Pancreas Tumor, Pancreatitis
Conditions
Keywords
Distal pancreatectomy, Pancreas resection
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURENo Drains
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
PROCEDUREDrains
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject has a surgical indication for distal pancreatectomy. * In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy. * At least 18 years of age. * The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group. * The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Exclusion criteria
* The subject does not have a surgical indication for distal pancreatectomy. * In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy. * Less than 18 years of age. * The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group. * The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 60-day ≥ Grade II Complication Rate | 60 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Event (SAE) Rate | 60 days | 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. |
| Median Complication Severity Grade | 60 days | 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-day Frequency of Complications | 60 days | This is the median number of complications per patients. |
| 90-day Mortality Rate | 90 days | — |
| 60-day ≥ Grade III Complication Rate | 60 days | 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. |
| Length of Stay for the Index Admission | 60 days | 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. |
| Crude Cost | 60 days | 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. |
| Composite Quality of Life Scores | 30 days and 60 days | 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. |
| Rate of Specific Complications | 60 days | 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). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 170 |
| 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). | 174 |
| Total | 344 |
Baseline characteristics
| Characteristic | Drains | Total | No Drains |
|---|---|---|---|
| Age, Continuous | 61 years | 61 years | 60 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 42 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 44 Participants | 23 Participants |
| Race (NIH/OMB) White | 123 Participants | 249 Participants | 126 Participants |
| Sex: Female, Male Female | 102 Participants | 205 Participants | 103 Participants |
| Sex: Female, Male Male | 72 Participants | 139 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 99 / 170 | 130 / 174 |
| serious Total, serious adverse events | 2 / 170 | 0 / 174 |
Outcome results
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.
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Drains | 60-day ≥ Grade II Complication Rate | 72 Participants |
| Drains | 60-day ≥ Grade II Complication Rate | 76 Participants |
Comparison: the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.p-value: 0.804Chi-squared
Secondary
60-day Frequency of Complications
This is the median number of complications per patients.
Time frame: 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Drains | 60-day Frequency of Complications | 1 Complications per patient |
| Drains | 60-day Frequency of Complications | 1 Complications per patient |
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.
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Drains | 60-day ≥ Grade III Complication Rate | 44 Participants |
| Drains | 60-day ≥ Grade III Complication Rate | 51 Participants |
Secondary
90-day Mortality Rate
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Drains | 90-day Mortality Rate | 2 Participants |
| Drains | 90-day Mortality Rate | 0 Participants |
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.
Time frame: 30 days and 60 days
Population: The result is the quality of score at 30 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Drains | Composite Quality of Life Scores | Emotional well-being subscale | 20 score on a scale |
| No Drains | Composite Quality of Life Scores | Total FACT-G score | 79 score on a scale |
| No Drains | Composite Quality of Life Scores | Social/Family well-being subscale | 21 score on a scale |
| No Drains | Composite Quality of Life Scores | FACT-Pa subscale | 25 score on a scale |
| No Drains | Composite Quality of Life Scores | Functional well-being subscale | 17 score on a scale |
| No Drains | Composite Quality of Life Scores | Total FACT-Pa score | 104 score on a scale |
| No Drains | Composite Quality of Life Scores | Physical well-being subscale | 21 score on a scale |
| Drains | Composite Quality of Life Scores | Total FACT-Pa score | 105 score on a scale |
| Drains | Composite Quality of Life Scores | Physical well-being subscale | 21 score on a scale |
| Drains | Composite Quality of Life Scores | Social/Family well-being subscale | 21 score on a scale |
| Drains | Composite Quality of Life Scores | Emotional well-being subscale | 20 score on a scale |
| Drains | Composite Quality of Life Scores | Functional well-being subscale | 17 score on a scale |
| Drains | Composite Quality of Life Scores | Total FACT-G score | 79 score on a scale |
| Drains | Composite Quality of Life Scores | FACT-Pa subscale | 26 score on a scale |
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.
Time frame: 60 days
Population: Data were not collected for analysis
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.
Time frame: 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Drains | Length of Stay for the Index Admission | 5 days |
| Drains | Length of Stay for the Index Admission | 5 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
Time frame: 60 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Drains | Median Complication Severity Grade | All patients | 1 severity grade |
| No Drains | Median Complication Severity Grade | For just the patients with complications | 4 severity grade |
| Drains | Median Complication Severity Grade | All patients | 1 severity grade |
| Drains | Median Complication Severity Grade | For just the patients with complications | 3 severity grade |
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).
Time frame: 60 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Drains | Rate of Specific Complications | Postoperative_Abdominal_FluidCollection | 38 Participants |
| No Drains | Rate of Specific Complications | SmallBowelObstruction | 1 Participants |
| No Drains | Rate of Specific Complications | Enteric_leak | 2 Participants |
| No Drains | Rate of Specific Complications | Seroma | 3 Participants |
| No Drains | Rate of Specific Complications | Pancreatic_leak_fistula | 20 Participants |
| No Drains | Rate of Specific Complications | Intra_abd_abscess | 13 Participants |
| No Drains | Rate of Specific Complications | Lymph_Leak | 1 Participants |
| No Drains | Rate of Specific Complications | Wound_Dehiscence | 6 Participants |
| No Drains | Rate of Specific Complications | Biliary_leak | 1 Participants |
| No Drains | Rate of Specific Complications | Wound_Infection | 5 Participants |
| No Drains | Rate of Specific Complications | Gastroparesis_DelayedGastricEmptying | 9 Participants |
| No Drains | Rate of Specific Complications | Fever | 36 Participants |
| No Drains | Rate of Specific Complications | Diarrhea | 17 Participants |
| Drains | Rate of Specific Complications | Fever | 30 Participants |
| Drains | Rate of Specific Complications | Diarrhea | 9 Participants |
| Drains | Rate of Specific Complications | Pancreatic_leak_fistula | 88 Participants |
| Drains | Rate of Specific Complications | Postoperative_Abdominal_FluidCollection | 15 Participants |
| Drains | Rate of Specific Complications | Biliary_leak | 1 Participants |
| Drains | Rate of Specific Complications | Enteric_leak | 1 Participants |
| Drains | Rate of Specific Complications | Lymph_Leak | 1 Participants |
| Drains | Rate of Specific Complications | Gastroparesis_DelayedGastricEmptying | 10 Participants |
| Drains | Rate of Specific Complications | SmallBowelObstruction | 3 Participants |
| Drains | Rate of Specific Complications | Seroma | 3 Participants |
| Drains | Rate of Specific Complications | Intra_abd_abscess | 15 Participants |
| Drains | Rate of Specific Complications | Wound_Dehiscence | 4 Participants |
| Drains | Rate of Specific Complications | Wound_Infection | 8 Participants |
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.
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Drains | Serious Adverse Event (SAE) Rate | 2 Participants |
| Drains | Serious Adverse Event (SAE) Rate | 0 Participants |