Pancreatic FistulaNCT03671031
Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy
An observational study of Pancreatic Fistula, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50%… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- isolated roux loop and single loop
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2009to 30 Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent pancreaticoduodenectomy at General Surgery Clinic in Inonu University between January 2009 and June 2018
Who may be able to join
- patients who underwent pancreaticoduodenectomy.
Who cannot join
- patients with missing data
- patients who underwent total pancreatectomy
- patients who had pancreaticogastrostomy as the reconstruction method
- patients who had emergency pancreaticoduodenectomy
Trial locations and contacts
1 site in 1 country.
About this study
Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8).
In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.
- Conditions
- Pancreatic Fistula
- Being tested
- isolated roux loop, single loop
- Keywords
- pancreatic fistula, pancreatic leak, whipple operation, roux-en-y
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolated roux loopProcedure or surgery
Isolated roux loop reconstruction following pancreaticoduodenectomy
single loopProcedure or surgery
Conventional single loop reconstruction following pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| isolated roux loop | isolated roux loop reconstruction following pancreaticoduodenectomy as the first group. Receives: Procedure: isolated roux loop | |
| single loop | single loop reconstruction following pancreaticoduodenectomy as the second group. Receives: Procedure: single loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of postoperative pancreatic fistula
Assessed according to International Study Group on Pancreatic Fistula definition
Measured: 1 week
Secondary outcomes (5)
Rate of postoperative pancreatic fistula
Number of participants with postoperative pancreatic fistula
Measured: 1 week
Operation time
in minutes
Measured: 1 week
Duration of hospital stay
in days
Measured: 1 week
Duration of intensive care unit stay
in days
Measured: 1 week
30-day mortality
Number of participants died in 30 days after operation
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Jan 2009
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Egemen Ozdemir, Inonu University
- Investigators
- Egemen Ozdemir, MD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671031
- Sponsor's protocol ID
- 2018/16-22
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. doi: 10.3748/wjg.v11.i16.2456.
PubMed 15832417El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.
PubMed 23494109Reid-Lombardo KM, Farnell MB, Crippa S, Barnett M, Maupin G, Bassi C, Traverso LW; Pancreatic Anastomotic Leak Study Group. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients: a report from the Pancreatic Anastomotic Leak Study Group. J Gastrointest Surg. 2007 Nov;11(11):1451-8; discussion 1459. doi: 10.1007/s11605-007-0270-4. Epub 2007 Aug 21.
PubMed 17710506Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Buchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. doi: 10.1016/j.amjsurg.2006.10.010.
PubMed 17236843Xiong JJ, Altaf K, Mukherjee R, Huang W, Hu WM, Li A, Ke NW, Liu XB. Systematic review and meta-analysis of outcomes after intraoperative pancreatic duct stent placement during pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1050-61. doi: 10.1002/bjs.8788. Epub 2012 May 24.
PubMed 22622664Machado MC, da Cunha JE, Bacchella T, Bove P. A modified technique for the reconstruction of the alimentary tract after pancreatoduodenectomy. Surg Gynecol Obstet. 1976 Aug;143(2):271-2.
PubMed 941087Kingsnorth AN. Safety and function of isolated Roux loop pancreaticojejunostomy after Whipple's pancreaticoduodenectomy. Ann R Coll Surg Engl. 1994 May;76(3):175-9.
PubMed 7912489Albertson DA. Pancreaticoduodenectomy with reconstruction by Roux-en-Y pancreaticojejunostomy: no operative mortality in a series of 25 cases. South Med J. 1994 Feb;87(2):197-201. doi: 10.1097/00007611-199402000-00010.
PubMed 8115883
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT03671031
- Acronym / sponsor ID
- 2018/16-22
- Conditions
- Pancreatic Fistula
- Keywords
- pancreatic fistula, pancreatic leak, whipple operation, roux-en-y
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Sep 2018 (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.
Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8).
In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isolated roux loop | – | Procedure: isolated roux loopisolated roux loop reconstruction following pancreaticoduodenectomy as the first group. |
| single loop | – | Procedure: single loopsingle loop reconstruction following pancreaticoduodenectomy as the second group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent pancreaticoduodenectomy at General Surgery Clinic in Inonu University between January 2009 and June 2018
Key inclusion criteria (1 listed)
- patients who underwent pancreaticoduodenectomy.
Key exclusion criteria (4 listed)
- patients with missing data
- patients who underwent total pancreatectomy
- patients who had pancreaticogastrostomy as the reconstruction method
- patients who had emergency pancreaticoduodenectomy
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 |
|---|---|---|
| isolated roux loopIsolated roux loop reconstruction following pancreaticoduodenectomy | Procedure or surgery | isolated roux loop |
| single loopConventional single loop reconstruction following pancreaticoduodenectomy | Procedure or surgery | single loop |
Primary outcome
Severity of postoperative pancreatic fistula
Time frame: 1 week
Assessed according to International Study Group on Pancreatic Fistula definition
5 secondary outcomes
Rate of postoperative pancreatic fistula
Time frame: 1 week
Operation time
Time frame: 1 week
Duration of hospital stay
Time frame: 1 week
Duration of intensive care unit stay
Time frame: 1 week
30-day mortality
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Background: PubMed 15832417Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. doi: 10.3748/wjg.v11.i16.2456.
- Background: PubMed 23494109El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.
- Background: PubMed 17710506Reid-Lombardo KM, Farnell MB, Crippa S, Barnett M, Maupin G, Bassi C, Traverso LW; Pancreatic Anastomotic Leak Study Group. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients: a report from the Pancreatic Anastomotic Leak Study Group. J Gastrointest Surg. 2007 Nov;11(11):1451-8; discussion 1459. doi: 10.1007/s11605-007-0270-4. Epub 2007 Aug 21.
- Background: PubMed 17236843Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Buchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. doi: 10.1016/j.amjsurg.2006.10.010.
- Background: PubMed 22622664Xiong JJ, Altaf K, Mukherjee R, Huang W, Hu WM, Li A, Ke NW, Liu XB. Systematic review and meta-analysis of outcomes after intraoperative pancreatic duct stent placement during pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1050-61. doi: 10.1002/bjs.8788. Epub 2012 May 24.
- Background: PubMed 941087Machado MC, da Cunha JE, Bacchella T, Bove P. A modified technique for the reconstruction of the alimentary tract after pancreatoduodenectomy. Surg Gynecol Obstet. 1976 Aug;143(2):271-2.
- Background: PubMed 7912489Kingsnorth AN. Safety and function of isolated Roux loop pancreaticojejunostomy after Whipple's pancreaticoduodenectomy. Ann R Coll Surg Engl. 1994 May;76(3):175-9.
- Background: PubMed 8115883Albertson DA. Pancreaticoduodenectomy with reconstruction by Roux-en-Y pancreaticojejunostomy: no operative mortality in a series of 25 cases. South Med J. 1994 Feb;87(2):197-201. doi: 10.1097/00007611-199402000-00010.
- 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.
Egemen Ozdemir, MD principal investigator
Inonu University
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, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 25 Sep 2018. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Severity of postoperative pancreatic fistula (time frame: 1 week). 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 NCT03671031, which also lists 8 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 25 Sep 2018.