An interventional study of Modified Blumgart suture method and Three-sided mattress suture in Postoperative Pancreatic Fistula Post-pancreatoduodenectomy, sponsored by Tokai University. Enrolling by invitation at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Tokai University · Not applicable, Interventional, and Treatment
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In pancreaticojejunostomy following pancreaticoduodenectomy for soft pancreas, a randomized controlled trial will be conducted to compare a patient group using the conventional Blumgart modified technique and a patient group in which mattress sutures are added to the cranial and caudal sides of the pancreaticojejunostomy after the Blumgart modified technique (three-sided mattress suture technique), and to evaluate the safety and usefulness of the three-sided mattress suture technique by comparing the incidence of pancreatic fistula (ISGPF grade B or C).
Pancreatoduodenectomy (PD) is one of the most difficult and invasive surgeries, with a 30-50% complication rate even at high volume centers. In particular, if a postoperative pancreatic fistula (POPF), a failure of the pancreaticojejunostomy (PJ) suture, occurs, pancreatic juice containing powerful digestive enzymes leaks into the abdominal cavity, which can develop into serious complications such as intraperitoneal abscesses and postpancreatectomy hemorrhage. To reduce the incidence of POPF post-PD, many clinical studies have been reported on PJ methods. Currently, the original/modified Blumgart method is widely used as an anastomosis technique with relatively good results, but the incidence of International Study Group for Pancreatic Surgery (ISGPS) criteria grade B/C is still around 10-20%. In particular, the incidence of POPF grade B/C in normal soft pancreases with preserved pancreatic function is high at approximately 20-40%, and it is known to be a higher risk than the atrophied, sclerosing pancreas after pancreatitis (incidence rate of approximately 0-10%), and there is still room for improvement in the PJ technique. Therefore, the current clinical problem to be solved in PD is "PJ for the soft pancreas," and reducing the incidence of POPF is thought to be extremely beneficial for patients.
In recent years, it has been reported that the incidence of pseudoaneurysm increases significantly when POPF is found on the superior side of the PJ, and that the incidence of deep surgical site infection increases when POPF occurs on the inferior side of the anastomosis. In the Blumgart method, ventral and dorsal sides of the pancreatic stump are covered by the jejunal wall, but a weak point remains where the jejunal wall does not completely cover the superior and inferior sides of the PJ anastomosis. Therefore, the investigators created a three-sided mattress suture method to eliminate weak gaps by adding mattress sutures between the pancreas and jejunum on the superior and inferior sides of the PJ anastomosis to reduce the incidence of grades B/C POPF.
Prior to this study, the investigators conducted a pilot study in which a three-sided mattress suture was performed for PJ following pylorus-resecting PD in 10 consecutive patients with soft pancreases, and no case of POPF ISGPF grade B/C was observed (incidence rate 0%). The Three-sided mattress method is original, and no randomized controlled trial has proven that this novel method contributes to improving the incidence of POPF post-PD. In this study, the investigators conducted a randomized controlled phase II trial comparing the three-sided mattress suture method with the conventional modified Blumgart suture method, with the aim of proving the effectiveness of this original suture method by examining the incidence of POPF grade B/C. If the usefulness of the three-sided mattress suture method is proven in this study, it is expected to have a major impact as a safer PJ method in PD.
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 80 is below the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.
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Procedure: Modified Blumgart suture method
Procedure: Three-sided mattress suture
During pancreaticoduodenectomy, the modified Blumgart suture method is used for pancreaticojejunostomy. For anastomosis, 5-0PDS is used for pancreatic duct mucosal anastomosis, and 3-0 or 4-0 monofilament non-absorbable suture is used for pancreaticojejunal mattress anastomosis.
At the time of pancreaticoduodenectomy, the three-sided mattress suture is used as the pancreaticojejunostomy method. In addition to the conventional Blumgart modified suture, the three-sided mattress suture method adds a mattress anastomosis with 3-0 or 4-0 monofilament non-absorbable suture to the cranial and caudal sides of the pancreaticojejunostomy site.
Incidence of pancreatic fistula ISGPF grade B or C
Time frame: Up to 90 days after surgery
Incidence of postoperative complications, incidence of remnant pancreatitis
Time frame: Up to 90 days after surgery
Plan to share: Undecided
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Started Dec 2024 (actual). Primary completion is estimated for Dec 2029, 60 months after the start.
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Tokai University