia Containing Dysplasia (NCT NCT00282672)
NCT ID: NCT00282672
Last Updated: 2017-11-06
Results Overview
% of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
127 participants
Primary outcome timeframe
12 month
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
LGD Sham Procedure First Then LGD Radiofrequency Ablation
After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
|
LGD Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
1 Year
STARTED
|
22
|
42
|
21
|
42
|
|
1 Year
COMPLETED
|
19
|
40
|
20
|
38
|
|
1 Year
NOT COMPLETED
|
3
|
2
|
1
|
4
|
|
2 Year: Sham Crossed Over to RFA
STARTED
|
19
|
40
|
16
|
38
|
|
2 Year: Sham Crossed Over to RFA
COMPLETED
|
16
|
39
|
15
|
36
|
|
2 Year: Sham Crossed Over to RFA
NOT COMPLETED
|
3
|
1
|
1
|
2
|
|
5 Year: Follow up
STARTED
|
15
|
32
|
12
|
25
|
|
5 Year: Follow up
COMPLETED
|
14
|
27
|
12
|
20
|
|
5 Year: Follow up
NOT COMPLETED
|
1
|
5
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ablation of Intestinal Metaplasia Containing Dysplasia
Baseline characteristics by cohort
| Measure |
LGD Sham Procedure First Then LGD Radiofrequency Ablation
n=22 Participants
After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
|
LGD Radiofrequency Ablation
n=42 Participants
|
HGD Sham Procedure First Then LGD Radiofrequency Ablation
n=21 Participants
After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
|
HGD Radiofrequency Ablation
n=42 Participants
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
65.95 years
STANDARD_DEVIATION 8.95 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
42 participants
n=7 Participants
|
21 participants
n=5 Participants
|
42 participants
n=4 Participants
|
127 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthPopulation: LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-IM at one year.
% of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated.
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=40 Participants
|
HGD:Radiofrequency Ablation
n=38 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month
|
85 percentage of participants
|
81.5 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthPopulation: LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-D at one year.
% of patients with complete eradication of Dysplasia out of the number of participants analyzed at 12 month was calculated.
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=40 Participants
|
HGD:Radiofrequency Ablation
n=38 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
The % of Patients With Complete Eradication of Dysplasia at 12 Month
|
95 percentage of participants
|
89.5 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 Month% of patients with complete eradication of IM out of the number of participants analyzed at 24 month was calculated.
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=16 Participants
|
HGD:Radiofrequency Ablation
n=39 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
n=15 Participants
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
n=36 Participants
|
|---|---|---|---|---|
|
The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months.
|
100 percentage of participants
|
97.4 percentage of participants
|
93.3 percentage of participants
|
88.9 percentage of participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: patient who made it to the 5 year visit
For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of intestinal metaplasia (CE-IM) was calculated.
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=41 Participants
|
HGD:Radiofrequency Ablation
n=32 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years
|
85.3 percentage of participants
|
96.8 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 yearPopulation: 41 LGD subjects and 32 HGD subjects completed 5 year visit
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=73 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
Durability of Eradication With no Additional Treatments
|
75 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 yearsFor patient who made it to the 5 year visit, % of patients demonstrating complete eradication of dysplasia was calculated and all were free of dysplasia
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=41 Participants
|
HGD:Radiofrequency Ablation
n=32 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years
|
100 percentage of participants
|
96.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=40 Participants
|
HGD:Radiofrequency Ablation
n=18 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
n=38 Participants
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
n=15 Participants
|
|---|---|---|---|---|
|
The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup
|
85 percentage of participants
|
72.2 percentage of participants
|
81.5 percentage of participants
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: 16 HGD Sham procedure subjects crossed over to RFA treatment after one year
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=38 Participants
|
HGD:Radiofrequency Ablation
n=15 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups.
|
89.4 percentage of participants
|
86.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months% of patients with histological clearance of IM out of the number of participants analyzed at 12 month was calculated.
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=40 Participants
|
HGD:Radiofrequency Ablation
n=18 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
n=38 Participants
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
n=15 Participants
|
|---|---|---|---|---|
|
Histological Clearance of IM (% Biopsies)
|
85 percentage of participants
|
72.2 percentage of participants
|
81.5 percentage of participants
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=47 Participants
|
HGD:Radiofrequency Ablation
n=47 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
n=37 Participants
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma)
|
5 participants
|
1 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 , if ablatedChest pain score was measured on a visual analogue scale of 0 to 100, with higher scores indicating a greater severity of pain
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=20 Participants
|
HGD:Radiofrequency Ablation
n=40 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
n=20 Participants
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
n=41 Participants
|
|---|---|---|---|---|
|
Subject Discomfort : Chest Pain Score on Day 1
|
0 Scores on a scale
Interval 0.0 to 0.0
|
26 Scores on a scale
Interval 4.0 to 48.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
22 Scores on a scale
Interval 0.0 to 57.0
|
SECONDARY outcome
Timeframe: 0, 12, and 24 monthsPopulation: Data had not been collected consistently to analyze the data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months for Treatment and Sham ComparisonData reported in the adverse event section
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=43 Participants
|
HGD:Radiofrequency Ablation
n=84 Participants
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
Adverse Event Incidence
AE's related to procedure
|
7 Adverse event occurrences
|
32 Adverse event occurrences
|
—
|
—
|
|
Adverse Event Incidence
AE's unrelated to procedure
|
17 Adverse event occurrences
|
34 Adverse event occurrences
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 41 LGD patients and 21 HGD subjects completed the 5 year study and used for analysis.
Outcome measures
| Measure |
LGD:Radiofrequency Ablation
n=73 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years)
|
2.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Similar analysis was performed and the result is provided for the outcome measure #14. The data were collected to answer the outcome measure #14.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=41 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year
|
85.4 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=41 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year
|
100 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=43 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year
|
79.1 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=42 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year
|
92.9 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=43 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year
|
93 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=127 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: Serious Adverse Event Incidence
Bleed
|
1 participants
|
—
|
—
|
—
|
|
5 Year Extension: Serious Adverse Event Incidence
Chest Pain
|
3 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
LGD:Radiofrequency Ablation
n=127 Participants
|
HGD:Radiofrequency Ablation
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Crossed over to HGD: Radiofrequency
|
HGD Radiofrequency Ablation
|
|---|---|---|---|---|
|
5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years.
|
0 percentage of participants
|
—
|
—
|
—
|
Adverse Events
LGD Sham Procedure First Then LGD Radiofrequency Ablation
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
LGD Radiofrequency Ablation
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
HGD Sham Procedure First Then HGD Radiofrequency Ablation
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
HGD Radiofrequency Ablation
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LGD Sham Procedure First Then LGD Radiofrequency Ablation
n=22 participants at risk
|
LGD Radiofrequency Ablation
n=42 participants at risk
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
n=21 participants at risk
|
HGD Radiofrequency Ablation
n=42 participants at risk
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
PAIN, NAUSEA, VOMITTING, FULLNESS, ABDOMINAL DISCOMFORT
|
4.5%
1/22 • Number of events 1
|
0.00%
0/42
|
0.00%
0/21
|
4.8%
2/42 • Number of events 2
|
|
Injury, poisoning and procedural complications
Upper GI Bleed
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
Other adverse events
| Measure |
LGD Sham Procedure First Then LGD Radiofrequency Ablation
n=22 participants at risk
|
LGD Radiofrequency Ablation
n=42 participants at risk
|
HGD Sham Procedure First Then HGD Radiofrequency Ablation
n=21 participants at risk
|
HGD Radiofrequency Ablation
n=42 participants at risk
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
MUCOSAL INJURY
|
4.5%
1/22 • Number of events 1
|
0.00%
0/42
|
0.00%
0/21
|
4.8%
2/42 • Number of events 2
|
|
Injury, poisoning and procedural complications
MELENA
|
0.00%
0/22
|
0.00%
0/42
|
0.00%
0/21
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
STRICTURE REQUIRING DILATATION
|
9.1%
2/22 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
9.5%
2/21 • Number of events 3
|
9.5%
4/42 • Number of events 4
|
|
Injury, poisoning and procedural complications
VOMITTING
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
4.8%
2/42 • Number of events 2
|
|
Injury, poisoning and procedural complications
CHEST PAIN/ THROAT PAIN / NAUSEA
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
STRICTURE / SCARRING
|
9.1%
2/22 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
BLOATED, REFLUX SENSATION, DIFFICULTY SWALLOWING
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
NARROWED ESOPHAGUS
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
ESOPHAGEAL VARICES
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
FEVER; DIARRHEA
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
PAINFUL SWALLOWING / CHEST PAIN
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
PREMATURE FULLNESS WITH MEALS
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
PAINFUL SWALLOWING, ABDOMINAL PAIN, CHEST PAIN.
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
FEVER, LARYNGITIS, PHARYNGITIS AND BRONCHITIS
|
0.00%
0/22
|
2.4%
1/42 • Number of events 1
|
0.00%
0/21
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
SEVERE NAUSEA,VOMITING, ULCERATION, WEIGHT LOSS
|
0.00%
0/22
|
0.00%
0/42
|
4.8%
1/21 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
ULCERATION
|
0.00%
0/22
|
0.00%
0/42
|
4.8%
1/21 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
DYSPHAGIA
|
0.00%
0/22
|
0.00%
0/42
|
4.8%
1/21 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
EROSIVE ESOPHAGEAL MUCOSA
|
0.00%
0/22
|
0.00%
0/42
|
4.8%
1/21 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
RIGHT EAR ACHE
|
0.00%
0/22
|
0.00%
0/42
|
4.8%
1/21 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
ABDOMINAL PAIN
|
0.00%
0/22
|
0.00%
0/42
|
0.00%
0/21
|
4.8%
2/42 • Number of events 3
|
|
Injury, poisoning and procedural complications
PAIN; ELEVATED BP
|
0.00%
0/22
|
0.00%
0/42
|
0.00%
0/21
|
2.4%
1/42 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60