Trial Outcomes & Findings for Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection (NCT NCT02160808)

NCT ID: NCT02160808

Last Updated: 2020-03-31

Results Overview

Outcome based on revised ISGPS Guidelines which require a three day drain amylase concentration greater than 3x the normal serum amylase concentration. Biochemical leaks are the mildest for of fistula which have no clinical consequence. Grade B fistula are more severe requiring usually percutaneous drainage placement. Grade C fistula are most severe resulting in significant morbidity and/or death.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 170 participants
• Primary outcome timeframe: 3 days
• Results posted on: 2020-03-31

Participant Flow

Participant milestones

Measure	Secretin Stimulate pancreatic secretion Secretin: Drug to stimulate pancreatic secretion	Saline Placebo should not stimulate the pancreas to release its fluids Placebo
Overall Study STARTED	87	83
Overall Study COMPLETED	87	83
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Secretin n=87 Participants Stimulate pancreatic secretion Secretin: Drug to stimulate pancreatic secretion	Saline n=83 Participants Placebo should not stimulate the pancreas to release its fluids Placebo	Total n=170 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 12.3 • n=87 Participants	63.5 years STANDARD_DEVIATION 12.1 • n=83 Participants	63.45 years STANDARD_DEVIATION 12.15 • n=170 Participants
Sex: Female, Male Female	43 Participants n=87 Participants	33 Participants n=83 Participants	76 Participants n=170 Participants
Sex: Female, Male Male	44 Participants n=87 Participants	50 Participants n=83 Participants	94 Participants n=170 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index	26.6 kg/m^2 STANDARD_DEVIATION 5.0 • n=87 Participants	26.7 kg/m^2 STANDARD_DEVIATION 6.3 • n=83 Participants	26.65 kg/m^2 STANDARD_DEVIATION 5.8 • n=170 Participants

PRIMARY outcome

Timeframe: 3 days

Outcome based on revised ISGPS Guidelines which require a three day drain amylase concentration greater than 3x the normal serum amylase concentration. Biochemical leaks are the mildest for of fistula which have no clinical consequence. Grade B fistula are more severe requiring usually percutaneous drainage placement. Grade C fistula are most severe resulting in significant morbidity and/or death.

Outcome measures

Measure	Secretin n=87 Participants Stimulate pancreatic secretion Secretin: Drug to stimulate pancreatic secretion	Saline n=83 Participants Placebo should not stimulate the pancreas to release its fluids Placebo
Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula Biochemical Leak	25 Participants	16 Participants
Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula Grade B Fistula	3 Participants	5 Participants
Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula Grade C Fistula	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through completion of intra-operative intervention and subsequent biochemical leak, B/C Fistula up to 30 days post-operatively

Following the administration of Secretin or Placebo intraoperatively, the surgeon will have the opportunity to evaluate the anastomosis to determine if there is ongoing leak. If there is ongoing leak, then the surgeon will be able to treat the leak intra-operatively prior to operative closure. In those patients in whom an intervention was performed, they were subsequently evaluated to determine if they developed a biochemical leak or grade B/C fistula.

Outcome measures

Measure	Secretin n=87 Participants Stimulate pancreatic secretion Secretin: Drug to stimulate pancreatic secretion	Saline n=83 Participants Placebo should not stimulate the pancreas to release its fluids Placebo
Number of Participants With Intra-operative Intervention, Subsequent Biochemical Leak or B/C Fistula After Drug Administration Subsequent Biochemical Leak	8 Participants	2 Participants
Number of Participants With Intra-operative Intervention, Subsequent Biochemical Leak or B/C Fistula After Drug Administration Subsequent B/C Fistula	0 Participants	1 Participants
Number of Participants With Intra-operative Intervention, Subsequent Biochemical Leak or B/C Fistula After Drug Administration Intervention	8 Participants	3 Participants

SECONDARY outcome

Timeframe: Duration of study - average 30 days

Surrogate marker for operative success

Outcome measures

Measure	Secretin n=87 Participants Stimulate pancreatic secretion Secretin: Drug to stimulate pancreatic secretion	Saline n=83 Participants Placebo should not stimulate the pancreas to release its fluids Placebo
Length of Hospitalization	10.3 Days Standard Deviation 6.5	10.2 Days Standard Deviation 5.5

Adverse Events

Secretin

Serious events: 15 serious events

Other events: 36 other events

Deaths: 0 deaths

Saline

Serious events: 32 serious events

Other events: 23 other events

Deaths: 1 deaths

Serious adverse events

Measure	Secretin n=87 participants at risk Stimulate pancreatic secretion Secretin: Drug to stimulate pancreatic secretion	Saline n=83 participants at risk Placebo should not stimulate the pancreas to release its fluids Placebo
Hepatobiliary disorders Bile Leak	1.1% 1/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	3.6% 3/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Deep Surgical Site Infection	3.4% 3/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	3.6% 3/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Gastrointestinal disorders Gastroparesis	0.00% 0/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	1.2% 1/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Hemorrhage	6.9% 6/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	12.0% 10/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Hernia	0.00% 0/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	1.2% 1/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Cardiac disorders Hypotension	0.00% 0/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	2.4% 2/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Infections and infestations Infection - other	1.1% 1/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	2.4% 2/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Gastrointestinal disorders Pancreatitis	0.00% 0/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	2.4% 2/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Infections and infestations Superficial surgical site infection	1.1% 1/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	7.2% 6/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Other	3.4% 3/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	2.4% 2/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days

Other adverse events

Measure	Secretin n=87 participants at risk Stimulate pancreatic secretion Secretin: Drug to stimulate pancreatic secretion	Saline n=83 participants at risk Placebo should not stimulate the pancreas to release its fluids Placebo
Hepatobiliary disorders Chyle Leak	3.4% 3/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	1.2% 1/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Deep Surgical Site Infection	1.1% 1/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	0.00% 0/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Gastrointestinal disorders Gastroparesis	2.3% 2/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	1.2% 1/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Hemorrhage	3.4% 3/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	6.0% 5/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Hernia	0.00% 0/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	1.2% 1/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Cardiac disorders Hypertension	8.0% 7/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	2.4% 2/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Cardiac disorders Hypotension	11.5% 10/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	6.0% 5/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Infections and infestations Infection - other	1.1% 1/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	3.6% 3/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Superficial Surgical Site Infection	6.9% 6/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	4.8% 4/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days
Surgical and medical procedures Other	3.4% 3/87 • Study enrollment until 30 days post-hospital discharge, an average of 45 days	1.2% 1/83 • Study enrollment until 30 days post-hospital discharge, an average of 45 days

Additional Information

Timothy B. Gardner MD MS

Dartmouth-Hitchcock Medical Center

Phone: 603-650-6472

Email: timothy.b.gardner@hitchcock.org

Results disclosure agreements

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