Pancreatic FistulaNCT05682768
Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure
An observational study of Pancreatic Fistula, run by South Valley University at 1 site in Egypt.
Trial summary
Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 25 Dec 2022
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with soft pancreas and pancreatic duct diameter ≤ 5 mm (15 Fr), who underwent the classic pancreaticoduodenectomy (Whipple) procedure for cancer pancreas. Supporting pancreatico-gastrostomy with buttressing sutures was used. It is an anastomotic modification by supporting it with trans-pancreatic and full-thickness gastric wall transverse mattress U- Shaped sutures to fix the posterior gastric wall envelope around the pancreatic stump, to alleviate any tension on the Pancreatico-Gastrostomy sutures.
Who may be able to join
- Patient diagnosed with resectable cancer head pancreas.
- Soft Pancreas.
- Small pancreatic duct diameter.
Who cannot join
- Unresectable cancer pancreas.
- Non soft pancreas.
- Dilated pancreatic duct.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Pancreatic Duct Diameter in Whipple Procedure. A Retrospective Cohort Study
Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.
Read the detailed description
Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.
The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.
- Conditions
- Pancreatic Fistula
- Being tested
- Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures
- Keywords
- Cancer pancreas, Pancreaticoduodenectomy, Pancreaticogastrostomy
- 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.
Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped suturesProcedure or surgery
Also called Buttressing sutures
Adding suporting sutures between th posterior gastric wall and ancreatic stump in whipple procedure, the sutures are Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with cancer pancreas with soft pancreas and non-dilated pancreatic duct Receives: Procedure: Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pancreatic Fistula
Detection of chemical or clinical pancreatic fluid discharge after post-operative day 3.
Measured: up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Jan 2018
- Primary completion30 Nov 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mohamed Taha Aly, South Valley University
- Investigators
- Abdallah M Taha, MD, Principal investigator, South Valley University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682768
- Sponsor's protocol ID
- SVU-MED-SUR011-4-22-10-465
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol Statistical Analysis Plan
Publications
Callery MP, Pratt WB, Vollmer CM Jr. Prevention and management of pancreatic fistula. J Gastrointest Surg. 2009 Jan;13(1):163-73. doi: 10.1007/s11605-008-0534-7. Epub 2008 May 22.
PubMed 18496727Lai EC, Lau SH, Lau WY. Measures to prevent pancreatic fistula after pancreatoduodenectomy: a comprehensive review. Arch Surg. 2009 Nov;144(11):1074-80. doi: 10.1001/archsurg.2009.193.
PubMed 19917946Osada S, Imai H, Sasaki Y, Tanaka Y, Nonaka K, Yoshida K. Reconstruction method after pancreaticoduodenectomy. Idea to prevent serious complications. JOP. 2012 Jan 10;13(1):1-6.
PubMed 22233940Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
PubMed 23122535Schmidt CM, Choi J, Powell ES, Yiannoutsos CT, Zyromski NJ, Nakeeb A, Pitt HA, Wiebke EA, Madura JA, Lillemoe KD. Pancreatic fistula following pancreaticoduodenectomy: clinical predictors and patient outcomes. HPB Surg. 2009;2009:404520. doi: 10.1155/2009/404520. Epub 2009 May 18.
PubMed 19461951Lermite E, Pessaux P, Brehant O, Teyssedou C, Pelletier I, Etienne S, Arnaud JP. Risk factors of pancreatic fistula and delayed gastric emptying after pancreaticoduodenectomy with pancreaticogastrostomy. J Am Coll Surg. 2007 Apr;204(4):588-96. doi: 10.1016/j.jamcollsurg.2007.01.018. Epub 2007 Mar 2.
PubMed 17382217Bassi C, Falconi M, Molinari E, Salvia R, Butturini G, Sartori N, Mantovani W, Pederzoli P. Reconstruction by pancreaticojejunostomy versus pancreaticogastrostomy following pancreatectomy: results of a comparative study. Ann Surg. 2005 Dec;242(6):767-71, discussion 771-3. doi: 10.1097/01.sla.0000189124.47589.6d.
PubMed 16327486
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Pancreatic Duct Diameter in Whipple Procedure. A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05682768
- Acronym / sponsor ID
- SVU-MED-SUR011-4-22-10-465
- Conditions
- Pancreatic Fistula
- Keywords
- Cancer pancreas, Pancreaticoduodenectomy, Pancreaticogastrostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 12 Jan 2023 (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.
Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.
Detailed description
Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.
The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped suturesPatients with cancer pancreas with soft pancreas and non-dilated pancreatic duct |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with soft pancreas and pancreatic duct diameter ≤ 5 mm (15 Fr), who underwent the classic pancreaticoduodenectomy (Whipple) procedure for cancer pancreas. Supporting pancreatico-gastrostomy with buttressing sutures was used. It is an anastomotic modification by supporting it with trans-pancreatic and full-thickness gastric wall transverse mattress U- Shaped sutures to fix the posterior gastric wall envelope around the pancreatic stump, to alleviate any tension on the Pancreatico-Gastrostomy sutures.
Key inclusion criteria (3 listed)
- Patient diagnosed with resectable cancer head pancreas.
- Soft Pancreas.
- Small pancreatic duct diameter.
Key exclusion criteria (3 listed)
- Unresectable cancer pancreas.
- Non soft pancreas.
- Dilated pancreatic duct.
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 |
|---|---|---|
| Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped suturesAlso: Buttressing suturesAdding suporting sutures between th posterior gastric wall and ancreatic stump in whipple procedure, the sutures are Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures. | Procedure or surgery | Patients |
Primary outcome
Post operative Pancreatic Fistula
Time frame: up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)
Detection of chemical or clinical pancreatic fluid discharge after post-operative day 3.
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 12 Jan 2023.
- Background: PubMed 18496727Callery MP, Pratt WB, Vollmer CM Jr. Prevention and management of pancreatic fistula. J Gastrointest Surg. 2009 Jan;13(1):163-73. doi: 10.1007/s11605-008-0534-7. Epub 2008 May 22.
- Background: PubMed 19917946Lai EC, Lau SH, Lau WY. Measures to prevent pancreatic fistula after pancreatoduodenectomy: a comprehensive review. Arch Surg. 2009 Nov;144(11):1074-80. doi: 10.1001/archsurg.2009.193.
- Background: PubMed 22233940Osada S, Imai H, Sasaki Y, Tanaka Y, Nonaka K, Yoshida K. Reconstruction method after pancreaticoduodenectomy. Idea to prevent serious complications. JOP. 2012 Jan 10;13(1):1-6.
- Background: PubMed 23122535Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
- Background: PubMed 19461951Schmidt CM, Choi J, Powell ES, Yiannoutsos CT, Zyromski NJ, Nakeeb A, Pitt HA, Wiebke EA, Madura JA, Lillemoe KD. Pancreatic fistula following pancreaticoduodenectomy: clinical predictors and patient outcomes. HPB Surg. 2009;2009:404520. doi: 10.1155/2009/404520. Epub 2009 May 18.
- Background: PubMed 17382217Lermite E, Pessaux P, Brehant O, Teyssedou C, Pelletier I, Etienne S, Arnaud JP. Risk factors of pancreatic fistula and delayed gastric emptying after pancreaticoduodenectomy with pancreaticogastrostomy. J Am Coll Surg. 2007 Apr;204(4):588-96. doi: 10.1016/j.jamcollsurg.2007.01.018. Epub 2007 Mar 2.
- Background: PubMed 16327486Bassi C, Falconi M, Molinari E, Salvia R, Butturini G, Sartori N, Mantovani W, Pederzoli P. Reconstruction by pancreaticojejunostomy versus pancreaticogastrostomy following pancreatectomy: results of a comparative study. Ann Surg. 2005 Dec;242(6):767-71, discussion 771-3. doi: 10.1097/01.sla.0000189124.47589.6d.
- Individual participant dataSharing planned: No. Study Protocol Statistical Analysis Plan
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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.
Abdallah M Taha, MD principal investigator
South Valley University, Faculty of Medicine
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 South Valley University at 1 site in Egypt.
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 3 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 12 Jan 2023. 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 Egypt. 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?
Post operative Pancreatic Fistula (time frame: up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)). 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 NCT05682768, which also lists 7 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 12 Jan 2023.