Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/9/2019 |
| Start Date: | May 2014 |
| End Date: | December 2019 |
| Contact: | Timothy B Gardner |
| Email: | timothy.b.gardner@hitchcock.org |
| Phone: | 603-650-6472 |
Pancreatic leaks complicate pancreatic resection in approximately 20% of cases. The
pancreatic anastomosis or repair has been referred to as the Achilles heel of pancreatic
surgery. Unfortunately, despite recognition of this problem and multiple operative techniques
proposed to prevent this complication, leaks continue to represent a major cause of morbidity
for patients undergoing pancreatic surgery. Treatment of leaks often requires nutritional
support with total parenteral nutrition to diminish the leak in addition to invasive
interventions to contain the leak with drains, stents or in severe cases, reoperation.
Experiential data suggest that intra-operative infusions of secretin, a naturally occurring
hormone that stimulates bicarbonate release from the pancreas, following resection but just
prior to abdomen closure, may identify a leak if present. If secretin can demonstrate
evidence of leaking intra-operatively, the pancreatic duct leak may be able to be fixed prior
to abdominal closure. The investigators aim to determine if giving an intra-operative
infusion of secretin will allow for identification and treatment of leaks after pancreatic
reconstruction and prior to abdominal closure, leading to a reduction in the rate of
pancreatic anastomotic leaks requiring intervention. The investigators will perform a
double-blind, randomized pilot study of 176 patients undergoing pancreatic resection
(pancreaticoduodenectomy and distal pancreatectomy) at Dartmouth-Hitchcock Medical Center. 88
of those patients will receive an intra-operative secretin infusion prior to abdominal
closure and 88 will receive a saline placebo. Our primary outcome of interest will be the
rate of pancreas duct leaks in each group as measured by the amount of amylase present in the
surgical drains 5 days following surgery.
pancreatic anastomosis or repair has been referred to as the Achilles heel of pancreatic
surgery. Unfortunately, despite recognition of this problem and multiple operative techniques
proposed to prevent this complication, leaks continue to represent a major cause of morbidity
for patients undergoing pancreatic surgery. Treatment of leaks often requires nutritional
support with total parenteral nutrition to diminish the leak in addition to invasive
interventions to contain the leak with drains, stents or in severe cases, reoperation.
Experiential data suggest that intra-operative infusions of secretin, a naturally occurring
hormone that stimulates bicarbonate release from the pancreas, following resection but just
prior to abdomen closure, may identify a leak if present. If secretin can demonstrate
evidence of leaking intra-operatively, the pancreatic duct leak may be able to be fixed prior
to abdominal closure. The investigators aim to determine if giving an intra-operative
infusion of secretin will allow for identification and treatment of leaks after pancreatic
reconstruction and prior to abdominal closure, leading to a reduction in the rate of
pancreatic anastomotic leaks requiring intervention. The investigators will perform a
double-blind, randomized pilot study of 176 patients undergoing pancreatic resection
(pancreaticoduodenectomy and distal pancreatectomy) at Dartmouth-Hitchcock Medical Center. 88
of those patients will receive an intra-operative secretin infusion prior to abdominal
closure and 88 will receive a saline placebo. Our primary outcome of interest will be the
rate of pancreas duct leaks in each group as measured by the amount of amylase present in the
surgical drains 5 days following surgery.
We hypothesize that intra-operative, intravenous secretin administration will decrease the
rate of pancreatic leaks in patients undergoing pancreatic resection. Our primary objective
is to determine if intravenous secretin administration will decrease the amount of pancreatic
leaks as measured by drain fluid amylase 5 days following resection. Our secondary objectives
are to determine if intra-operative intravenous secretin administration changes the
management of the pancreatic resection margin intra-operatively or impacts length of stay
(LOS)
Use a level of detail similar to what would be used when submitting an article for
publication in a peer reviewed journal. Explain the study procedures, data collection, and
analysis process. Please define terms and explain concepts which might be confusing to
reviewers who are not expert in the area of the study. If a formal protocol for the study
exists, page references to the protocol are acceptable.
This study design is a prospective, double-blind, randomized-controlled trial. We will enroll
patients in our institution undergoing pancreatic resection to receive either 1) one dose
weight-based Secretin to be given once the closure of the pancreatic resection margin is
complete 2) saline placebo.
Consent and basic demographics will be garnered by the physician in an office visit once the
surgery has been scheduled and consent for the surgery is being obtained. The consent will be
validated by the treating surgeon in the pre-procedure area on the day of the surgery.
The patient will undergo the scheduled surgery. Once the pancreatic anastomosis has been
deemed acceptable by the attending physician, but prior to abdominal closure, the patient
will be randomized to receive either Secretin (0.2 mcg/kg) or saline placebo. The attending
surgeon will be blinded to this assignment.
10 minutes after receiving the Secretin or placebo, the attending surgeon will examine the
anastomosis or repaired cut edge of the pancreas to determine if leakage of pancreatic fluid
is noted, leak location(s), type (side branch/main duct) and whether any further intervention
was performed in an effort to close the leak. Specifics of operative intervention will be
documented. The patient will then undergo standard surgical closure of the abdomen.
As is standard of care at DHMC, surgical drains will be placed adjacent to the anastomosis
and drain amylase output will be checked on POD #1, POD#3 and POD#5. Pancreatic leak is
defined according to the International Study Group of Pancreatic Fistula (ISGPF) definition
as drainage of >50 cc/day of amylase-rich fluid (greater than a 3-fold elevation above the
upper limit of normal in serum) through the surgically placed drains on POD #5. Randomization
assignments will be revealed once the patient has been discharged from the hospital following
their initial surgical intervention. A follow-up visit with the patient two weeks following
discharge, will evaluate for any evidence of ongoing pancreatic duct leak.
The primary outcome of interest will be the presence of pancreatic leaks based on the amount
of drain amylase on POD#5. Secondary outcomes will include: 1) technical interventions
intra-operatively directed to leak closure or manipulation of the anastomosis following
Secretin or placebo stimulation 2) length of stay as a surrogate to complication severity
after pancreatic surgery.
Patient demographics, risk factors, operative technique, randomization assignment and outcome
data will be recorded on standard case report forms - See Case Report Forms in Appendix. Data
will be stored in an encrypted hard-drive by a single agent (Gardner) who is the only
researcher who has access to the randomization data.
rate of pancreatic leaks in patients undergoing pancreatic resection. Our primary objective
is to determine if intravenous secretin administration will decrease the amount of pancreatic
leaks as measured by drain fluid amylase 5 days following resection. Our secondary objectives
are to determine if intra-operative intravenous secretin administration changes the
management of the pancreatic resection margin intra-operatively or impacts length of stay
(LOS)
Use a level of detail similar to what would be used when submitting an article for
publication in a peer reviewed journal. Explain the study procedures, data collection, and
analysis process. Please define terms and explain concepts which might be confusing to
reviewers who are not expert in the area of the study. If a formal protocol for the study
exists, page references to the protocol are acceptable.
This study design is a prospective, double-blind, randomized-controlled trial. We will enroll
patients in our institution undergoing pancreatic resection to receive either 1) one dose
weight-based Secretin to be given once the closure of the pancreatic resection margin is
complete 2) saline placebo.
Consent and basic demographics will be garnered by the physician in an office visit once the
surgery has been scheduled and consent for the surgery is being obtained. The consent will be
validated by the treating surgeon in the pre-procedure area on the day of the surgery.
The patient will undergo the scheduled surgery. Once the pancreatic anastomosis has been
deemed acceptable by the attending physician, but prior to abdominal closure, the patient
will be randomized to receive either Secretin (0.2 mcg/kg) or saline placebo. The attending
surgeon will be blinded to this assignment.
10 minutes after receiving the Secretin or placebo, the attending surgeon will examine the
anastomosis or repaired cut edge of the pancreas to determine if leakage of pancreatic fluid
is noted, leak location(s), type (side branch/main duct) and whether any further intervention
was performed in an effort to close the leak. Specifics of operative intervention will be
documented. The patient will then undergo standard surgical closure of the abdomen.
As is standard of care at DHMC, surgical drains will be placed adjacent to the anastomosis
and drain amylase output will be checked on POD #1, POD#3 and POD#5. Pancreatic leak is
defined according to the International Study Group of Pancreatic Fistula (ISGPF) definition
as drainage of >50 cc/day of amylase-rich fluid (greater than a 3-fold elevation above the
upper limit of normal in serum) through the surgically placed drains on POD #5. Randomization
assignments will be revealed once the patient has been discharged from the hospital following
their initial surgical intervention. A follow-up visit with the patient two weeks following
discharge, will evaluate for any evidence of ongoing pancreatic duct leak.
The primary outcome of interest will be the presence of pancreatic leaks based on the amount
of drain amylase on POD#5. Secondary outcomes will include: 1) technical interventions
intra-operatively directed to leak closure or manipulation of the anastomosis following
Secretin or placebo stimulation 2) length of stay as a surrogate to complication severity
after pancreatic surgery.
Patient demographics, risk factors, operative technique, randomization assignment and outcome
data will be recorded on standard case report forms - See Case Report Forms in Appendix. Data
will be stored in an encrypted hard-drive by a single agent (Gardner) who is the only
researcher who has access to the randomization data.
Inclusion Criteria:
1. Scheduled for pancreatic surgery requiring pancreatic resection at DHMC
2. Age greater than 18 years old
3. Ability to provide written informed consent
Exclusion Criteria:
1. Inability to provide written informed consent
2. Current ongoing acute pancreatitis
3. Pregnant or nursing mothers
4. Any medical condition which in the judgment of the Investigator renders participation
in this study medically inadvisable.
5. Participation in an investigational clinical study for a drug or medical device within
30 days prior to Visit 1.
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