Trial Outcomes & Findings for TissueLink Versus SEAMGUARD After Distal Pancreatectomy (NCT NCT01051856)

NCT ID: NCT01051856

Last Updated: 2023-06-22

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 68 participants
• Primary outcome timeframe: 90 days from the operation
• Results posted on: 2023-06-22

Participant Flow

Subjects were enrolled from January 2010 to March 2014 at Mayo Clinic in Rochester, Minnesota, and at Massachusetts General Hospital in Boston, Massachusetts.

Participant milestones

Measure	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.	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.
Overall Study STARTED	33	35
Overall Study COMPLETED	32	35
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

TissueLink Versus SEAMGUARD After Distal Pancreatectomy

Baseline characteristics by cohort

Measure	SEAMGUARD With Bioabsorbable Staple n=32 Participants 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.	TissueLink With Radiofrequency Ablation n=35 Participants 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.	Total n=67 Participants Total of all reporting groups
Age, Continuous	59.84 years STANDARD_DEVIATION 12.73 • n=5 Participants	56.29 years STANDARD_DEVIATION 12.79 • n=7 Participants	57.99 years STANDARD_DEVIATION 12.79 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	35 participants n=7 Participants	67 participants n=5 Participants
Body Mass Index (BMI)	27.60 kg/m^2 STANDARD_DEVIATION 5.08 • n=5 Participants	28.56 kg/m^2 STANDARD_DEVIATION 5.25 • n=7 Participants	28.09 kg/m^2 STANDARD_DEVIATION 5.15 • n=5 Participants

PRIMARY outcome

Timeframe: 90 days from the operation

Population: Intention-to-treat analysis

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.

Outcome measures

Measure	SEAMGUARD With Bioabsorbable Staple n=32 Participants 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.	TissueLink With Radiofrequency Ablation n=35 Participants 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.
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	22.9 percentage of subjects

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SEAMGUARD With Bioabsorbable Staple n=32 Participants 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.	TissueLink With Radiofrequency Ablation n=35 Participants 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.
Severity of the Pancreatic Fistula Leaks Clinically significant pancreatic fistula leaks	4 Pancreatic fistula leaks	8 Pancreatic fistula leaks
Severity of the Pancreatic Fistula Leaks Non-clinically significant pancreatic fistula leak	11 Pancreatic fistula leaks	14 Pancreatic fistula leaks

Adverse Events

SEAMGUARD With Bioabsorbable Staple

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

TissueLink With Radiofrequency Ablation

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	SEAMGUARD With Bioabsorbable Staple n=32 participants at risk 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.	TissueLink With Radiofrequency Ablation n=35 participants at risk 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.
Gastrointestinal disorders Hospital readmission for pancreatic fistula	12.5% 4/32 • Number of events 4 • Adverse events were collected within the 90 day perioperative period.	14.3% 5/35 • Number of events 5 • Adverse events were collected within the 90 day perioperative period.
Surgical and medical procedures Percutaneous Drainage	12.5% 4/32 • Number of events 4 • Adverse events were collected within the 90 day perioperative period.	14.3% 5/35 • Number of events 5 • Adverse events were collected within the 90 day perioperative period.
Blood and lymphatic system disorders Pseudoaneurysm due to pancreatic fistula	0.00% 0/32 • Adverse events were collected within the 90 day perioperative period.	2.9% 1/35 • Number of events 1 • Adverse events were collected within the 90 day perioperative period.
General disorders Intensive Care Unit or Progressive Care Unit Stay	9.4% 3/32 • Number of events 3 • Adverse events were collected within the 90 day perioperative period.	2.9% 1/35 • Number of events 1 • Adverse events were collected within the 90 day perioperative period.

Other adverse events

Measure	SEAMGUARD With Bioabsorbable Staple n=32 participants at risk 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.	TissueLink With Radiofrequency Ablation n=35 participants at risk 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.
Gastrointestinal disorders Pancreatic fistula drainage longer than 3 weeks	15.6% 5/32 • Number of events 5 • Adverse events were collected within the 90 day perioperative period.	25.7% 9/35 • Number of events 9 • Adverse events were collected within the 90 day perioperative period.
Gastrointestinal disorders Drained Amylase 3 Times Normal Upper Limit	46.9% 15/32 • Number of events 15 • Adverse events were collected within the 90 day perioperative period.	65.7% 23/35 • Number of events 23 • Adverse events were collected within the 90 day perioperative period.
Gastrointestinal disorders Specific Treatment for Pancreatic Fistula	12.5% 4/32 • Number of events 4 • Adverse events were collected within the 90 day perioperative period.	22.9% 8/35 • Number of events 8 • Adverse events were collected within the 90 day perioperative period.
Gastrointestinal disorders Pancreatic Fistula Documented by X-Ray	12.5% 4/32 • Number of events 4 • Adverse events were collected within the 90 day perioperative period.	14.3% 5/35 • Number of events 5 • Adverse events were collected within the 90 day perioperative period.
Infections and infestations Postoperative Infection	21.9% 7/32 • Number of events 7 • Adverse events were collected within the 90 day perioperative period.	22.9% 8/35 • Number of events 8 • Adverse events were collected within the 90 day perioperative period.

Additional Information

Florencia G. Que, MD

Mayo Clinic

Phone: 507-284-6178

Email: que.florencia@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place