Distal Pancreatectomy
Conditions
Brief summary
The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.
Detailed description
The objective of this trial is to compare the effectiveness of TissueLink closure of pancreatic stump after distal pancreatectomy to that of SEAMGUARD reinforced stapler closure. Distal pancreatectomy is performed for a broad variety of indications including benign and malignant conditions. Specifically, distal pancreatectomy refers to resection of the portion of pancreas to the left of the superior mesenteric vein/portal vein trunk, excluding the duodenum and distal bile duct. Pancreatic duct leak at the resection margin is one of the most common complications of distal pancreatectomy. This complication prolongs in-patient and outpatient care and resulting in significant detriments to the patient's operative experience and increases in the financial burden of pancreatic surgery.
Interventions
DEVICESEAMGUARD with bioabsorbable staple
In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
PROCEDURETissueLink with radiofrequency ablation
After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age equal or above 18 years 2. Accepted for elective distal pancreatectomy for any indication Exclusion from randomization process: * Thickness of pancreas on preoperative CT scan images \> 2.5 cm at the site of expected transection in anterior-posterior diameter. This will be reviewed by the surgeon the day before the surgeon sees the patient to predetermine the appropriateness of the patient for the study. General study
Exclusion criteria
1. Current immunosuppressive therapy 2. Chemotherapy within 2 weeks before operation 3. Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation 4. Radiotherapy before operation 5. Inability to follow the instructions given by the investigator 6. Lack of compliance 7. Persons unable or unwilling to give informed consent to participate in this study 8. Pregnant women 9. Prisoners 10. Institutionalized individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation | 90 days from the operation | Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of the Pancreatic Fistula Leaks | 90 days post operative | Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from January 2010 to March 2014 at Mayo Clinic in Rochester, Minnesota, and at Massachusetts General Hospital in Boston, Massachusetts.
Participants by arm
| Arm | Count |
|---|---|
| SEAMGUARD With Bioabsorbable Staple SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device. | 32 |
| TissueLink With Radiofrequency Ablation TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm. | 35 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | SEAMGUARD With Bioabsorbable Staple | TissueLink With Radiofrequency Ablation | Total |
|---|---|---|---|
| Age, Continuous | 59.84 years STANDARD_DEVIATION 12.73 | 56.29 years STANDARD_DEVIATION 12.79 | 57.99 years STANDARD_DEVIATION 12.79 |
| Body Mass Index (BMI) | 27.60 kg/m^2 STANDARD_DEVIATION 5.08 | 28.56 kg/m^2 STANDARD_DEVIATION 5.25 | 28.09 kg/m^2 STANDARD_DEVIATION 5.15 |
| Region of Enrollment United States | 32 participants | 35 participants | 67 participants |
| Sex: Female, Male Female | 16 Participants | 23 Participants | 39 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 32 | 23 / 35 |
| serious Total, serious adverse events | 4 / 32 | 5 / 35 |
Outcome results
Primary
Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation
Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.
Time frame: 90 days from the operation
Population: Intention-to-treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SEAMGUARD With Bioabsorbable Staple | Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation | 12.5 percentage of subjects |
| TissueLink With Radiofrequency Ablation | Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation | 22.9 percentage of subjects |
p-value: 0.35Chi-squared
Secondary
Severity of the Pancreatic Fistula Leaks
Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.
Time frame: 90 days post operative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SEAMGUARD With Bioabsorbable Staple | Severity of the Pancreatic Fistula Leaks | Clinically significant pancreatic fistula leaks | 4 Pancreatic fistula leaks |
| SEAMGUARD With Bioabsorbable Staple | Severity of the Pancreatic Fistula Leaks | Non-clinically significant pancreatic fistula leak | 11 Pancreatic fistula leaks |
| TissueLink With Radiofrequency Ablation | Severity of the Pancreatic Fistula Leaks | Clinically significant pancreatic fistula leaks | 8 Pancreatic fistula leaks |
| TissueLink With Radiofrequency Ablation | Severity of the Pancreatic Fistula Leaks | Non-clinically significant pancreatic fistula leak | 14 Pancreatic fistula leaks |