Omission of prophylactic intra-abdominal drainage after pancreatoduodenectomy: a prospective pilot safety study of a no-drain strategy

A prospective single-arm pilot study evaluating the safety of omitting prophylactic intra-abdominal drainage after pancreatoduodenectomy - PD No-Drain Safety Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061526

Enrollment

Registered

2026-05-20

Start date

2026-05-20

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

Pancreatic cancer

Interventions

In low-risk patients for postoperative pancreatic fistula, a no-drain strategy will be applied during pancreatoduodenectomy by omitting prophylactic intra-abdominal drainage. Postoperative management

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 20 to 85 years at the time of informed consent Patients with a main pancreatic duct diameter of 3 mm or greater on preoperative computed tomography Patients judged intraoperatively to have a hard pancreatic texture by surgical palpation Patients with an Acinar Score of 3 or greater at the pancreatic transection margin Patients who have received sufficient explanation about the study, fully understood its contents, and provided written informed consent voluntarily

Exclusion criteria

Exclusion criteria: Patients with distant metastasis Patients with an operative time exceeding 8.5 hours Patients with intraoperative blood loss exceeding 500 mL Patients requiring concomitant vascular resection Patients undergoing pancreatoduodenectomy for diseases other than pancreatic cancer Patients judged by the principal investigator or subinvestigators to be unsuitable for participation in the study Eligible patients are defined as those who meet all inclusion criteria and do not meet any of the exclusion criteria listed above.

Design outcomes

Primary

Measure	Time frame
Rate of invasive reintervention within 30 days after surgery Invasive reintervention is defined as percutaneous drainage, reoperation, or interventional radiology performed for postoperative complications within 30 days after surgery.	—

Secondary

Measure	Time frame
ClavienDindo gradeIII or higher complications, positive ascites culture before abdominal closure, overall morbidity, 30-day mortality, CR-POPF, infectious complications, pleural effusion/ascites, reintervention-related outcomes, CT-related outcomes, postpancreatectomy hemorrhage, bile leakage, delayed gastric emptying, length of stay, antibiotic use, postoperative pain, and diuretic use.	—

Countries

Japan

Contacts

Public ContactShoichi Irie

Juntendo University Graduate School of Medicine Department of Hepatobiliary-Pancreatic Surgery

s.irie.fo@juntendo.ac.jp0338133111

Outcome results

None listed

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