Trial Outcomes & Findings for Reinforced Staple Line on Leak Rate in Distal Pancreatectomy (NCT NCT01359410)
NCT ID: NCT01359410
Last Updated: 2017-05-10
Results Overview
* Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way * Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure * Grade B: \>3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (\>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula * Grade C: \>3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (\>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula
TERMINATED
NA
112 participants
100 days or removal of drain
2017-05-10
Participant Flow
The study opened to participant enrollment on 06/28/2007 and closed to participant enrollment on 10/28/2011.
112 participants were enrolled to the study but 12 participants (1 participant declined to be in the study and 11 participants were found to be ineligible) were excluded from the study before randomization to the arms.
Participant milestones
| Measure |
Stapled Transection With Mesh Reinforcement
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
46
|
|
Overall Study
COMPLETED
|
54
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
Baseline characteristics by cohort
| Measure |
Stapled Transection With Mesh Reinforcement
n=54 Participants
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=46 Participants
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
46 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Indication for operation
Adenocarcinoma
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Indication for operation
Neuroendocrine tumor
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Indication for operation
Metastatic tumor to pancreas
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Indication for operation
Benign pancreatic tumor
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Indication for operation
Chronic pancreatitis
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Indication for operation
Normal pancreas
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Smoking history
Nonsmoker
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Smoking history
Smoker
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days or removal of drainPopulation: (1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.
* Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way * Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure * Grade B: \>3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (\>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula * Grade C: \>3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (\>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula
Outcome measures
| Measure |
Stapled Transection With Mesh Reinforcement
n=53 Participants
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=45 Participants
|
|---|---|---|
|
Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 100 days or removal of drainPopulation: (1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.
Outcome measures
| Measure |
Stapled Transection With Mesh Reinforcement
n=53 Participants
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=45 Participants
|
|---|---|---|
|
Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System
|
21 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 100 days or removal of drainPopulation: (1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.
Outcome measures
| Measure |
Stapled Transection With Mesh Reinforcement
n=53 Participants
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=45 Participants
|
|---|---|---|
|
Time to Drain Removal
|
9 days
Interval 6.0 to 19.0
|
17 days
Interval 7.0 to 40.0
|
SECONDARY outcome
Timeframe: 100 days or removal of drainOutcome measures
| Measure |
Stapled Transection With Mesh Reinforcement
n=54 Participants
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=46 Participants
|
|---|---|---|
|
Number of Non-pancreatic Adverse Events
|
21 non-pancreatic adverse events
|
28 non-pancreatic adverse events
|
POST_HOC outcome
Timeframe: 100 days or removal of drainOutcome measures
| Measure |
Stapled Transection With Mesh Reinforcement
n=54 Participants
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=46 Participants
|
|---|---|---|
|
Intraoperative Complications Incurred by Participants
Staple misfire splenic artery requiring revision
|
0 intraoperative complications
|
1 intraoperative complications
|
|
Intraoperative Complications Incurred by Participants
Bleeding at staple line
|
0 intraoperative complications
|
1 intraoperative complications
|
|
Intraoperative Complications Incurred by Participants
Hepatic artery injury
|
1 intraoperative complications
|
0 intraoperative complications
|
|
Intraoperative Complications Incurred by Participants
Umbilical tape in staple line requiring revision
|
2 intraoperative complications
|
0 intraoperative complications
|
|
Intraoperative Complications Incurred by Participants
Pulmonary embolus
|
1 intraoperative complications
|
0 intraoperative complications
|
|
Intraoperative Complications Incurred by Participants
Splenic avulsion
|
1 intraoperative complications
|
0 intraoperative complications
|
|
Intraoperative Complications Incurred by Participants
Deserosalization of stomach
|
1 intraoperative complications
|
0 intraoperative complications
|
Adverse Events
Stapled Transection With Mesh Reinforcement
Stapled Transection Without Mesh Reinforcement
Serious adverse events
| Measure |
Stapled Transection With Mesh Reinforcement
n=54 participants at risk
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=46 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Fistula (leak)
|
1.9%
1/54
|
23.9%
11/46
|
Other adverse events
| Measure |
Stapled Transection With Mesh Reinforcement
n=54 participants at risk
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Stapled Transection Without Mesh Reinforcement
n=46 participants at risk
|
|---|---|---|
|
Vascular disorders
Cerebrovascular accident
|
1.9%
1/54
|
0.00%
0/46
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/54
|
2.2%
1/46
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
2/54
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
|
3.7%
2/54
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.6%
3/54
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/54
|
2.2%
1/46
|
|
General disorders
Postoperative bleeding requiring transfusion
|
0.00%
0/54
|
2.2%
1/46
|
|
General disorders
Postoperative bleeding requiring reoperation
|
1.9%
1/54
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/54
|
2.2%
1/46
|
|
Renal and urinary disorders
Acute renal failure (not requiring dialysis)
|
0.00%
0/54
|
2.2%
1/46
|
|
Infections and infestations
Urinary tract infection
|
3.7%
2/54
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
New onset diabetes
|
0.00%
0/54
|
2.2%
1/46
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/54
|
2.2%
1/46
|
|
Gastrointestinal disorders
Gastrointestinal anastomosis leak
|
1.9%
1/54
|
2.2%
1/46
|
|
Gastrointestinal disorders
Prolonged ileus
|
3.7%
2/54
|
4.3%
2/46
|
|
Gastrointestinal disorders
Other intraabdominal abscess
|
1.9%
1/54
|
4.3%
2/46
|
|
Immune system disorders
Anaphylactic reaction to medication
|
0.00%
0/54
|
2.2%
1/46
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/54
|
2.2%
1/46
|
|
Vascular disorders
Vascular psedoaneurysm
|
0.00%
0/54
|
4.3%
2/46
|
|
Injury, poisoning and procedural complications
IV infiltration with skin necrosis
|
1.9%
1/54
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Wound infection
|
3.7%
2/54
|
10.9%
5/46
|
Additional Information
William Hawkins, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place