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)

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. 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. 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.