Pancreatic FistulaNCT05387538
One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .
A study testing One-layer Duct-to-mucosa Pancreaticojejunostomy and Two-layer Duct-to-mucosa Pancreaticojejunostomy in people with Pancreatic Fistula, run by Assiut University.
Trial summary
Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- One-layer Duct-to-mucosa Pancreaticojejunostomy and Two-layer Duct-to-mucosa Pancreaticojejunostomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2022to 1 Aug 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female, aged 18 to 65. Patients scheduled to undergo pancreaticoduodenectomy.
- Exclusion Criteria:; Patients who had a previous pancreatic operation; Patients with an immunodeficiency.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy : Randomized Comparative Prospective Study .
Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional radiology, and/or reoperation, etc.. Several anastomotic surgical techniques have been developed to reduce the incidence of pancreatic fistula in recent decades, including the duct-to-mucosa method, pancreaticogastrostomy, Peng's binding method, and the "end-to-end" or "end-to-side" invaginated method. Among these techniques, the conventional duct-to-mucosa method remains the most popular anastomosis due to its advantages.
The size of the pancreatic remnant is not limited; moreover, the jejunal lumen and pancreatic remnant lead to easier anastomosis . Compared with two-layer duct-to-mucosa anastomosis, the novel one-layer duct-to-mucosa PJ anastomosis method has been reported to be efficient at reducing POPF occurrence. However, the two cited retrospective studies might lead to selection bias. Because this evidence is insufficient, we will conduct a randomized controlled trial to verify the superiority of one-layer duct-to-mucosa PJ anastomosis after PD over the two-layer technique.
Read the detailed description
To date, pancreaticoduodenectomy (PD) has been regarded as the only potentially curative treatment for pancreatic head and periampullary tumors, including tumors in the ampullary region, distal biliary duct, and periampullary duodenum .
A retrospective study in which 1000 cases were recruited over the past three decades showed that PD has become an effective treatment to reduce hospital mortality. Mortality has been reduced to less than 5 %, but the morbidity remains at 30-50 % .
Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional radiology, and/or reoperation, etc.
POPF risk is increased by many factors including pancreatic texture, main pancreatic duct diameter, and pancreaticojejunal (PJ) anastomotic technique .Among these factors, only anastomotic technique can be improved. According to the International Study Group of Pancreatic Surgery (ISGPS) definition, POPF exists if the drainage of any measurable volume of fluid containing amylase exceeds three times the normal serum value on or after postoperative day (POD) 3.
Several anastomotic surgical techniques have been developed to reduce the incidence of pancreatic fistula in recent decades, including the duct-to-mucosa method, pancreaticogastrostomy, Peng's binding method, and the "end-to-end" or "end-to-side" invaginated method. Among these techniques, the conventional duct-to-mucosa method remains the most popular anastomosis due to its advantages.
The size of the pancreatic remnant is not limited; moreover, the jejunal lumen and pancreatic remnant lead to easier anastomosis .Compared with two-layer duct-to-mucosa anastomosis, the novel one-layer duct-to-mucosa PJ anastomosis method has been reported to be efficient at reducing POPF occurrence . However, the two cited retrospective studies might lead to selection bias. Because this evidence is insufficient, we will conduct a randomized controlled trial to verify the superiority of one-layer duct-to-mucosa PJ anastomosis after PD over the two-layer technique.
- Conditions
- Pancreatic Fistula
- Being tested
- One-layer Duct-to-mucosa Pancreaticojejunostomy, Two-layer Duct-to-mucosa Pancreaticojejunostomy
- Keywords
- Pancreaticojejunostomy, Duct-to-mucosa
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-layer Duct-to-mucosa PancreaticojejunostomyProcedure or surgery
To create the anterior suturing layers, double needles with a 4/0 or 3/0 Prolene line will be used; one side of the needles will be inserted from the anterior inner side of the pancreatic duct and out through the ventral parenchyma of the pancreatic stump to the anterior surface of the pancreas about 3 cm from the cut edge. The other side of the needles will be started from the inner side of the jejunum lumen, then pushed through the subserosa and seromuscular region, and out from the posterior surface of the bowel but its done after completion of the posterior layer. The posterior suturing layer will be treated in the same manner. An internal pancreatic duct stent will be used
Two-layer Duct-to-mucosa PancreaticojejunostomyProcedure or surgery
The same double needle and 4/0 or 3/0Prolene line will be used. First, the region approximately 1.0 cm from the cutting edge of the pancreatic remnant will be freed; then, the posterior surface of the pancreatic remnant will be sutured to the seromuscular layer of the jejunum using the interrupted suturing method. The jejunum will be brought closer to the stump of the pancreas, and a hole of similar diameter to the main pancreatic duct will be made on the jejunum near the entrance of the main pancreatic duct. The posterior wall of the jejunum near the hole will be sutured to the posterior wall of the pancreatic duct using the interrupted suturing method with Prolene line, and a suitable internal pancreatic duct stent will used . The interior side of the jejunum and pancreas will be sutured using the same method. Then, the anterior surface of the pancreatic remnant and the seromuscular layer of the jejunum will be tightly sutured using the interrupted method.
| Study group | Role | What they receive |
|---|---|---|
| One-layer Duct-to-mucosa Pancreaticojejunostomy | Experimental | pancreatic anastomosis to jejunum will be performed in one layer suturing the pancreatic duct to the mucosa of jejunum. Receives: Procedure: One-layer Duct-to-mucosa Pancreaticojejunostomy |
| Two-layer Duct-to-mucosa Pancreaticojejunostomy | Experimental | pancreatic anastomosis to jejunum will be performed in two layer. The first layer will be suturing the pancreatic capsule to the seromuscular layer of jejunum and the 2nd layer will be suturing the pancreatic duct to the mucosa of jejunum. Receives: Procedure: Two-layer Duct-to-mucosa Pancreaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pancreatic fistula(POPF) rate
drainage of any measurable volume of fluid with an amylase content >3 times the upper normal serum value on or after postoperative day 3.
Measured: 30 days
Secondary outcomes (2)
Duration of postoperative hospital stay
Time from day of operation to day of discharge
Measured: 30 days
anastomosis time
anastomosis time was calculated from beginning to the end of pancreaticojejunostomy
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start30 May 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomized into two groups according to the surgical procedure performed as follows group (A )had pts who will undergo One-layer Duct-to-mucosa Pancreaticojejunostomy group(B) had pts who will undergo Two-layer Duct-to-mucosa Pancreaticojejunostomy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hamada, Assiut University
- Investigators
- Abd El-moniem I.M El-khateeb, professor, Study chair, Faculty of medicine_Assuit university_Assuit_ Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387538
- Sponsor's protocol ID
- HF2022
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 27 May 2022
- 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 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy : Randomized Comparative Prospective Study .
- ClinicalTrials.gov ID
- NCT05387538
- Acronym / sponsor ID
- HF2022
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreaticojejunostomy, Duct-to-mucosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 24 May 2022 (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.
Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional radiology, and/or reoperation, etc.. Several anastomotic surgical techniques have been developed to reduce the incidence of pancreatic fistula in recent decades, including the duct-to-mucosa method, pancreaticogastrostomy, Peng's binding method, and the "end-to-end" or "end-to-side" invaginated method. Among these techniques, the conventional duct-to-mucosa method remains the most popular anastomosis due to its advantages.
The size of the pancreatic remnant is not limited; moreover, the jejunal lumen and pancreatic remnant lead to easier anastomosis . Compared with two-layer duct-to-mucosa anastomosis, the novel one-layer duct-to-mucosa PJ anastomosis method has been reported to be efficient at reducing POPF occurrence. However, the two cited retrospective studies might lead to selection bias. Because this evidence is insufficient, we will conduct a randomized controlled trial to verify the superiority of one-layer duct-to-mucosa PJ anastomosis after PD over the two-layer technique.
Detailed description
To date, pancreaticoduodenectomy (PD) has been regarded as the only potentially curative treatment for pancreatic head and periampullary tumors, including tumors in the ampullary region, distal biliary duct, and periampullary duodenum .
A retrospective study in which 1000 cases were recruited over the past three decades showed that PD has become an effective treatment to reduce hospital mortality. Mortality has been reduced to less than 5 %, but the morbidity remains at 30-50 % .
Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional radiology, and/or reoperation, etc.
POPF risk is increased by many factors including pancreatic texture, main pancreatic duct diameter, and pancreaticojejunal (PJ) anastomotic technique .Among these factors, only anastomotic technique can be improved. According to the International Study Group of Pancreatic Surgery (ISGPS) definition, POPF exists if the drainage of any measurable volume of fluid containing amylase exceeds three times the normal serum value on or after postoperative day (POD) 3.
Several anastomotic surgical techniques have been developed to reduce the incidence of pancreatic fistula in recent decades, including the duct-to-mucosa method, pancreaticogastrostomy, Peng's binding method, and the "end-to-end" or "end-to-side" invaginated method. Among these techniques, the conventional duct-to-mucosa method remains the most popular anastomosis due to its advantages.
The size of the pancreatic remnant is not limited; moreover, the jejunal lumen and pancreatic remnant lead to easier anastomosis .Compared with two-layer duct-to-mucosa anastomosis, the novel one-layer duct-to-mucosa PJ anastomosis method has been reported to be efficient at reducing POPF occurrence . However, the two cited retrospective studies might lead to selection bias. Because this evidence is insufficient, we will conduct a randomized controlled trial to verify the superiority of one-layer duct-to-mucosa PJ anastomosis after PD over the two-layer technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- patients will be randomized into two groups according to the surgical procedure performed as follows group (A )had pts who will undergo One-layer Duct-to-mucosa Pancreaticojejunostomy group(B) had pts who will undergo Two-layer Duct-to-mucosa Pancreaticojejunostomy
| Arm | Type | Receives |
|---|---|---|
| One-layer Duct-to-mucosa Pancreaticojejunostomy | Experimental | Procedure: One-layer Duct-to-mucosa Pancreaticojejunostomypancreatic anastomosis to jejunum will be performed in one layer suturing the pancreatic duct to the mucosa of jejunum. |
| Two-layer Duct-to-mucosa Pancreaticojejunostomy | Experimental | Procedure: Two-layer Duct-to-mucosa Pancreaticojejunostomypancreatic anastomosis to jejunum will be performed in two layer. The first layer will be suturing the pancreatic capsule to the seromuscular layer of jejunum and the 2nd layer will be suturing the pancreatic duct to the mucosa of jejunum. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both male and female, aged 18 to 65. Patients scheduled to undergo pancreaticoduodenectomy.
- Exclusion Criteria:; Patients who had a previous pancreatic operation; Patients with an immunodeficiency.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| One-layer Duct-to-mucosa PancreaticojejunostomyTo create the anterior suturing layers, double needles with a 4/0 or 3/0 Prolene line will be used; one side of the needles will be inserted from the anterior inner side of the pancreatic duct and out through the ventral parenchyma of the pancreatic stump to the anterior surface of the pancreas about 3 cm from the cut edge. The other side of the needles will be started from the inner side of the jejunum lumen, then pushed through the subserosa and seromuscular region, and out from the posterior surface of the bowel but its done after completion of the posterior layer. The posterior suturing layer will be treated in the same manner. An internal pancreatic duct stent will be used | Procedure or surgery | One-layer Duct-to-mucosa Pancreaticojejunostomy |
| Two-layer Duct-to-mucosa PancreaticojejunostomyThe same double needle and 4/0 or 3/0Prolene line will be used. First, the region approximately 1.0 cm from the cutting edge of the pancreatic remnant will be freed; then, the posterior surface of the pancreatic remnant will be sutured to the seromuscular layer of the jejunum using the interrupted suturing method. The jejunum will be brought closer to the stump of the pancreas, and a hole of similar diameter to the main pancreatic duct will be made on the jejunum near the entrance of the main pancreatic duct. The posterior wall of the jejunum near the hole will be sutured to the posterior wall of the pancreatic duct using the interrupted suturing method with Prolene line, and a suitable internal pancreatic duct stent will used . The interior side of the jejunum and pancreas will be sutured using the same method. Then, the anterior surface of the pancreatic remnant and the seromuscular layer of the jejunum will be tightly sutured using the interrupted method. | Procedure or surgery | Two-layer Duct-to-mucosa Pancreaticojejunostomy |
Primary outcome
postoperative pancreatic fistula(POPF) rate
Time frame: 30 days
drainage of any measurable volume of fluid with an amylase content >3 times the upper normal serum value on or after postoperative day 3.
2 secondary outcomes
Duration of postoperative hospital stay
Time frame: 30 days
anastomosis time
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- 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. This study is not recruiting at the moment.
Abd El-moniem I.M El-khateeb, professor study chair
Faculty of medicine_Assuit university_Assuit_ Egypt
Questions about this trial
What is this clinical trial studying?
A study testing One-layer Duct-to-mucosa Pancreaticojejunostomy and Two-layer Duct-to-mucosa Pancreaticojejunostomy in people with Pancreatic Fistula, run by Assiut University.
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 2 inclusion and 0 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 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Hamada F Ahmed, MD (0109801096, dr.hamada2139@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pancreatic fistula(POPF) rate (time frame: 30 days). 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 27 May 2022.