Trial record 19 of 96 for:
Open Studies | "Fistula"
Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy
This study is currently recruiting participants.
Verified March 2013 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01550406
First received: November 21, 2011
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
To date, there has been many methods suggested to reduce pancreatic fistula. But there are no evidence of superiority to the other methods. This study is a multicenter prospective randomized phase III study of use of Tachocomb or Polyethylene Glycolic Acid (PGA) to prevent of pancreatic fistula after distal pancreatectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Fistula |
Device: Tachocomb Device: Polyglycolic acid (PGA) (Neoveil) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy: Prospective Multicenter Randomized Study |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- The rate of pancreatic fistula between groups [ Time Frame: postoperative 3rd day ] [ Designated as safety issue: No ]Pancreatic fistula was defined by criterion of ISGPF, Output through an operatively placed drain or a subsequently placed percutaneous drain, of any measurable volume of drain fluid on or after postoperative day 3, with an amylase content greater than three times the upper normal serum value
Secondary Outcome Measures:
- Surgery-related risk factor [ Time Frame: intraoperative time ] [ Designated as safety issue: No ]Amount of intraoperative bleeding, blood transfusion, operative time, operative method with open, laparoscopic, or robotic surgery
- disease- associated factors [ Time Frame: intraoperative time, within 1 day after operation ] [ Designated as safety issue: No ]pancreatic hardness, pathological findings, diameter of main p- duct, and the thickness of pancreas resection area
- patient-related risk factors analysis [ Time Frame: 1 week before the operation ] [ Designated as safety issue: No ]age, sex, race, comorbidity
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tachocomb
Tachocomb will be applicated on the cut surface of distal pancreatectomy
|
Device: Tachocomb
A kind of Mesh: ready-to-use hemostatic agent consisting of a collagen sheet coated on one side with human fibrinogen, bovine thrombin, and bovine aprotinin |
|
Active Comparator: PGA
PGA will be applicated on the cut surface of distal pancreatectomy
|
Device: Polyglycolic acid (PGA) (Neoveil)
Polyglycolide or Polyglycolic acid (PGA) is a biodegradable, thermoplastic polymer and the simplest linear, aliphatic polyester.
Other Name: Neoveil
|
|
No Intervention: Control
No mesh will be applicated on the cut surface of distal pancreatectomy
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 20 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Expected survival time more than 12 months
Patients with at least one of the following pathologic diseases scheduled for elective resection
- Resectable malignancies of the pancreatic body/ tail
- Resectable pre-malignant lesions of the pancreatic body/ tail
- Resectable benign lesion of the pancreatic body/ tail
Exclusion Criteria:
- Current immunosuppressive therapy
- Pancreatic atrophy or calcification due to severe pancreatitis
- Chemotherapy or radiotherapy before operation
- Severe psychiatric or neurologic diseases
- Drug- and/or alcohol-abuse according to local standards
- Participation in another intervention trial with interference of a primary or secondary endpoint of this study
- Inability to follow the instructions given by the investigator
- Lack of compliance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550406
Contacts
| Contact: Jin- Young Jang, M.D., PhD. | 82-2-2072-2194 | jangjy4@snu.ac.kr |
| Contact: Ye Rim Chang, M.D. | 82-2-2072-1959 | yerimchang@gmail.com |
Locations
| Korea, Republic of | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam, Bundang-gu, Korea, Republic of, 463-707 | |
| Contact: Ho‐Seong Han, M.D., PhD. 82-31-787-7091 hanhs@snubh.org | |
| Principal Investigator: Ho‐Seong Han, M.D., PhD. | |
| Sub-Investigator: Yoo-Seok Yoon, M.D., PhD. | |
| Sub-Investigator: Jai Young Cho, M.D., PhD. | |
| Department of Surgery, Seoul National University College of Medicine | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Jin- Young Jang, M.D., PhD. 82-2-2072-2194 jangjy4@gmail.com | |
| Contact: Ye Rim Chang, M.D. 82-2-2072-1959 yerimchang@gmail.com | |
| Principal Investigator: Jin- Young Jang, M.D., PhD. | |
| Sub-Investigator: Sun- Whe Kim, M.D., PhD. | |
| Sub-Investigator: Mee- Joo Kang, M.D. | |
| Sub-Investigator: In- Woong Han, M.D. | |
| Sub-Investigator: Wooil Kwon, M.D. | |
| Sub-Investigator: Jae- Woo Park, M.D. | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Woo Jung Lee, M.D., PhD. | |
| Principal Investigator: Woo Jung Lee, M.D., PhD. | |
| Sub-Investigator: Chang-Moo Kang, M.D., PhD. | |
| Sub-Investigator: Ho Kyoung Hwang, M.D. | |
| Gangnam Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 135-720 | |
| Contact: Dong-Sup Yoon, M.D., PhD. yds6110@yumc.yonsei.ac.kr | |
| Principal Investigator: Dong-Sup Yoon, M.D., PhD. | |
| Sub-Investigator: Joon Seong Park, M.D., PhD. | |
| Samsung Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 130-710 | |
| Contact: Dong Wook Choi, M.D., PhD. | |
| Principal Investigator: Dong Wook Choi, M.D., PhD. | |
| Sub-Investigator: Seong-Ho Choi, M.D., PhD. | |
| Sub-Investigator: Jin Seok Heo, M.D., PhD. | |
Sponsors and Collaborators
Seoul National University Hospital
Investigators
| Study Chair: | Jin- Young Jang, M.D. | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01550406 History of Changes |
| Other Study ID Numbers: | PFDP-2011 |
| Study First Received: | November 21, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Korea: Ministry for Health, Welfare and Family Affairs |
Keywords provided by Seoul National University Hospital:
|
Pancreatic fistula distal Pancreatectomy |
Additional relevant MeSH terms:
|
Fistula Pancreatic Fistula Digestive System Fistula Pathological Conditions, Anatomical Digestive System Diseases Pancreatic Diseases |
Glycolic acid Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013