Postoperative Pancreatic Fistula Post-pancreatoduodenectomyNCT06855888
Comparison of Three-sided and Single-sided Mattress Pancreaticojejunostomy in Pancreatoduodenectomy
A study testing Modified Blumgart suture method and Three-sided mattress suture in people with Postoperative Pancreatic Fistula Post-pancreatoduodenectomy, run by Tokai University at 1 site in Japan.
Trial summary
In pancreaticojejunostomy following pancreaticoduodenectomy for soft pancreas, a randomized controlled trial will be conducted to compare a patient group using the conventional Blumgart modified technique and a patient group in which mattress sutures are added to the cranial and caudal sides of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pancreatic Fistula Post-pancreatoduodenectomy
- What is being tested?
- Modified Blumgart suture method and Three-sided mattress suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- 10 Dec 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients scheduled for pancreaticoduodenectomy who have been determined to have a soft pancreas.
- Preoperative CT images show that the pancreatic duct diameter at the planned site of pancreatic resection is 5mm or less.
- ECOG Performance Status (PS) is 0-1.
- Age 18 years or older.
- Function of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) is maintained.
- Patients have sufficient judgment to understand the content of the research, and written consent has been obtained from the individual.
Who cannot join
- Patients with severe ischemic heart disease
- Patients with liver cirrhosis or active hepatitis
- Patients with respiratory distress requiring oxygen due to interstitial pneumonia or pulmonary fibrosis
- Patients undergoing dialysis due to chronic renal failure
- Patients requiring combined resection of surrounding organs
- Patients requiring arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc.
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- Patients with active duplicate cancers that may affect adverse events or overall survival
- Patients taking oral steroids for a long period that may affect adverse events
- Patients with insufficient decision-making ability
- Other subjects deemed inappropriate by the principal investigator or investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Three-sided and Single-sided Mattress Pancreaticojejunostomy in Pancreatoduodenectomy -Randomized Controlled Trial-
In pancreaticojejunostomy following pancreaticoduodenectomy for soft pancreas, a randomized controlled trial will be conducted to compare a patient group using the conventional Blumgart modified technique and a patient group in which mattress sutures are added to the cranial and caudal sides of the pancreaticojejunostomy after the Blumgart modified technique (three-sided mattress suture technique), and to evaluate the safety and usefulness of the three-sided mattress suture technique by comparing the incidence of pancreatic fistula (ISGPF grade B or C).
Read the detailed description
Pancreatoduodenectomy (PD) is one of the most difficult and invasive surgeries, with a 30-50% complication rate even at high volume centers. In particular, if a postoperative pancreatic fistula (POPF), a failure of the pancreaticojejunostomy (PJ) suture, occurs, pancreatic juice containing powerful digestive enzymes leaks into the abdominal cavity, which can develop into serious complications such as intraperitoneal abscesses and postpancreatectomy hemorrhage. To reduce the incidence of POPF post-PD, many clinical studies have been reported on PJ methods. Currently, the original/modified Blumgart method is widely used as an anastomosis technique with relatively good results, but the incidence of International Study Group for Pancreatic Surgery (ISGPS) criteria grade B/C is still around 10-20%. In particular, the incidence of POPF grade B/C in normal soft pancreases with preserved pancreatic function is high at approximately 20-40%, and it is known to be a higher risk than the atrophied, sclerosing pancreas after pancreatitis (incidence rate of approximately 0-10%), and there is still room for improvement in the PJ technique. Therefore, the current clinical problem to be solved in PD is "PJ for the soft pancreas," and reducing the incidence of POPF is thought to be extremely beneficial for patients.
In recent years, it has been reported that the incidence of pseudoaneurysm increases significantly when POPF is found on the superior side of the PJ, and that the incidence of deep surgical site infection increases when POPF occurs on the inferior side of the anastomosis. In the Blumgart method, ventral and dorsal sides of the pancreatic stump are covered by the jejunal wall, but a weak point remains where the jejunal wall does not completely cover the superior and inferior sides of the PJ anastomosis. Therefore, the investigators created a three-sided mattress suture method to eliminate weak gaps by adding mattress sutures between the pancreas and jejunum on the superior and inferior sides of the PJ anastomosis to reduce the incidence of grades B/C POPF.
Prior to this study, the investigators conducted a pilot study in which a three-sided mattress suture was performed for PJ following pylorus-resecting PD in 10 consecutive patients with soft pancreases, and no case of POPF ISGPF grade B/C was observed (incidence rate 0%). The Three-sided mattress method is original, and no randomized controlled trial has proven that this novel method contributes to improving the incidence of POPF post-PD. In this study, the investigators conducted a randomized controlled phase II trial comparing the three-sided mattress suture method with the conventional modified Blumgart suture method, with the aim of proving the effectiveness of this original suture method by examining the incidence of POPF grade B/C. If the usefulness of the three-sided mattress suture method is proven in this study, it is expected to have a major impact as a safer PJ method in PD.
- Being tested
- Modified Blumgart suture method, Three-sided mattress suture
- Keywords
- mattress suture, pancreaticojejunostomy, pancreatoduodenectomy, postoperative pancreatic fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Blumgart suture methodProcedure or surgery
During pancreaticoduodenectomy, the modified Blumgart suture method is used for pancreaticojejunostomy. For anastomosis, 5-0PDS is used for pancreatic duct mucosal anastomosis, and 3-0 or 4-0 monofilament non-absorbable suture is used for pancreaticojejunal mattress anastomosis.
Three-sided mattress sutureProcedure or surgery
At the time of pancreaticoduodenectomy, the three-sided mattress suture is used as the pancreaticojejunostomy method. In addition to the conventional Blumgart modified suture, the three-sided mattress suture method adds a mattress anastomosis with 3-0 or 4-0 monofilament non-absorbable suture to the cranial and caudal sides of the pancreaticojejunostomy site.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Modified Blumgart suture method (conventional treatment group) | Placebo comparator | Not described Receives: Procedure: Modified Blumgart suture method |
| Group B: Three-sided mattress suture (test treatment group) | Active comparator | Not described Receives: Procedure: Three-sided mattress suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic fistula ISGPF grade B or C
Measured: Up to 90 days after surgery
Secondary outcomes (1)
Incidence of postoperative complications, incidence of remnant pancreatitis
Measured: Up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start10 Dec 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pancreatic Fistula Post-pancreatoduodenectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken-ichi Okada, Tokai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855888
- Sponsor's protocol ID
- 24R128
- Other IDs
- UMIN000056623
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three-sided and Single-sided Mattress Pancreaticojejunostomy in Pancreatoduodenectomy -Randomized Controlled Trial-
- ClinicalTrials.gov ID
- NCT06855888
- Acronym / sponsor ID
- 24R128
- Keywords
- mattress suture, pancreaticojejunostomy, pancreatoduodenectomy, postoperative pancreatic fistula
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tokai UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Mar 2025 (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.
In pancreaticojejunostomy following pancreaticoduodenectomy for soft pancreas, a randomized controlled trial will be conducted to compare a patient group using the conventional Blumgart modified technique and a patient group in which mattress sutures are added to the cranial and caudal sides of the pancreaticojejunostomy after the Blumgart modified technique (three-sided mattress suture technique), and to evaluate the safety and usefulness of the three-sided mattress suture technique by comparing the incidence of pancreatic fistula (ISGPF grade B or C).
Detailed description
Pancreatoduodenectomy (PD) is one of the most difficult and invasive surgeries, with a 30-50% complication rate even at high volume centers. In particular, if a postoperative pancreatic fistula (POPF), a failure of the pancreaticojejunostomy (PJ) suture, occurs, pancreatic juice containing powerful digestive enzymes leaks into the abdominal cavity, which can develop into serious complications such as intraperitoneal abscesses and postpancreatectomy hemorrhage. To reduce the incidence of POPF post-PD, many clinical studies have been reported on PJ methods. Currently, the original/modified Blumgart method is widely used as an anastomosis technique with relatively good results, but the incidence of International Study Group for Pancreatic Surgery (ISGPS) criteria grade B/C is still around 10-20%. In particular, the incidence of POPF grade B/C in normal soft pancreases with preserved pancreatic function is high at approximately 20-40%, and it is known to be a higher risk than the atrophied, sclerosing pancreas after pancreatitis (incidence rate of approximately 0-10%), and there is still room for improvement in the PJ technique. Therefore, the current clinical problem to be solved in PD is "PJ for the soft pancreas," and reducing the incidence of POPF is thought to be extremely beneficial for patients.
In recent years, it has been reported that the incidence of pseudoaneurysm increases significantly when POPF is found on the superior side of the PJ, and that the incidence of deep surgical site infection increases when POPF occurs on the inferior side of the anastomosis. In the Blumgart method, ventral and dorsal sides of the pancreatic stump are covered by the jejunal wall, but a weak point remains where the jejunal wall does not completely cover the superior and inferior sides of the PJ anastomosis. Therefore, the investigators created a three-sided mattress suture method to eliminate weak gaps by adding mattress sutures between the pancreas and jejunum on the superior and inferior sides of the PJ anastomosis to reduce the incidence of grades B/C POPF.
Prior to this study, the investigators conducted a pilot study in which a three-sided mattress suture was performed for PJ following pylorus-resecting PD in 10 consecutive patients with soft pancreases, and no case of POPF ISGPF grade B/C was observed (incidence rate 0%). The Three-sided mattress method is original, and no randomized controlled trial has proven that this novel method contributes to improving the incidence of POPF post-PD. In this study, the investigators conducted a randomized controlled phase II trial comparing the three-sided mattress suture method with the conventional modified Blumgart suture method, with the aim of proving the effectiveness of this original suture method by examining the incidence of POPF grade B/C. If the usefulness of the three-sided mattress suture method is proven in this study, it is expected to have a major impact as a safer PJ method in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Modified Blumgart suture method (conventional treatment group) | Placebo comparator | Procedure: Modified Blumgart suture method |
| Group B: Three-sided mattress suture (test treatment group) | Active comparator | Procedure: Three-sided mattress suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for pancreaticoduodenectomy who have been determined to have a soft pancreas.
- Preoperative CT images show that the pancreatic duct diameter at the planned site of pancreatic resection is 5mm or less.
- ECOG Performance Status (PS) is 0-1.
- Age 18 years or older.
- Function of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) is maintained.
Key exclusion criteria (10 listed)
- Patients with severe ischemic heart disease
- Patients with liver cirrhosis or active hepatitis
- Patients with respiratory distress requiring oxygen due to interstitial pneumonia or pulmonary fibrosis
- Patients undergoing dialysis due to chronic renal failure
- Patients requiring combined resection of surrounding organs
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 |
|---|---|---|
| Modified Blumgart suture methodDuring pancreaticoduodenectomy, the modified Blumgart suture method is used for pancreaticojejunostomy. For anastomosis, 5-0PDS is used for pancreatic duct mucosal anastomosis, and 3-0 or 4-0 monofilament non-absorbable suture is used for pancreaticojejunal mattress anastomosis. | Procedure or surgery | Group A: Modified Blumgart suture method (conventional treatment group) |
| Three-sided mattress sutureAt the time of pancreaticoduodenectomy, the three-sided mattress suture is used as the pancreaticojejunostomy method. In addition to the conventional Blumgart modified suture, the three-sided mattress suture method adds a mattress anastomosis with 3-0 or 4-0 monofilament non-absorbable suture to the cranial and caudal sides of the pancreaticojejunostomy site. | Procedure or surgery | Group B: Three-sided mattress suture (test treatment group) |
Primary outcome
Incidence of pancreatic fistula ISGPF grade B or C
Time frame: Up to 90 days after surgery
1 secondary outcome
Incidence of postoperative complications, incidence of remnant pancreatitis
Time frame: Up to 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Blumgart suture method and Three-sided mattress suture in people with Postoperative Pancreatic Fistula Post-pancreatoduodenectomy, run by Tokai University at 1 site in Japan.
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 6 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 4 Mar 2025. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of pancreatic fistula ISGPF grade B or C (time frame: Up to 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2025.