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This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.
The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula.
Hypothesis:
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.
Objectives:
Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
Secondary:
A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Drains | Experimental | Patients who will not receive intraperitoneal drainage following pancreas resection. |
|
| Drains | Experimental | Patients who will receive drains, the standard of care treatment, following pancreas resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Drains | Procedure | A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 60-day ≥ Grade II Complication Rate | The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 60-day ≥ Grade III Complication Rate | This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William E Fisher, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health | Gainesville | Florida | 32611 | United States | ||
| University of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21689234 | Background | Fisher WE, Hodges SE, Silberfein EJ, Artinyan A, Ahern CH, Jo E, Brunicardi FC. Pancreatic resection without routine intraperitoneal drainage. HPB (Oxford). 2011 Jul;13(7):503-10. doi: 10.1111/j.1477-2574.2011.00331.x. | |
| 24374513 | Background | Van Buren G 2nd, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, Vollmer C, Velanovich V, Riall T, Muscarella P, Trevino J, Nakeeb A, Schmidt CM, Behrns K, Ellison EC, Barakat O, Perry KA, Drebin J, House M, Abdel-Misih S, Silberfein EJ, Goldin S, Brown K, Mohammed S, Hodges SE, McElhany A, Issazadeh M, Jo E, Mo Q, Fisher WE. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460. |
| Label | URL |
|---|---|
| Elkins Pancreas Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Drains | Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group. |
| FG001 | Drains | Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Drains | Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group. |
| BG001 | Drains |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 60-day ≥ Grade II Complication Rate | The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3. | Posted | Count of Participants | Participants | 60 days |
|
30 days and 60 days
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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 | No Drains | Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 intra-abdominal infection and pancreatic leak/fistula | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment | Both SAEs were categorized as grade 3 or higher complications. Both patients were assigned to the "No Drain Group" and developed a grade 3 intra-abdominal infection and pancreatic leak/fistula. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic_leak_fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
A potential weakness of the current study is that it took 5 years to reach targeted accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy McElhany, Clinical Research Manager | Baylor College of Medicine | 7137981016 | pancreas@bcm.edu |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Drains | Procedure | A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care). |
|
|
| 60 days |
| Serious Adverse Event (SAE) Rate | This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics. | 60 days |
| Median Complication Severity Grade | This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced | 60 days |
| 60-day Frequency of Complications | This is the median number of complications per patients. | 60 days |
| 90-day Mortality Rate | 90 days |
| Rate of Specific Complications | The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0). | 60 days |
| Length of Stay for the Index Admission | This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported. | 60 days |
| Crude Cost | This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis. | 60 days |
| Composite Quality of Life Scores | Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis. The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0~144. A lower score represents the worst quality of life. | 30 days and 60 days |
| Tampa |
| Florida |
| 33606 |
| United States |
| Indiana University - Purdue University Indianapolis | Indianapolis | Indiana | 46202 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Winthrop-University Hospital | Mineola | New York | 11501 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29424 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Baylor College of Medicine | Houston | Texas | 77338 | United States |
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Drains |
Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care). |
|
|
|
| Secondary | 60-day ≥ Grade III Complication Rate | This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3. | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Serious Adverse Event (SAE) Rate | This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics. | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Median Complication Severity Grade | This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced | Posted | Median | Inter-Quartile Range | severity grade | 60 days |
|
|
|
| Secondary | 60-day Frequency of Complications | This is the median number of complications per patients. | Posted | Median | Inter-Quartile Range | Complications per patient | 60 days |
|
|
|
| Secondary | 90-day Mortality Rate | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Rate of Specific Complications | The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0). | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Length of Stay for the Index Admission | This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported. | Posted | Median | Inter-Quartile Range | days | 60 days |
|
|
|
| Secondary | Crude Cost | This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis. | Data were not collected for analysis | Posted | 60 days |
|
|
| Secondary | Composite Quality of Life Scores | Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis. The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0~144. A lower score represents the worst quality of life. | The result is the quality of score at 30 days. | Posted | Median | Inter-Quartile Range | score on a scale | 30 days and 60 days |
|
|
|
| 2 |
| 170 |
| 99 |
| 170 |
| EG001 | Drains | Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care). | 0 | 174 | 130 | 174 |
|
| Postoperative_Abdominal_FluidCollection | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Biliary_leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enteric_leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymph_Leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroparesis_DelayedGastricEmptying | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| SmallBowelObstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seroma | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Intra_abd_abscess | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Wound_Dehiscence | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Wound_Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fever | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Biliary_leak |
|
| Enteric_leak |
|
| Lymph_Leak |
|
| Diarrhea |
|
| Gastroparesis_DelayedGastricEmptying |
|
| SmallBowelObstruction |
|
| Seroma |
|
| Intra_abd_abscess |
|
| Wound_Dehiscence |
|
| Wound_Infection |
|
| Fever |
|
| Emotional well-being subscale |
|
| Functional well-being subscale |
|
| Total FACT-G score |
|
| FACT-Pa subscale |
|
| Total FACT-Pa score |
|