Pancreas TumorNCT01441492
Pancreas Resection With and Without Drains
A study testing No Drains and Drains in people with Pancreas Tumor and Pancreatitis, run by Baylor College of Medicine at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Tumor, Pancreatitis
- What is being tested?
- No Drains and Drains
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Sep 2011to 25 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Medical University of South Carolina
Charleston, South Carolina, 29424
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
University of Florida Health
Gainesville, Florida, 32611
University of Texas Medical Branch
Galveston, Texas, 77555
Baylor College of Medicine
Houston, Texas, 77338
Indiana University - Purdue University Indianapolis
Indianapolis, Indiana, 46202
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Winthrop-University Hospital
Mineola, New York, 11501
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of South Florida
Tampa, Florida, 33606
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 1N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
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.
Read the 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:
- 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.
- Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- 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.
- 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.
- Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- 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.
- Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- Conditions
- Pancreas Tumor, Pancreatitis
- Being tested
- No Drains, Drains
- Keywords
- Distal pancreatectomy, Pancreas resection
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No DrainsProcedure or surgery
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
DrainsProcedure or surgery
Also called The specific brand of drain is not contolled.
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
| Study group | Role | What they receive |
|---|---|---|
| No Drains | Experimental | Patients who will not receive intraperitoneal drainage following pancreas resection. Receives: Procedure: No Drains |
| Drains | Experimental | Patients who will receive drains, the standard of care treatment, following pancreas resection. Receives: Procedure: Drains |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 60 days
60-day Frequency of Complications
This is the median number of complications per patients.
Measured: 60 days
90-day Mortality Rate
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2016
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreas TumorStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William E Fisher, Baylor College of Medicine
- Investigators
- William E Fisher, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441492
- Sponsor's protocol ID
- H-28324
- Status last verified
- Aug 2020
- First submitted
- 23 Sep 2011
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21689234Van 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.
PubMed 24374513
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
- ClinicalTrials.gov ID
- NCT01441492
- Acronym / sponsor ID
- H-28324
- Conditions
- Pancreas Tumor, Pancreatitis
- Keywords
- Distal pancreatectomy, Pancreas resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- 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.
- 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.
- Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- 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.
- Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
- Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Drains | Experimental | Procedure: No DrainsPatients who will not receive intraperitoneal drainage following pancreas resection. |
| Drains | Experimental | Procedure: DrainsPatients who will receive drains, the standard of care treatment, following pancreas resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No DrainsA closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group. | Procedure or surgery | No Drains |
| DrainsAlso: The specific brand of drain is not contolled.A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care). | Procedure or surgery | Drains |
Primary outcome
60-day ≥ Grade II Complication Rate
Time frame: 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.
9 secondary outcomes
60-day ≥ Grade III Complication Rate
Time frame: 60 days
Serious Adverse Event (SAE) Rate
Time frame: 60 days
Median Complication Severity Grade
Time frame: 60 days
60-day Frequency of Complications
Time frame: 60 days
90-day Mortality Rate
Time frame: 90 days
Rate of Specific Complications
Time frame: 60 days
Length of Stay for the Index Admission
Time frame: 60 days
Crude Cost
Time frame: 60 days
Composite Quality of Life Scores
Time frame: 30 days and 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21689234Fisher 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.
- Background: PubMed 24374513Van 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.
- Elkins Pancreas CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Fisher, MD principal investigator
Baylor College of Medicine
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Drains and Drains in people with Pancreas Tumor and Pancreatitis, run by Baylor College of Medicine at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-day ≥ Grade II Complication Rate (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01441492, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.