Trial Outcomes & Findings for Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy (NCT NCT03179995)
NCT ID: NCT03179995
Last Updated: 2024-02-14
Results Overview
To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
0 to 120 hours post dose
Results posted on
2024-02-14
Participant Flow
Participant milestones
| Measure |
Octreotide Treatment Arm
Octreotide will be administered post-operatively until day 5
Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
|
Placebo Arm
Normal saline will be administered post-operatively until day 5
Placebo: Normal saline will be administered in the same fashion as Octreotide
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
Baseline characteristics by cohort
| Measure |
Octreotide Treatment Arm
n=11 Participants
Octreotide will be administered post-operatively until day 5
Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
|
Placebo Arm
n=12 Participants
Normal saline will be administered post-operatively until day 5
Placebo: Normal saline will be administered in the same fashion as Octreotide
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American Non-Hispanic
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 to 120 hours post dosePopulation: Data were not collected
To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeksPopulation: Data were not collected
Hepatic parenchymal regeneration will be evaluated by hepatic volume measured by CT scan pre-operatively, at 1 week post-operatively and 3 months post operatively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data were not collected
Evaluate the incidence of post-hepatectomy liver failure, bile leak, overall as well as 30-day and 90 day morbidity and mortality using American College of Surgeons-National Surgical Quality Improvement Definitions (ACS-NSQIP).
Outcome measures
Outcome data not reported
Adverse Events
Octreotide Treatment Arm
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Octreotide Treatment Arm
n=11 participants at risk
Octreotide will be administered post-operatively until day 5
Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
|
Placebo Arm
n=12 participants at risk
Normal saline will be administered post-operatively until day 5
Placebo: Normal saline will be administered in the same fashion as Octreotide
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
9.1%
1/11 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
|
Hepatobiliary disorders
Septic shock
|
0.00%
0/11 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
|
Gastrointestinal disorders
Vomitting
|
9.1%
1/11 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
|
General disorders
Dehydration
|
9.1%
1/11 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
|
General disorders
Bilateral leg swelling
|
9.1%
1/11 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
Other adverse events
| Measure |
Octreotide Treatment Arm
n=11 participants at risk
Octreotide will be administered post-operatively until day 5
Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
|
Placebo Arm
n=12 participants at risk
Normal saline will be administered post-operatively until day 5
Placebo: Normal saline will be administered in the same fashion as Octreotide
|
|---|---|---|
|
Investigations
QT prolongation
|
54.5%
6/11 • 4 weeks
|
41.7%
5/12 • 4 weeks
|
|
General disorders
lactate dehydrogenase increase
|
0.00%
0/11 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
|
Infections and infestations
septic shock due to infected biloma
|
0.00%
0/11 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
Additional Information
Protocol Development Coordinator
Fox Chase Cancer Center
Phone: 215-728-4097
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place