Patients Who Undergo Pancreatoduodenectomy Clinical Trial
| NCT number | NCT01898780 |
| Other study ID # | HOMING |
| Secondary ID | |
| Status | Enrolling by invitation |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | June 2013 |
| Verified date | October 2019 |
| Source | Wakayama Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.
| Status | Enrolling by invitation |
| Enrollment | 190 |
| Est. completion date | |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: Patients from whom we obtained written informed consent of this study Exclusion Criteria: - Patients with severe ischemic cardiac disease - Patients with severe liver damage - Patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis - Patients requiring dialysis treatment due to chronic renal failure - Patients who are considered as inappropriate by attending physician |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Second Department of Surgery, Wakayama Medical University | Wakayama |
| Lead Sponsor | Collaborator |
|---|---|
| Wakayama Medical University |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The frequency of pancreatic fistula including ISGPF grade B and C | Ninety days after operation | ||
| Secondary | The rates of postoperative complications | Ninety days after operation |