Trial Outcomes & Findings for Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer (NCT NCT01015820)
NCT ID: NCT01015820
Last Updated: 2014-07-16
Results Overview
Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.
COMPLETED
NA
37 participants
Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
2014-07-16
Participant Flow
37 patients were enrolled in the study. Of these, 5 patients with neuroendocrine tumors and 2 patients with duodenal anatomy limiting the use of the probe were excluded because of screen failure.
Participant milestones
| Measure |
Cancer Group
Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.
|
Control Group
Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cancer Group
Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.
|
Control Group
Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
|---|---|---|
|
Overall Study
Suboptimal measurements
|
1
|
0
|
Baseline Characteristics
Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Cancer Group
n=14 Participants
Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
Control Group
n=15 Participants
Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 10 • n=5 Participants
|
63 years
STANDARD_DEVIATION 11 • n=7 Participants
|
67 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiationPopulation: Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.
Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.
Outcome measures
| Measure |
Cancer Group
n=14 Participants
Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
Control Group
n=15 Participants
Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
|---|---|---|
|
Deoxyhemoglobin Concentration (DHb)
Ampullary
|
.6968475 alpha units
95% Confidence Interval .22 • Interval 0.562102 to 0.831593
|
.3483283 alpha units
95% Confidence Interval .20 • Interval 0.2318606 to 0.4647961
|
|
Deoxyhemoglobin Concentration (DHb)
Distal 1 cm from ampullary
|
.7021826 alpha units
95% Confidence Interval .35 • Interval 0.4898464 to 0.9145189
|
.4945491 alpha units
95% Confidence Interval .28 • Interval 0.3416003 to 0.647498
|
|
Deoxyhemoglobin Concentration (DHb)
Distal periampullary
|
.4442996 alpha units
95% Confidence Interval .15 • Interval 0.3415441 to 0.5470551
|
.4831275 alpha units
95% Confidence Interval .17 • Interval 0.3904288 to 0.5758262
|
|
Deoxyhemoglobin Concentration (DHb)
Proximal 1 cm from ampulla
|
.6885187 alpha units
95% Confidence Interval .29 • Interval 0.5013549 to 0.8756826
|
.4654624 alpha units
95% Confidence Interval .34 • Interval 0.2776132 to 0.6533117
|
|
Deoxyhemoglobin Concentration (DHb)
Proximal periampullary
|
.4785118 alpha units
95% Confidence Interval .22 • Interval 0.3417855 to 0.6152382
|
.43211449 alpha units
95% Confidence Interval .33 • Interval 0.2399311 to 0.6243588
|
PRIMARY outcome
Timeframe: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiationPopulation: Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.
BVR serves as a marker for early increase of blood supply (EIBS).
Outcome measures
| Measure |
Cancer Group
n=14 Participants
Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
Control Group
n=15 Participants
Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
|
|---|---|---|
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Mean Blood Vessel Radius (BVR)
Distal Periampullary
|
.002899 cm
95% Confidence Interval .001 • Interval 0.0021021 to 0.0036958
|
.0024096 cm
95% Confidence Interval .001 • Interval 0.0021024 to 0.0027168
|
|
Mean Blood Vessel Radius (BVR)
Ampullary
|
.003088 cm
95% Confidence Interval .001 • Interval 0.0022698 to 0.0039062
|
.002035 cm
95% Confidence Interval .001 • Interval 0.0016118 to 0.0024582
|
|
Mean Blood Vessel Radius (BVR)
Distal 1 cm from Ampulla
|
.0030272 cm
95% Confidence Interval .001 • Interval 0.0022997 to 0.0037547
|
.0023467 cm
95% Confidence Interval .001 • Interval 0.0019386 to 0.0027548
|
|
Mean Blood Vessel Radius (BVR)
Proximal 1 cm from Ampulla
|
.0027802 cm
95% Confidence Interval .001 • Interval 0.0021426 to 0.0034178
|
.0020825 cm
95% Confidence Interval .001 • Interval 0.0015238 to 0.0026411
|
|
Mean Blood Vessel Radius (BVR)
Proximal Periampullary
|
.0023551 cm
95% Confidence Interval .001 • Interval 0.001627 to 0.0030832
|
.0019793 cm
95% Confidence Interval .001 • Interval 0.0014618 to 0.0024968
|
Adverse Events
Cancer Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place