Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01359410

Enrollment

112

Registered

2011-05-24

Start date

2007-06-30

Completion date

2011-09-30

Last updated

2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

Pancreas adenocarcinoma, Precancerous lesions of the pancreas (mucinous cystic neoplasms, IPMN), Pancreas neuroendocrine cancer

Brief summary

The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).

Detailed description

Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.

Interventions

DEVICEMesh reinforced staple line (SEAMGUARD)

Reinforce the pancreatic transaction with SEAMGUARD®

DEVICEStapled without mesh reinforcement (PER-STRIPS DRY)

Stapled without mesh reinforcement (PERI-STRIPS DRY®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Participant's were blinded to the results of the randomization for 6 weeks.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization. * No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.

Exclusion criteria

None specified

Design outcomes

Primary

Measure	Time frame	Description
Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System	100 days or removal of drain	* 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

Secondary

Measure	Time frame
Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System	100 days or removal of drain
Time to Drain Removal	100 days or removal of drain
Number of Non-pancreatic Adverse Events	100 days or removal of drain

Countries

United States

Participant flow

Recruitment details

The study opened to participant enrollment on 06/28/2007 and closed to participant enrollment on 10/28/2011.

Pre-assignment details

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.

Participants by arm

Arm	Count
Stapled Transection With Mesh Reinforcement Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)	54
Stapled Transection Without Mesh Reinforcement	46
Total	100

Baseline characteristics

Characteristic	Stapled Transection With Mesh Reinforcement	Stapled Transection Without Mesh Reinforcement	Total
Age, Continuous	57.5 years STANDARD_DEVIATION 15.6	58.6 years STANDARD_DEVIATION 13.4	58.0 years STANDARD_DEVIATION 14.7
Indication for operation Adenocarcinoma	8 Participants	10 Participants	18 Participants
Indication for operation Benign pancreatic tumor	24 Participants	13 Participants	37 Participants
Indication for operation Chronic pancreatitis	3 Participants	4 Participants	7 Participants
Indication for operation Metastatic tumor to pancreas	3 Participants	3 Participants	6 Participants
Indication for operation Neuroendocrine tumor	12 Participants	14 Participants	26 Participants
Indication for operation Normal pancreas	4 Participants	2 Participants	6 Participants
Region of Enrollment United States	54 participants	46 participants	100 participants
Sex: Female, Male Female	34 Participants	21 Participants	55 Participants
Sex: Female, Male Male	20 Participants	25 Participants	45 Participants
Smoking history Nonsmoker	34 Participants	26 Participants	60 Participants
Smoking history Smoker	20 Participants	20 Participants	40 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 54	5 / 46
serious Total, serious adverse events	1 / 54	11 / 46

Outcome results

Primary

Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System

* 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