Trial · Interventional
RecruitingPhase 3Registry dataLanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 274 participants (estimated)
- Sponsor
- SWOG Cancer Research Network · Network
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- 9 May 2025
- Primary completion
- 1 Nov 2027 (estimated)
- Completion
- 1 Nov 2027 (estimated)
- First posted
- 4 Feb 2025
- Last update posted
- 31 Mar 2026
- Conditions
- Pancreatic Carcinoma · Pancreatic Neoplasm
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
NCT068074379 May 2025 to est. 1 Nov 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Biospecimen CollectionProcedure
- Distal PancreatectomyProcedure
- LanreotideDrug
- Questionnaire AdministrationOther
- SalineOther
Arms2
Experimental
Arm I (lanreotide, distal pancreatectomy)
Patients receive lanreotide SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and on post-operative days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.
Placebo comparator
Arm II (saline placebo, distal pancreatectomy)
Patients receive saline placebo SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and post-operatively on days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.
Primary outcomes1
Outcomes the sponsor listed as primary.
Incidence of postoperative pancreatic fistula (POPF)
Time frame · Up to 60 days after distal pancreatectomy
Registry description
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.
Secondary outcomes(3)
Incidence of biochemical leak (BL)
Time frame · Up to 60 days after distal pancreatectomy
Registry description
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.
Number of post-operation hospital days
Time frame · From the time of surgery up to 60 days after distal pancreatectomy
Registry description
Mean hospital length of stay will be compared according to treatment arm via linear regression model with adjustment for stratification factor.
Change in overall quality of life (QOL)
Time frame · At baseline and at 14 and 60 days after surgery
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.