Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network
About this trial
This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential
Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date
Participants must not have a known history of a prior diagnosis of malabsorption syndrome
Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample and pancreas fluid collection
Distal Pancreatectomy
Procedure/SurgeryUndergo distal pancreatectomy
Lanreotide
DrugGiven SC
Questionnaire Administration
Other interventionAncillary studies
Saline
Other interventionGiven SC
Treatment groups
274 Participants
are divided into 2 treatment groupsGroup A: Arm I (lanreotide, distal pancreatectomy)Experimental treatment 4 interventions
Group B: Arm II (saline placebo, distal pancreatectomy)Placebo comparator 4 interventions
Trial outcomes
Primary outcomes
1
Incidence of postoperative pancreatic fistula (POPF)
POPF will be assessed using the 2016 International Study Group for Pancreas Surgery (ISGPS). Incidence rates of POPF in each treatment arm will be described, and treatment arm differences assessed via logistic regression model with adjustment for stratification factor.
Time frame
Up to 60 days after distal pancreatectomySecondary outcomes
1
Incidence of biochemical leak (BL)
BL will be defined by the ISGPS as a peritoneal drain amylase greater than three times the upper limit of the institutional normal serum amylase without an effect on clinical management or duration of hospital stay. BL will only be measured in those who had a peritoneal drain placed. Treatment arm differences will be assessed via logistic regression model with adjustment for stratification factor.
Time frame
Up to 60 days after distal pancreatectomy2
Number of post-operation hospital days
Mean hospital length of stay will be compared according to treatment arm via linear regression model with adjustment for stratification factor.
Time frame
From the time of surgery up to 60 days after distal pancreatectomy3
Change in overall quality of life (QOL)
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Core 30 (C30). Treatment arm differences in EORTC QLQ-C30 changes will be assessed by repeated measures linear regression model as a function of randomization assignment, baseline score, stratification factor, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures.
Time frame
At baseline and at 14 and 60 days after surgeryOther outcomes
1
Changes in pancreatic specific QOL
Will be assessed using EORTC QLQ- Pancreatic Cancer 26. Treatment arm differences in changes from baseline will be assessed by repeated measures linear regression model as a function of randomization assignment, baseline score, stratification factor, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures.
Time frame
At baseline and up to 60 days after distal pancreatectomy2
Change in health-related QOL
Will be assessed using the European Quality of Life Five Dimension Five Level scale. Treatment arm differences in changes from baseline will be assessed by repeated measures linear regression model as a function of randomization assignment, baseline score, stratification factor, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures.
Time frame
At baseline and up to 60 days after distal pancreatectomy3
Delayed gastric emptying (DGE)
DGE will be defined by the ISGPS as reinsertion or persistence of a nasogastric tube after postoperative day (POD) 3 or inability to tolerate solid oral intake by POD 7. Treatment arm differences in the proportion of participants with DGE will be assessed via logistic regression model with adjustment for stratification factor.
Time frame
Up to 60 days after distal pancreatectomy4
Incidence of grades B/C post-pancreatectomy hemorrhage (PPH)
PPH will be defined by the ISGPS as postoperative intra- or extra-luminal hemorrhage requiring transfusion of fluid or blood, intensive care unit transfer, therapeutic endoscopy, endovascular embolization, or reoperation. Treatment arm differences in the proportion of participants with PPH will be assessed via logistic regression model with adjustment for stratification factor.
Time frame
Up to 60 days after distal pancreatectomySponsors and contacts
Click on the lead sponsor to view all of their trials.
SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov