Lanreotide for the prevention of postoperative pancreatic fistula (S2408): study protocol for a multicenter randomized controlled trial.
17 affiliations
- 1University of Washington Department of Surgery, Seattle, WA, USA.
- 2Fred Hutchinson Cancer Center, Seattle, WA, USA.
- 3SWOG Statistics & Data Management Center, Seattle, WA, USA.
- 4Network Operations Center, SWOG Cancer Research Network, San Antonio, TX, USA.
- 5Division of Patient Advocacy, SWOG Cancer Research Network, San Antonio, TX, USA.
- 6Cancer Research Consortium of West Michigan NCORP, Grand Rapids, MI, USA.
- 7City of Hope National Medical Center, Duarte, CA, USA.
- 8University of Cincinnati Department of Surgery, Cincinnati, OH, USA.
- 9Division of Surgical Oncology, Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
- 10Henry Ford Cancer Institute, Detroit, MI, USA.
- 11Northwestern University Department of Surgery, Chicago, IL, USA.
- 12Wake Forest University School of Medicine, Winston-Salem, NC, USA.
- 13University of Toronto Department of Surgery, Toronto, ON, Canada.
- 14University of Pennsylvania Department of Surgery, Philadelphia, PA, USA.
- 15University of Washington Department of Surgery, Seattle, WA, USA. [email protected].
- 16Fred Hutchinson Cancer Center, Seattle, WA, USA. [email protected].
- 17Surgical Outcomes Research Center, University of Washington, Seattle, WA, USA. [email protected].
Abstract
Background
Postoperative pancreatic fistula (POPF) remains the defining complication of pancreatectomy, leading to significant morbidity, mortality, and increased healthcare costs. Multiple studied interventions have failed to meaningfully reduce the incidence of POPF, which is estimated to affect 25-30% of distal pancreatectomy patients. Since the early 1990s, studies have explored the role of perioperative somatostatin analogs (SSAs) for POPF prophylaxis, including octreotide. A randomized trial of perioperative pasireotide reported a reduced incidence of POPF, but faced criticism due to its single-center design, inconvenient dosing regimen, and pasireotide's high rate of dose-limiting side effects. Lanreotide is a more recently developed SSA with a simpler dosing regimen due to its depot formulation and a favorable side-effects profile that has been proposed for POPF prophylaxis. In a single-arm phase II trial, a single dose of preoperative lanreotide was associated with low POPF rates of 11% and 3% in patients undergoing pancreaticoduodenectomy (PD) and distal pancreatectomy (DP), respectively.Methods
S2408 is a multicenter, phase III randomized controlled trial sponsored by the National Cancer Institute Division of Cancer Prevention comparing the incidence of POPF in participants receiving a single dose of preoperative lanreotide (120 mg subcutaneous) versus saline placebo immediately prior to DP for suspected or biopsy-proven pancreatic malignancy. Planned enrollment of 274 participants will take place at academic and community hospitals in North America. The primary objective is to compare the incidence of POPF within 60 days after surgery between treatment groups. Secondary objectives include comparing the incidences of other postoperative sequelae (biochemical leak, delayed gastric emptying, post-pancreatectomy hemorrhage) within 60 days of surgery, postoperative length of hospital stay, and changes from baseline in cancer-specific quality of life between treatment groups. Blood, drain fluid, and tissue specimens will be banked for future correlative studies.Discussion
S2408 is a multicenter clinical trial designed to evaluate the hypothesis that a single dose of preoperative lanreotide will reduce the incidence of POPF in patients undergoing DP compared to placebo.Trial registration
ClinicalTrials.gov NCT06807437. Registered on February 2, 2025. Trial opened for accrual February 14, 2025. URL: https://clinicaltrials.gov/study/NCT06807437 .
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BibTeX
@article{intara2026lanreotide,
title = {{Lanreotide for the prevention of postoperative pancreatic fistula (S2408): study protocol for a multicenter randomized controlled trial.}},
author = {Anna S Intara and Katherine A Guthrie and Sardar Shahmir B Chauhan and Kathryn B Arnold and Roxanne Topacio and Kimberly Carvalho and Andrea Garcia and Valerie Fraser and Gerald Paul Wright and Virginia Sun and Syed A Ahmad and Flavio G Rocha and E Gabriela Chiorean and Philip Philip and Brett L Ecker and Bradley N Reames and Paul Karanicolas and Robert S Krouse and Venu G Pillarisetty and Jonathan G Sham},
journal = {Trials},
year = {2026},
month = aug,
doi = {10.1186/s13063-026-09933-8},
url = {https://europepmc.org/article/MED/42958416},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Lanreotide for the prevention of postoperative pancreatic fistula (S2408): study protocol for a multicenter randomized controlled trial.
AU - Anna S Intara
AU - Katherine A Guthrie
AU - Sardar Shahmir B Chauhan
AU - Kathryn B Arnold
AU - Roxanne Topacio
AU - Kimberly Carvalho
AU - Andrea Garcia
AU - Valerie Fraser
AU - Gerald Paul Wright
AU - Virginia Sun
AU - Syed A Ahmad
AU - Flavio G Rocha
AU - E Gabriela Chiorean
AU - Philip Philip
AU - Brett L Ecker
AU - Bradley N Reames
AU - Paul Karanicolas
AU - Robert S Krouse
AU - Venu G Pillarisetty
AU - Jonathan G Sham
PY - 2026
DA - 2026/08/03
JO - Trials
DO - 10.1186/s13063-026-09933-8
UR - https://europepmc.org/article/MED/42958416
AB - Background Postoperative pancreatic fistula (POPF) remains the defining complication of pancreatectomy, leading to significant morbidity, mortality, and increased healthcare costs. Multiple studied interventions have failed to meaningfully reduce the incidence of POPF, which is estimated to affect 25-30% of distal pancreatectomy patients. Since the early 1990s, studies have explored the role of perioperative somatostatin analogs (SSAs) for POPF prophylaxis, including octreotide. A randomized trial of perioperative pasireotide reported a reduced incidence of POPF, but faced criticism due to its single-center design, inconvenient dosing regimen, and pasireotide's high rate of dose-limiting side effects. Lanreotide is a more recently developed SSA with a simpler dosing regimen due to its depot formulation and a favorable side-effects profile that has been proposed for POPF prophylaxis. In a single-arm phase II trial, a single dose of preoperative lanreotide was associated with low POPF rates of 11% and 3% in patients undergoing pancreaticoduodenectomy (PD) and distal pancreatectomy (DP), respectively.Methods S2408 is a multicenter, phase III randomized controlled trial sponsored by the National Cancer Institute Division of Cancer Prevention comparing the incidence of POPF in participants receiving a single dose of preoperative lanreotide (120 mg subcutaneous) versus saline placebo immediately prior to DP for suspected or biopsy-proven pancreatic malignancy. Planned enrollment of 274 participants will take place at academic and community hospitals in North America. The primary objective is to compare the incidence of POPF within 60 days after surgery between treatment groups. Secondary objectives include comparing the incidences of other postoperative sequelae (biochemical leak, delayed gastric emptying, post-pancreatectomy hemorrhage) within 60 days of surgery, postoperative length of hospital stay, and changes from baseline in cancer-specific quality of life between treatment groups. Blood, drain fluid, and tissue specimens will be banked for future correlative studies.Discussion S2408 is a multicenter clinical trial designed to evaluate the hypothesis that a single dose of preoperative lanreotide will reduce the incidence of POPF in patients undergoing DP compared to placebo.Trial registration ClinicalTrials.gov NCT06807437. Registered on February 2, 2025. Trial opened for accrual February 14, 2025. URL: https://clinicaltrials.gov/study/NCT06807437 .
SN - 1745-6215
ER -