Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial

Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial - SH-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005463

Enrollment

100

Registered

2011-04-19

Start date

2011-04-01

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

Peirampullary tumor

Interventions

Intervention is stapled anastomosis using circular stapler on duodeno-jejunostomy after pancreaticoduodenectomy Control arm is hand-sewn anastomosis on duodeno-jejunostomy after pancreaticoduodenectom

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: On the diagnosis of periampullary malignancy, benign tumor or inflammatory disease, the patient is going to undergo pylorus-preserving pancreaticoduodenectomy with duodeno-jejunostomy

Exclusion criteria

Exclusion criteria: 1) patients undergoing total pancreatectomy 2) patients who has undergone gastric bypass or gastrectomy 3) patients undergoing pancreaticoduodenectomy plus hemihepatectomy

Design outcomes

Primary

Measure	Time frame
Incidence of delayed gastric emptying defined by ISGPS	—

Secondary

Measure	Time frame
reconstruction time, findings on upper gastrography on day 4-7, incidence of pancreatic fistula, incidence of complication, hospital stay, rate of body weight loss	—

Countries

Japan

Contacts

Public ContactYoji Kishi

National Cancer Center Hospital Hepatobiliary and Pancreatic Surgery Division

yokishi@ncc.go.jp03-3542-2511

Outcome results

None listed

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