Pancreatic FistulaNCT04798560
Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
An observational study of Pancreatic Fistula and Whipple Operation, run by Dimitrios Vouros at 1 site in Greece.
Trial summary
Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques. Surgery is the only therapeutic option with an intend to treat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fistula, Whipple Operation, Pancreaticoduodenectomy
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 10 Oct 2018to May 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients over 18 years of age with imaging findings or histologically proven periampullary tumors requiring pancreaticoduodenectomy
Who may be able to join
- Age more than or equal to 18 years
- periampullary pathologies (benign or malignant) with indication for panceaticoduodenectomy
- Pancreaticojejunal anastomosis performed
- Curative resection
- Signed informed consent form -
Who cannot join
- Age less than 18 years old
- One stage total pancreatectomy
- External wirsungostomy without pancreaticojejunal anastomosis
- Subtotal pancreatectomy without pancreaticojejunal anastomosis
- Left pancreatectomies
- Intraoperatively findings of unresectable tumors
- Pregnancy
- Concurrent participation in other study(ies)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
1st Propaedeutic Department of Surgery, Hippokrateion General Hospital
Athens, Attica, 11527
About this study
Official title: Risk Factors for Pancreaticojejunostomy Leakage Following Whipple Operation
Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques. Surgery is the only therapeutic option with an intend to treat. Pancreaticoduodenectomy is indicated for malignancy in the pancreatic head as well as other periampullary tumors. One of the most fatal complications after Whipple operation is postoperative pancreatic fistula as a result of pancreatojejunostomy leakage. Various risk factors for pancreatojejunostomy leakage have been proposed, while there are others less studied.
Read the detailed description
This is a prospective observational study conducted in the 1st Propaedeutic Department of Surgery of the National and Kapodistrian University of Athens, Greece. Patients with imaging and/or histologically proven periampullary tumors in which Whipple operation is indicated will be enrolled in the study after signing a consent designed by the Hospitals Ethics Commitee and the Department of Surgery. Patients information and medical history will be recorded, giving emphasis on clinical presentation, signs and symptoms related to the patients disease. Laboratory tests will afterwards take place, including biochemical parameters such as total bilirubin levels, serum albumin, CA 19-9, CEA, HbA1c and ferritine levels prior to operation. During operation, as soon as the specimen has been removed, the horizontal and vertical dimension of the pancreatic cutting surface will be measured with the use of an one use sterile ruler and the area of the cutting surface will then be calculated as well as the ratio of the two dimensions (horizontal/vertical). The diameter of the pancreatic duct will be measured either with the same ruler in case diameter is equal or greater than 3mm or with a use of a plastic stent in case diameter is less than 3mm. Pancreatic texture will also be assesed. Other intraoperative datas will be recorded such as the anastomosis technique, duration of surgery, amount of fluid administration, transfusion with fresh frosen plasma or blood units.Postoperatively, amylase from the drains, white blood cell count, platelet count and serum crp levels will be recorded on the 1st, 3rd and 5th postoperative day in all patients. The definition used for postoperative pancreatic fistula (POPF) is based on the International Study Group of Pancreatic Fistula 2016 definition and patients will be categorised accordingly. There will be two arms of patients. The first arm will include patients with either no POPF or Biochemical Leak (BL) and the second arm patients with Grade B or C POPF.
Any complication in the early postoperative period ,defined as the first 30 days after Whipple operation, will be recorded and categorised according to Clavien Dindo classification, including reoperation, readmissions or prolongation of hospital stay. After discharge, follow up of the patients include the EORTC QLQ-C30 and EORTC QLQ-PAN 26 questionnaires that patients have to fill in one, three, six and twelve months after surgery. Reccurence and survival rates will accordingly be recorded.
- Conditions
- Pancreatic Fistula, Whipple Operation, Pancreaticoduodenectomy, POPF
- Being tested
- Pancreaticoduodenectomy
- Keywords
- pancreaticoduodenectomy, pancreatic cancer, pancreatic adenocarcinoma
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyProcedure or surgery
Patients udergo pancreaticoduodenectomy for periampullary tumors. All of them are observed for developing POPF
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Whipple operation | After Whipple operation patients will be observed for complications and emphasis will be given on the presence of postoperative pancreatic fistula (POPF) according to the ISGPF 2016 definition. There will be to arms of patients. The first will include patients that do not develop POPF or either develop Biochemical Leak (Grade A). The second group consist of patients that develop either Grade B or Grade C POPF Receives: Procedure: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Postoperative pancreatic fistula after pancreaticoduodenectomy
Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition
Measured: 30 days
Secondary outcomes (7)
Mortality
Mortality rates expressed in % of the patients
Measured: 30 days
Morbidity
Morbidity rates expressed in % of the patients
Measured: 30 days
Postoperative complications
Complications classified according to Clavien-Dindo Classification taking measures from I up to V
Measured: 30 days
Duration of Hospital stay
Duration of Hospital stay in days
Measured: 60 days
Readmission
Readmission rates expressed in % of the patients
Measured: 30 days
Reoperation
Reoperation rates expressed in % of the patients
Measured: 30 days
Overall survival
Estimation of days from operation until death expressed in days
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start10 Oct 2018
- Primary completionApr 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Dimitrios Vouros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dimitrios Vouros, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798560
- Sponsor's protocol ID
- 8515/31-05-2019
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
PubMed 16003309Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PubMed 28040257Cullen JJ, Sarr MG, Ilstrup DM. Pancreatic anastomotic leak after pancreaticoduodenectomy: incidence, significance, and management. Am J Surg. 1994 Oct;168(4):295-8. doi: 10.1016/s0002-9610(05)80151-5.
PubMed 7524375Denbo JW, Orr WS, Zarzaur BL, Behrman SW. Toward defining grade C pancreatic fistula following pancreaticoduodenectomy: incidence, risk factors, management and outcome. HPB (Oxford). 2012 Sep;14(9):589-93. doi: 10.1111/j.1477-2574.2012.00486.x. Epub 2012 May 28.
PubMed 22882195Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018.
PubMed 29588609Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Sep 11;371(11):1039-49. doi: 10.1056/NEJMra1404198. No abstract available.
PubMed 25207767
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Pancreaticojejunostomy Leakage Following Whipple Operation
- ClinicalTrials.gov ID
- NCT04798560
- Acronym / sponsor ID
- 8515/31-05-2019
- Conditions
- Pancreatic Fistula, Whipple Operation, Pancreaticoduodenectomy, POPF
- Keywords
- pancreaticoduodenectomy, pancreatic cancer, pancreatic adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dimitrios VourosUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 15 Mar 2021 (actual)
- 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.
Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques. Surgery is the only therapeutic option with an intend to treat. Pancreaticoduodenectomy is indicated for malignancy in the pancreatic head as well as other periampullary tumors. One of the most fatal complications after Whipple operation is postoperative pancreatic fistula as a result of pancreatojejunostomy leakage. Various risk factors for pancreatojejunostomy leakage have been proposed, while there are others less studied.
Detailed description
This is a prospective observational study conducted in the 1st Propaedeutic Department of Surgery of the National and Kapodistrian University of Athens, Greece. Patients with imaging and/or histologically proven periampullary tumors in which Whipple operation is indicated will be enrolled in the study after signing a consent designed by the Hospitals Ethics Commitee and the Department of Surgery. Patients information and medical history will be recorded, giving emphasis on clinical presentation, signs and symptoms related to the patients disease. Laboratory tests will afterwards take place, including biochemical parameters such as total bilirubin levels, serum albumin, CA 19-9, CEA, HbA1c and ferritine levels prior to operation. During operation, as soon as the specimen has been removed, the horizontal and vertical dimension of the pancreatic cutting surface will be measured with the use of an one use sterile ruler and the area of the cutting surface will then be calculated as well as the ratio of the two dimensions (horizontal/vertical). The diameter of the pancreatic duct will be measured either with the same ruler in case diameter is equal or greater than 3mm or with a use of a plastic stent in case diameter is less than 3mm. Pancreatic texture will also be assesed. Other intraoperative datas will be recorded such as the anastomosis technique, duration of surgery, amount of fluid administration, transfusion with fresh frosen plasma or blood units.Postoperatively, amylase from the drains, white blood cell count, platelet count and serum crp levels will be recorded on the 1st, 3rd and 5th postoperative day in all patients. The definition used for postoperative pancreatic fistula (POPF) is based on the International Study Group of Pancreatic Fistula 2016 definition and patients will be categorised accordingly. There will be two arms of patients. The first arm will include patients with either no POPF or Biochemical Leak (BL) and the second arm patients with Grade B or C POPF.
Any complication in the early postoperative period ,defined as the first 30 days after Whipple operation, will be recorded and categorised according to Clavien Dindo classification, including reoperation, readmissions or prolongation of hospital stay. After discharge, follow up of the patients include the EORTC QLQ-C30 and EORTC QLQ-PAN 26 questionnaires that patients have to fill in one, three, six and twelve months after surgery. Reccurence and survival rates will accordingly be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Whipple operation | – | Procedure: PancreaticoduodenectomyAfter Whipple operation patients will be observed for complications and emphasis will be given on the presence of postoperative pancreatic fistula (POPF) according to the ISGPF 2016 definition. There will be to arms of patients. The first will include patients that do not develop POPF or either develop Biochemical Leak (Grade A). The second group consist of patients that develop either Grade B or Grade C POPF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 18 years of age with imaging findings or histologically proven periampullary tumors requiring pancreaticoduodenectomy
Key inclusion criteria (5 listed)
- Age more than or equal to 18 years
- periampullary pathologies (benign or malignant) with indication for panceaticoduodenectomy
- Pancreaticojejunal anastomosis performed
- Curative resection
- Signed informed consent form -
Key exclusion criteria (8 listed)
- Age less than 18 years old
- One stage total pancreatectomy
- External wirsungostomy without pancreaticojejunal anastomosis
- Subtotal pancreatectomy without pancreaticojejunal anastomosis
- Left pancreatectomies
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 |
|---|---|---|
| PancreaticoduodenectomyPatients udergo pancreaticoduodenectomy for periampullary tumors. All of them are observed for developing POPF | Procedure or surgery | Patients undergoing Whipple operation |
Primary outcome
Development of Postoperative pancreatic fistula after pancreaticoduodenectomy
Time frame: 30 days
Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition
7 secondary outcomes
Mortality
Time frame: 30 days
Morbidity
Time frame: 30 days
Postoperative complications
Time frame: 30 days
Duration of Hospital stay
Time frame: 60 days
Readmission
Time frame: 30 days
Reoperation
Time frame: 30 days
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 16003309Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
- Background: PubMed 28040257Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- Background: PubMed 7524375Cullen JJ, Sarr MG, Ilstrup DM. Pancreatic anastomotic leak after pancreaticoduodenectomy: incidence, significance, and management. Am J Surg. 1994 Oct;168(4):295-8. doi: 10.1016/s0002-9610(05)80151-5.
- Background: PubMed 22882195Denbo JW, Orr WS, Zarzaur BL, Behrman SW. Toward defining grade C pancreatic fistula following pancreaticoduodenectomy: incidence, risk factors, management and outcome. HPB (Oxford). 2012 Sep;14(9):589-93. doi: 10.1111/j.1477-2574.2012.00486.x. Epub 2012 May 28.
- Background: PubMed 29588609Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018.
- Background: PubMed 25207767Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Sep 11;371(11):1039-49. doi: 10.1056/NEJMra1404198. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Fistula and Whipple Operation, run by Dimitrios Vouros at 1 site in Greece.
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 8 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 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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 Dimitrios Vouros, MD, MSc (+30 2132088142, jimsamiotis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Postoperative pancreatic fistula after pancreaticoduodenectomy (time frame: 30 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 NCT04798560, which also lists 6 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 15 Mar 2021.