Novel self-assembling peptide gel CK2-085-SP (SPG-178) as a sealant for preventing postoperative pancreatic fistula after pancreatic resection: a study protocol for a prospective, exploratory, investigator-initiated clinical trial (PepSeal-001).
- 1Department of Gastroenterological Surgery, Graduate School of Medicine, The University of Osaka, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan.
- 2Department of Medical Innovation, The University of Osaka Hospital, Suita, Japan.
- 3Department of Gastroenterological Surgery, Graduate School of Medicine, The University of Osaka, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan. [email protected].
Abstract
Background
Postoperative pancreatic fistula (POPF) remains a critical complication following pancreatic resection. Standard fibrin sealants are frequently degraded by pancreatic proteases, limiting their efficacy, which is hypothesized to be due to rapid degradation by proteolytic enzymes in pancreatic juice. CK2-085-SP is a novel, synthetic self-assembling peptide (SPG-178) gel that retains its structural integrity in pancreatic juice, potentially providing more robust sealing than conventional biological sealants. We designed this exploratory, investigator-initiated trial to evaluate the safety and feasibility of CK2-085-SP. This study represents the first-in-human clinical application of the self-assembling peptide gel for pancreatic resection.Methods
This is a prospective, single-arm clinical trial (PepSeal-001) for which the Clinical Trial Notification has been accepted by the Pharmaceuticals and Medical Devices Agency. A total of 25 patients will be enrolled to ensure that CK2-085-SP is applied to at least 10 patients undergoing pancreaticoduodenectomy and 10 patients undergoing distal pancreatectomy. To ensure the evaluation of the device in high-risk cases, the study aims to include at least seven patients undergoing pancreaticoduodenectomy with a main pancreatic duct diameter ≤ 3 mm. The primary endpoints are the incidence and severity of adverse events and device malfunctions within 90 days postoperatively. Secondary endpoints include amylase levels in drainage fluid; the incidence of clinically relevant POPF; incidence of intra-abdominal abscess, delayed gastric emptying, postoperative hemorrhage, drainage tube reinsertion, reoperation, readmission, and postoperative mortality; duration of drain placement; length of postoperative hospital stay; and usability of the study device.Discussion
The PepSeal-001 trial will evaluate the safety and feasibility of CK2-085-SP in pancreaticoduodenectomy and distal pancreatectomy. This study is expected to provide clinical evidence for the development of a novel synthetic peptide-based sealant to improve outcomes in pancreatectomy.
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BibTeX
@article{tomimaru2026novel,
title = {{Novel self-assembling peptide gel CK2-085-SP (SPG-178) as a sealant for preventing postoperative pancreatic fistula after pancreatic resection: a study protocol for a prospective, exploratory, investigator-initiated clinical trial (PepSeal-001).}},
author = {Yoshito Tomimaru and Satoshi Shigeno and Kenji Shirakura and Airi Harada and Takuro Takeuchi and Tsukasa Taguchi and Yosuke Mukai and Kazuki Sasaki and Shinichiro Hasegawa and Daisaku Yamada and Takehiro Noda and Hirofumi Akita and Tomomi Yamada and Hidetoshi Eguchi},
journal = {BMC surgery},
year = {2026},
month = jul,
doi = {10.1186/s12893-026-04096-4},
url = {https://europepmc.org/article/MED/42928181},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Novel self-assembling peptide gel CK2-085-SP (SPG-178) as a sealant for preventing postoperative pancreatic fistula after pancreatic resection: a study protocol for a prospective, exploratory, investigator-initiated clinical trial (PepSeal-001).
AU - Yoshito Tomimaru
AU - Satoshi Shigeno
AU - Kenji Shirakura
AU - Airi Harada
AU - Takuro Takeuchi
AU - Tsukasa Taguchi
AU - Yosuke Mukai
AU - Kazuki Sasaki
AU - Shinichiro Hasegawa
AU - Daisaku Yamada
AU - Takehiro Noda
AU - Hirofumi Akita
AU - Tomomi Yamada
AU - Hidetoshi Eguchi
PY - 2026
DA - 2026/07/29
JO - BMC surgery
DO - 10.1186/s12893-026-04096-4
UR - https://europepmc.org/article/MED/42928181
AB - Background Postoperative pancreatic fistula (POPF) remains a critical complication following pancreatic resection. Standard fibrin sealants are frequently degraded by pancreatic proteases, limiting their efficacy, which is hypothesized to be due to rapid degradation by proteolytic enzymes in pancreatic juice. CK2-085-SP is a novel, synthetic self-assembling peptide (SPG-178) gel that retains its structural integrity in pancreatic juice, potentially providing more robust sealing than conventional biological sealants. We designed this exploratory, investigator-initiated trial to evaluate the safety and feasibility of CK2-085-SP. This study represents the first-in-human clinical application of the self-assembling peptide gel for pancreatic resection.Methods This is a prospective, single-arm clinical trial (PepSeal-001) for which the Clinical Trial Notification has been accepted by the Pharmaceuticals and Medical Devices Agency. A total of 25 patients will be enrolled to ensure that CK2-085-SP is applied to at least 10 patients undergoing pancreaticoduodenectomy and 10 patients undergoing distal pancreatectomy. To ensure the evaluation of the device in high-risk cases, the study aims to include at least seven patients undergoing pancreaticoduodenectomy with a main pancreatic duct diameter ≤ 3 mm. The primary endpoints are the incidence and severity of adverse events and device malfunctions within 90 days postoperatively. Secondary endpoints include amylase levels in drainage fluid; the incidence of clinically relevant POPF; incidence of intra-abdominal abscess, delayed gastric emptying, postoperative hemorrhage, drainage tube reinsertion, reoperation, readmission, and postoperative mortality; duration of drain placement; length of postoperative hospital stay; and usability of the study device.Discussion The PepSeal-001 trial will evaluate the safety and feasibility of CK2-085-SP in pancreaticoduodenectomy and distal pancreatectomy. This study is expected to provide clinical evidence for the development of a novel synthetic peptide-based sealant to improve outcomes in pancreatectomy.
SN - 1471-2482
ER -