Safety of stapler vs. non-stapler closure of the pancreatic remnant after distal pancreatectomy: a multicenter randomized controlled trial

Safety of stapler vs. non-stapler closure of the pancreatic remnant after distal pancreatectomy: a multicenter randomized controlled trial - SNS-RCT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004838

Enrollment

140

Registered

2011-01-18

Start date

2011-01-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign and malignant pancreatic neoplasms indicated for distal pancreatectomy

Interventions

Non-stapler closure: After mobilazation of the pancreatic body, the transection is performed with paen fracture method, surgical scalpel, or harmonic scalpel. After a ligation of the pancreatic duct,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Non-malignant or malignant pancreatic neoplasms indicated for distal pancreatectomy 2)Expected survival time more than 3 months 3)Open distal pancreatectomy is feasible 4)ECOG performance status <3 5)No functinal disturvance of each organ 6)Age >=20, <90 7)Confirmation ofinformed consent

Exclusion criteria

Exclusion criteria: 1)Chemotherapy, immunotherapy, or radiotherapy before operation 2)Possibility of total pancreaterctomy, or combined celiac artery resection 3)Severe comorbid illness needing postoperative care under ICU 4)Severe psychiatric or neurologic diseases 5)Pregnancy 6)Lack fo compliance

Design outcomes

Primary

Measure	Time frame
Clinical pancreatic fistul rate	—

Secondary

Measure	Time frame
Operative time, bleeding, chemical pancreatic fistula rate, duration of drain placement, complications, duration of hospital stay, severe complication rate	—

Countries

Japan

Contacts

Public ContactKazuaki Shimada

National Cancer Center Hospital Hepatobiliary and pancreatic surgery division

kshimada@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026