Pancreatic FistulaNCT00889213
An Evaluation of a New Technique Utilizing a Biologic Glue and Tissue Patch to Seal the Cut Edge of the Pancreas Following Removal of the Tail of the Pancreas
A study testing Falciform patch and fibrin glue application and standard pancreatic closure in people with Pancreatic Fistula and Distal Pancreatectomy Complications, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
The purpose of this trial is to determine whether the use of an autologous falciform ligament patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients completing distal pancreatectomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Fistula, Distal Pancreatectomy Complications, Falciform Patch Pancreatic Closure
- What is being tested?
- Falciform patch and fibrin glue application and standard pancreatic closure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completion of a successful distal pancreatectomy with/without splenectomy
- patient must have a pancreatic remnant in place
- there must be a viable falciform ligament for creation of the autologous patch
Who cannot join
- patients undergoing total pancreatectomy
- patients undergoing distal pancreatectomy who have previously completed a right sided resection of the pancreatic head, uncinate and neck
- failure to sign informed consent
- pregnant patients
- patients in whom previous surgery has eliminated the falciform ligament, i.e. previous liver resection
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University Hospitals Case Medical Center
Cleveland, Ohio
Jeffrey M Hardacre, MD, 216-844-7047, jeffrey.hardacre@UHospitals.org
Bridget Ermlich, RN, (216) 844-3602, bridget.ermlich@UHospitals.org
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Ernest L Rosato, M.D., 215-955-8666, ernest.rosato@jefferson.edu
Ernest L Rosato, M.D.
About this study
Official title: A Prospective Randomized Comparison of Pancreatic Stump Closure Techniques Utilizing an Autologous Falciform Patch and Fibrin Glue Compared to Standard Closure Following Distal Pancreatectomy With or Without Splenectomy
The purpose of this trial is to determine whether the use of an autologous falciform ligament patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients completing distal pancreatectomy. The hypothesis for the current trial is: Autologous falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation postoperatively. The primary end point will be the development of pancreatic fistula using the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid on or after postop day #3 with an amylase content greater than three times serum amylase). Secondary end points will include length of postoperative hospital stay, percutaneous intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).
- Conditions
- Pancreatic Fistula, Distal Pancreatectomy Complications, Falciform Patch Pancreatic Closure, Fibrin Glue Pancreatic Closure
- Being tested
- Falciform patch and fibrin glue application, standard pancreatic closure
- Keywords
- pancreatectomy, fistula, fibrin glue, falciform patch, surgery, complications
- Medical subject headings
- Pancreatic Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falciform patch and fibrin glue applicationProcedure or surgery
Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament. Those patients randomized to autologous falciform patch will have the falciform membrane harvested. The falciform patch will be laid over the suture line of the resected pancreatic stump and secured to the pancreatic capsule utilizing #4-0 PDS suture placed at 12, 3, 6, and 9 o'clock positions. Fibrin glue (Vitagel) will be utilized to fill the potential space within this membranous capsule. Fibrin glue will be prepared as per standard instructions. Drains will be placed in the splenic bed and/or adjacent to the stump of the pancreas for postoperative fluid evacuation.
standard pancreatic closureProcedure or surgery
Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament.
| Study group | Role | What they receive |
|---|---|---|
| Patch and glue arm | Experimental | Randomized patients to the patch and glue arm will undergo placement of a falciform ligament tissue patch and fibrin glue to the resection margin of the remnant pancreas following distal pancreatectomy Receives: Procedure: Falciform patch and fibrin glue application |
| stapled /sutured pancreatic closure | Active comparator | Not described Receives: Procedure: standard pancreatic closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic fistula development post distal pancreatectomy
Measured: 30 days post surgery
Secondary outcomes (3)
Morbidity- wound infection,delayed gastric emptying,abscess formation
Measured: 30 day
Mortality
Measured: 30 day
Surgical re-intervention/percutaneous interventions
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernest L Rosato, M.D., Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889213
- Sponsor's protocol ID
- 08D.229
- Status last verified
- Aug 2014
- First submitted
- 27 Apr 2009
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carter TI, Fong ZV, Hyslop T, Lavu H, Tan WP, Hardacre J, Sauter PK, Kennedy EP, Yeo CJ, Rosato EL. A dual-institution randomized controlled trial of remnant closure after distal pancreatectomy: does the addition of a falciform patch and fibrin glue improve outcomes? J Gastrointest Surg. 2013 Jan;17(1):102-9. doi: 10.1007/s11605-012-1963-x. Epub 2012 Jul 14.
PubMed 22798186
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Pancreatic Stump Closure Techniques Utilizing an Autologous Falciform Patch and Fibrin Glue Compared to Standard Closure Following Distal Pancreatectomy With or Without Splenectomy
- ClinicalTrials.gov ID
- NCT00889213
- Acronym / sponsor ID
- 08D.229
- Conditions
- Pancreatic Fistula, Distal Pancreatectomy Complications, Falciform Patch Pancreatic Closure, Fibrin Glue Pancreatic Closure
- Keywords
- pancreatectomy, fistula, fibrin glue, falciform patch, surgery, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine whether the use of an autologous falciform ligament patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients completing distal pancreatectomy. The hypothesis for the current trial is: Autologous falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation postoperatively. The primary end point will be the development of pancreatic fistula using the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid on or after postop day #3 with an amylase content greater than three times serum amylase). Secondary end points will include length of postoperative hospital stay, percutaneous intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patch and glue arm | Experimental | Procedure: Falciform patch and fibrin glue applicationRandomized patients to the patch and glue arm will undergo placement of a falciform ligament tissue patch and fibrin glue to the resection margin of the remnant pancreas following distal pancreatectomy |
| stapled /sutured pancreatic closure | Active comparator | Procedure: standard pancreatic closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- completion of a successful distal pancreatectomy with/without splenectomy
- patient must have a pancreatic remnant in place
- there must be a viable falciform ligament for creation of the autologous patch
Key exclusion criteria (5 listed)
- patients undergoing total pancreatectomy
- patients undergoing distal pancreatectomy who have previously completed a right sided resection of the pancreatic head, uncinate and neck
- failure to sign informed consent
- pregnant patients
- patients in whom previous surgery has eliminated the falciform ligament, i.e. previous liver resection
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 |
|---|---|---|
| Falciform patch and fibrin glue applicationFollowing standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament. Those patients randomized to autologous falciform patch will have the falciform membrane harvested. The falciform patch will be laid over the suture line of the resected pancreatic stump and secured to the pancreatic capsule utilizing #4-0 PDS suture placed at 12, 3, 6, and 9 o'clock positions. Fibrin glue (Vitagel) will be utilized to fill the potential space within this membranous capsule. Fibrin glue will be prepared as per standard instructions. Drains will be placed in the splenic bed and/or adjacent to the stump of the pancreas for postoperative fluid evacuation. | Procedure or surgery | Patch and glue arm |
| standard pancreatic closureFollowing standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament. | Procedure or surgery | stapled /sutured pancreatic closure |
Primary outcome
Pancreatic fistula development post distal pancreatectomy
Time frame: 30 days post surgery
3 secondary outcomes
Morbidity- wound infection,delayed gastric emptying,abscess formation
Time frame: 30 day
Mortality
Time frame: 30 day
Surgical re-intervention/percutaneous interventions
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Derived from this study: PubMed 22798186Carter TI, Fong ZV, Hyslop T, Lavu H, Tan WP, Hardacre J, Sauter PK, Kennedy EP, Yeo CJ, Rosato EL. A dual-institution randomized controlled trial of remnant closure after distal pancreatectomy: does the addition of a falciform patch and fibrin glue improve outcomes? J Gastrointest Surg. 2013 Jan;17(1):102-9. doi: 10.1007/s11605-012-1963-x. Epub 2012 Jul 14.
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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.
Ernest L Rosato, M.D. principal investigator
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falciform patch and fibrin glue application and standard pancreatic closure in people with Pancreatic Fistula and Distal Pancreatectomy Complications, run by Thomas Jefferson University at 2 sites in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ernest L. Rosato, M.D. (215-955-8666, ernest.rosato@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic fistula development post distal pancreatectomy (time frame: 30 days post surgery). 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 NCT00889213, which also lists 1 linked publication.
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 6 Aug 2014.