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The trial closed early due to poor accrual.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEAMGUARD with bioabsorbable staple | Active Comparator | In this arm pancreatic transection will be executed using an endoscopic linear stapling device. The individual staple depth can be chosen by the operating surgeon. Bioabsorbable Mesh sleeves specifically manufactured for the chosen staple depth and cartridge length will be placed over the stapler before firing. |
|
| TissueLink with radiofrequency ablation | Active Comparator | After pancreatic transection, with any method chosen by the operating surgeon, the pancreatic remnant will be treated with TissueLink alone for an ablation depth (thickness) of approximately 7 mm using electrosurgical generator settings of 100 W and a saline drip rate of 1-2 drops per second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEAMGUARD with bioabsorbable staple | Device | In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days from the operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days post operative |
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Inclusion criteria:
Exclusion from randomization process:
General study exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florencia G Que, M.D. S | Mayo Clinic, Rochester, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusettes General Hospital | Boston | Massachusetts | 02144 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16003309 | Background | Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001. | |
| 27916372 |
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Subjects were enrolled from January 2010 to March 2014 at Mayo Clinic in Rochester, Minnesota, and at Massachusetts General Hospital in Boston, Massachusetts.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | TissueLink With Radiofrequency Ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to-treat analysis | Posted | Number | percentage of subjects | 90 days from the operation |
|
Adverse events were collected within the 90 day perioperative period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital readmission for pancreatic fistula | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic fistula drainage longer than 3 weeks | Gastrointestinal disorders | Systematic Assessment |
The trial closed early due to poor accrual of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Florencia G. Que, MD | Mayo Clinic | 507-284-6178 | que.florencia@mayo.edu |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| TissueLink with radiofrequency ablation | Procedure | 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. |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Shubert CR, Ferrone CR, Fernandez-Del Castillo C, Kendrick ML, Farnell MB, Smoot RL, Truty MJ, Que FG. A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856. J Surg Res. 2016 Nov;206(1):32-40. doi: 10.1016/j.jss.2016.06.034. Epub 2016 Jun 17. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | 34 participants in the TissueLink arm were included in the BMI analysis; the data were not available on one participant. | Mean | Standard Deviation | kg/m^2 |
|
| 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. |
|
|
|
| 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. | Posted | Number | Pancreatic fistula leaks | 90 days post operative |
|
|
|
| 4 |
| 32 |
| 15 |
| 32 |
| EG001 | 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. | 5 | 35 | 23 | 35 |
| Percutaneous Drainage | Surgical and medical procedures | Systematic Assessment |
|
| Pseudoaneurysm due to pancreatic fistula | Blood and lymphatic system disorders | Systematic Assessment |
|
| Intensive Care Unit or Progressive Care Unit Stay | General disorders | Systematic Assessment |
|
| Drained Amylase 3 Times Normal Upper Limit | Gastrointestinal disorders | Systematic Assessment |
|
| Specific Treatment for Pancreatic Fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatic Fistula Documented by X-Ray | Gastrointestinal disorders | Systematic Assessment |
|
| Postoperative Infection | Infections and infestations | Systematic Assessment |
|
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