Clinical trial NCT02270554: A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy
Official title: A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

Detailed description: Reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. There is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.This study will be conducted to scientifically investigate the impact of Endo GIA Reinforced Reload with Tri-Staple Technology in distal pancreatectomy. The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

Eligibility criteria: Inclusion Criteria:

1. disease of pancreatic body and tail
2. PS (ECOG Performance Status Scale)0-1
3. Age: 20 years or older
4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis
5. Patients who can provide written informed consent

Exclusion Criteria:

1. Patients with severe ischemic cardiac disease
2. Patients with severe liver cirrhosis or active hepatitis
3. Patients with respiratory illness that requires oxygen administration
4. Patients with chronic renal failure requiring dialysis
5. Patients requiring other organ resection
6. Patients who are unfit for the study as determined by the attending physician

Primary outcomes:
measure: Incidence of pancreatic fistula grade B/C
timeFrame: Ninety days after operation
Secondary outcomes:
measure: Incidence of pancreatic fistula defined by ISGPF classification
timeFrame: Ninety days after operation
measure: Incidence of pancreatic fistula grade C defined by ISGPF classification
timeFrame: Ninety days after operation
measure: Incidence of intraabdominal bleeding
timeFrame: Ninety days after operation
measure: Morbidity
timeFrame: Ninety days after operation
measure: Mortality
timeFrame: Ninety days after operation
measure: Postoperative hospital stay
timeFrame: Ninety days after operation
measure: Hemostasis condition of staple line
timeFrame: during operation
measure: Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line
timeFrame: during operation
measure: Period of drain insertion
timeFrame: Ninety days after operation
measure: Damage of pancreatic stump
timeFrame: during operation
measure: Frequency of additional suture of pancreatic stump
timeFrame: during operation
measure: Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
timeFrame: Ninety days after operation
Other outcomes:
Locations:
city: Amagasaki, Hyogo
country: Japan
facility: Kansai Rosai Hospital
city: Hirakata, Osaka
country: Japan
facility: Kansai Medical University
city: Hiroshima, Hiroshima
country: Japan
facility: Hiroshima University
city: Kashihara, Nara
country: Japan
facility: Nara Medical University
city: Kobe, Hyogo
country: Japan
facility: Kobe University
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Nagoya, Aichi
country: Japan
facility: Nagoya University
city: Nishinomiya, Hyogo
country: Japan
facility: Hyogo College of Medicine
city: Osaka
country: Japan
facility: Osaka University
city: Sayama, Osaka
country: Japan
facility: Kinki University
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
affiliation: Wakayama Medical University
name: Hiroki Yamaue, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawai M, Hirono S, Okada KI, Satoi S, Yanagimoto H, Kon M, Murakami Y, Kondo N, Sho M, Akahori T, Toyama H, Fukumoto T, Fujii T, Matsumoto I, Eguchi H, Ikoma H, Takeda Y, Fujimoto J, Yamaue H. Reinforced staplers for distal pancreatectomy. Langenbecks Arch Surg. 2017 Dec;402(8):1197-1204. doi: 10.1007/s00423-017-1634-1. Epub 2017 Nov 4.