Not provided
Not provided
Not provided
Not provided
Not provided
The 3rd interim analysis found superiority in the mesh reinforcement arm
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapled transection with mesh reinforcement | Active Comparator | Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®) |
|
| Stapled transection without mesh reinforcement | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh reinforced staple line (SEAMGUARD) | Device | Reinforce the pancreatic transaction with SEAMGUARD® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System |
| 100 days or removal of drain |
| Measure | Description | 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria: None specified
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Hawkins, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19852096 | Background | Hawkins WG. To mesh or not to mesh, that is the question: comment on "Use of Seamguard to prevent pancreatic leak following distal pancreatectomy". Arch Surg. 2009 Oct;144(10):899. doi: 10.1001/archsurg.2009.34. No abstract available. | |
| 19590620 | Background | Johnston FM, Cavataio A, Strasberg SM, Hamilton NA, Simon PO Jr, Trinkaus K, Doyle MB, Mathews BD, Porembka MR, Linehan DC, Hawkins WG. The effect of mesh reinforcement of a stapled transection line on the rate of pancreatic occlusion failure after distal pancreatectomy: review of a single institution's experience. HPB (Oxford). 2009 Feb;11(1):25-31. doi: 10.1111/j.1477-2574.2008.00001.x. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The study opened to participant enrollment on 06/28/2007 and closed to participant enrollment on 10/28/2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stapled Transection With Mesh Reinforcement | Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®) |
| FG001 | Stapled Transection Without Mesh Reinforcement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stapled Transection With Mesh Reinforcement | Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®) |
| BG001 | Stapled Transection Without Mesh Reinforcement | |
| 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 | Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System |
| (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. | Posted | Count of Participants | Participants | 100 days or removal of drain |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stapled Transection With Mesh Reinforcement | Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fistula (leak) | Gastrointestinal disorders | ISGPF | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Vascular disorders | Clavien-Dindo | Systematic Assessment |
The investigators were unable to identify any complications directly due to the mesh materials. It is possible these complications are very rare and that the study did not include enough participants to potentially identify these potential harms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Hawkins, M.D. | Washington University School of Medicine | 314-362-7046 | hawkinsw@wustl.edu |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Participant's were blinded to the results of the randomization for 6 weeks.
| Stapled without mesh reinforcement (PER-STRIPS DRY) | Device | Stapled without mesh reinforcement (PERI-STRIPS DRY®) |
|
| Number of Non-pancreatic Adverse Events |
| 100 days or removal of drain |
| 17390188 | Background | Thaker RI, Matthews BD, Linehan DC, Strasberg SM, Eagon JC, Hawkins WG. Absorbable mesh reinforcement of a stapled pancreatic transection line reduces the leak rate with distal pancreatectomy. J Gastrointest Surg. 2007 Jan;11(1):59-65. doi: 10.1007/s11605-006-0042-6. |
| 22534422 | Derived | Hamilton NA, Porembka MR, Johnston FM, Gao F, Strasberg SM, Linehan DC, Hawkins WG. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial. Ann Surg. 2012 Jun;255(6):1037-42. doi: 10.1097/SLA.0b013e31825659ef. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Indication for operation | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Stapled Transection With Mesh Reinforcement | Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®) |
| OG001 | Stapled Transection Without Mesh Reinforcement |
|
|
| Secondary | Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System | (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. | Posted | Count of Participants | Participants | 100 days or removal of drain |
|
|
|
| Secondary | Time to Drain Removal | (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. | Posted | Median | 95% Confidence Interval | days | 100 days or removal of drain |
|
|
|
| Secondary | Number of Non-pancreatic Adverse Events | Posted | Number | non-pancreatic adverse events | 100 days or removal of drain |
|
|
|
| Post-Hoc | Intraoperative Complications Incurred by Participants | Posted | Number | intraoperative complications | 100 days or removal of drain |
|
|
|
| 1 |
| 54 |
| 3 |
| 54 |
| EG001 | Stapled Transection Without Mesh Reinforcement | 11 | 46 | 5 | 46 |
| Myocardial infarction | Cardiac disorders | Clavien-Dindo | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Clavien-Dindo | Systematic Assessment |
|
| Pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Postoperative bleeding requiring transfusion | General disorders | Clavien-Dindo | Systematic Assessment |
|
| Postoperative bleeding requiring reoperation | General disorders | Clavien-Dindo | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Clavien-Dindo | Systematic Assessment |
|
| Acute renal failure (not requiring dialysis) | Renal and urinary disorders | Clavien-Dindo | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Clavien-Dindo | Systematic Assessment |
|
| New onset diabetes | Metabolism and nutrition disorders | Clavien-Dindo | Systematic Assessment |
|
| Gastrointestinal bleed | Gastrointestinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Gastrointestinal anastomosis leak | Gastrointestinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Prolonged ileus | Gastrointestinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Other intraabdominal abscess | Gastrointestinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Anaphylactic reaction to medication | Immune system disorders | Clavien-Dindo | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Clavien-Dindo | Systematic Assessment |
|
| Vascular psedoaneurysm | Vascular disorders | Clavien-Dindo | Systematic Assessment |
|
| IV infiltration with skin necrosis | Injury, poisoning and procedural complications | Clavien-Dindo | Systematic Assessment |
|
| Wound infection | Injury, poisoning and procedural complications | Clavien-Dindo | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Hepatic artery injury |
|
| Umbilical tape in staple line requiring revision |
|
| Pulmonary embolus |
|
| Splenic avulsion |
|
| Deserosalization of stomach |
|