UMIN-CTR Clinical Trial

Public title

Efficacy of polyglycolic acid felt in prevention of pancreatic fistula after distal pancreatectomy

Acronym

Efficacy of polyglycolic acid felt in prevention of pancreatic fistula after distal pancreatectomy

Scientific Title

Efficacy of polyglycolic acid felt in prevention of pancreatic fistula after distal pancreatectomy

Scientific Title:Acronym

Efficacy of polyglycolic acid felt in prevention of pancreatic fistula after distal pancreatectomy

Region

Japan

Condition

patients undergoing distal pancreatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of polyglycolic acid felt to prevent pancreatic fistula after distal pancreatectomy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The frequency of occurrence of pancreatic fistula

Key secondary outcomes

morbidity, mortality, postoperative hospital stay and the incidence of late pancreatic pseudocyst

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

1)The pancreas transection are performed using the Endoscopic linear Cutter Echelon 60TM (EC60A), green cartridge (ECR60G).The closure jaw of the staple are clamped carefully and slowly at a fixed speed, taking more than approximately 5 min and fired as slowly as possible.
2)We will be stuck with PGA felt the (Neoveil) moistened with saline to pancreatic stump .

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) The distal pancreatectomy cases against pancreatic tail region diseases, including inflammatory diseases, such as tumor-forming pancreatitis.
2) the presence or absence of the presence or absence spleen preservation of vascular resection does not matter.
3) Cases we planed to use a patch of PGA felt as pancreatic stump treatment.
4) Preoperative ECOG of Performance Status (PS) is 0-1.
5) Older than 20 years old
6) Cases that do not recognize the obvious distant metastases at inspection.
7) Major organ function is preserved.
Patients meet all of the following in the 14 days prior and subsequent inspection of the registration date.
1. white blood cell (WBC): 2,000 / mm3 < WBC <12,000 / mm3
2. neutrophil count (Neut): Neut > 1,000 / mm3
3. hemoglobin (Hb): Hb > 9.0 g / dL
4. platelet count (Plt): Plt > 80,000 / mm3
5. serum total bilirubin (TB): TB < 2.0 mg / dL
6. serum AST: AST < 150 IU / L
7. serum ALT: ALT < 150 IU / L
8. serum creatinine (Cr): Cr < 1.5mg / dL
9. serum albumin (Alb): Alb > 2.5 g / dL
8) consent from patients have been obtained in writing.

Key exclusion criteria

1) Patients with a history of hypersensitivity to components of PGA felt.
2) Cases with serious complications such as heart disease and kidney disease.
3) Drug abusers, mentally unstable patients, and patients judged difficult to communicate with physicians.
4) Pregnant women or women who may possibly be pregnant.
5) Patients undergoing treatment with aprotinin, procoagulant and anti-thrombolytic agents are excluded because there is a possibility that appears thrombophilia may occur by using a tissue adhesive.
6) Patient judged inadguate.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hidetoshi Eguchi

Organization

Osaka University, Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

Address

2-2, Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3251

Email

heguchi@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hidetoshi Eguchi

Organization

Osaka University, Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

Address

2-2, Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3251

Homepage URL

Email

thata20@gesurg.med.osaka-u.ac.jp

Institute

Multicenter Clinical Study Group of Osaka

Institute

Department

Personal name

Organization

Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015

Year

02

Month

23

Day

Date of IRB

Anticipated trial start date

2015

Year

02

Month

23

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

04

Month

17

Day

Last modified on

2015

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019614