Enteral and Parenteral Nutrition in the Conservative Treatment for gastrectomy related Pancreatic Fistula: A Randomized Clinical Trial

Enteral and Parenteral Nutrition in the Conservative Treatment for gastrectomy related Pancreatic Fistula: A Randomized Clinical Trial - EN vs PN in the treatment of POPF: A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018353

Enrollment

Registered

2015-07-20

Start date

2014-09-11

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

gastrectomy related Pancreatic Fistula

Interventions

Patients will be random allocated for enteral nutrition(EN) group or parenteral nutrition(PN) group. Patients who are in EN group will be inserted nasal feeding tube and feeded, and other patients wh

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gastric cancer has been diagnosed by pathological findings. Post-gastrectomy (R0 or R1 resection) within 3-7 postoperative days (POD). The case has been inserted drain into the abdominal cavity. The laboratory data of amylase for drain discharge after 3POD and within 1day of enrollment must be more than three times higher limit of serum amylase. The case has been diagnosed without anastomotic leakage by CT scan or X-Ray. Laboratory data within 3days before enrollment must be fulfilled as follows. WBC >=3000/mm3 Hb>=8.0g/dL Plt >=100000/mm3 T-bil<=2.0mg/dL AST<150IU/L ALT<150IU/L Creatinine<=1.5 mg/dL The case has never received radiotherapy for their abdominal cavity including other cancers. The case signed informed consent.

Exclusion criteria

Exclusion criteria: The case with another malignant tumors. The case are in the catecholamine-dependent shock stage. The case are pregnant or potentially pregnant. The doctors define as inappropriate because of severe psychosis or psychological symptom. The case has been systemic administered steroids continually. The case has poorly-controlled hypertension. The case has continually administered insulin or poor-controlled diabetes mellitus. The case has ventilator-dependent respiratory complications.

Design outcomes

Primary

Measure	Time frame
The cure rate of pancreatic fistula within 30 postoperative day.	—

Secondary

Measure	Time frame
The disease duration of pancreatic fistula. The rate of drain removal within 30 postoperative day. The period of postoperative hospitalization. Nutritional index during the study(body weight, serum albumin, total serum albumin, total serum cholesterol, lymphocyte count) The incidence of adverse effect	—

Countries

Japan

Contacts

Public ContactShuji Takiguchi

Osaka University, Graduate School of Medicine Gastroenterological Surgery

stakiguchi@gesurg.med.osaka-u.ac.jp+81-6-6879-3251

Outcome results

None listed

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