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Search / Trial NCT06855888

Comparison of Three-sided and Single-sided Mattress Pancreaticojejunostomy in Pancreatoduodenectomy

Launched by TOKAI UNIVERSITY · Mar 3, 2025

Trial Information

Current as of June 27, 2025

Enrolling by invitation

Keywords

Mattress Suture Pancreaticojejunostomy Pancreatoduodenectomy Postoperative Pancreatic Fistula

ClinConnect Summary

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 Bl...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients scheduled for pancreaticoduodenectomy who have been determined to have a soft pancreas.
  • 2. Preoperative CT images show that the pancreatic duct diameter at the planned site of pancreatic resection is 5mm or less.
  • 3. ECOG Performance Status (PS) is 0-1.
  • 4. Age 18 years or older.
  • 5. Function of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) is maintained.
  • 6. Patients have sufficient judgment to understand the content of the research, and written consent has been obtained from the individual.
  • Exclusion Criteria:
  • 1. Patients with severe ischemic heart disease
  • 2. Patients with liver cirrhosis or active hepatitis
  • 3. Patients with respiratory distress requiring oxygen due to interstitial pneumonia or pulmonary fibrosis
  • 4. Patients undergoing dialysis due to chronic renal failure
  • 5. Patients requiring combined resection of surrounding organs
  • 6. Patients requiring arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc.
  • 7. Patients with active duplicate cancers that may affect adverse events or overall survival
  • 8. Patients taking oral steroids for a long period that may affect adverse events
  • 9. Patients with insufficient decision-making ability
  • 10. Other subjects deemed inappropriate by the principal investigator or investigator

About Tokai University

Tokai University is a leading academic institution in Japan, committed to advancing medical research and education. Renowned for its innovative approach to healthcare, Tokai University conducts clinical trials aimed at enhancing patient outcomes through evidence-based practices. The university's dedicated research teams collaborate with healthcare professionals to explore novel therapeutic interventions, ensuring rigorous adherence to ethical standards and regulatory guidelines. With a focus on translating scientific discoveries into clinical applications, Tokai University plays a pivotal role in shaping the future of medicine and improving the health of communities both locally and globally.

Locations

Isehara Shi, Kanagawa Ken, Japan

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported