Efficacy of Polyglycolic Acid Sheet on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer

A Multicenter Randomized Phase II trial Investigating The Effect of Polyglycolic Acid Sheet for Prevention of Pancreatic Fistula After Gastrectomy with Prophylactic Lymph Node Dissection

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042210090

Enrollment

320

Registered

2021-10-28

Start date

2022-02-03

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

gastric cancer, gastric neuroendocrine tumor gastric cancer, neuroendocrine tumor in stomach

Interventions

usage of Polyglycolic Acid Sheet in gastrectomy

Polyglycolic Acid Sheet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who were planned to undergo curative gastrectomy with D1+ or more lymp node dissection. Aged 20 years or mroe at the time of registration and written informed consent.

Exclusion criteria

Exclusion criteria: History of gastrectomy. History of pancreatectomy. Active infection in abdominal cavity. Tumor invasion to pancreas. Patients who were planned pancreatectomy. Patients who were planned splenectomy. Emergency surgery. Patients who were suspected to have allergy to polyglycolic acid. Patients who were planned robotic assisted gastrectomy. Ineligible for the study at the physician's assessment.

Design outcomes

Primary

Measure	Time frame
The maximum value of amylases of drain discharge	—

Secondary

Measure	Time frame
Ttransition of value of amylases of drain discharge Iincidence of pancreatic fistula Incidence of intra-abdominal abscess White blood cell count Value of C-reactive protein (CRP) Incidence of postoperative complication Duration of antibiotic agents administration Duration of abdominal drainage Usage of octreotide Duration of hospital stay. Incidence of bleeding in abdominal cavity Mortality Incidence of reoperation	—

Measure

Time frame

Ttransition of value of amylases of drain discharge Iincidence of pancreatic fistula Incidence of intra-abdominal abscess White blood cell count Value of C-reactive protein (CRP) Incidence of postoperative complication Duration of antibiotic agents administration Duration of abdominal drainage Usage of octreotide Duration of hospital stay. Incidence of bleeding in abdominal cavity Mortality Incidence of reoperation

—

Contacts

Public ContactDai Shimizu

Nagoya University Hospital

d-shimizu@med.nagoy-u.ac.jp+81-52-744-2250

Outcome results

None listed

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