One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .
Primary Purpose
Pancreatic Fistula
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One-layer Duct-to-mucosa Pancreaticojejunostomy
Two-layer Duct-to-mucosa Pancreaticojejunostomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Fistula focused on measuring Pancreaticojejunostomy, Duct-to-mucosa
Eligibility Criteria
Inclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
One-layer Duct-to-mucosa Pancreaticojejunostomy
Two-layer Duct-to-mucosa Pancreaticojejunostomy
Arm Description
pancreatic anastomosis to jejunum will be performed in one layer suturing the pancreatic duct to the mucosa of jejunum.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of postoperative hospital stay
Time from day of operation to day of discharge
anastomosis time
anastomosis time was calculated from beginning to the end of pancreaticojejunostomy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05387538
Brief Title
One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .
Official Title
One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy : Randomized Comparative Prospective Study .
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2022 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula
Keywords
Pancreaticojejunostomy, Duct-to-mucosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One-layer Duct-to-mucosa Pancreaticojejunostomy
Arm Type
Experimental
Arm Description
pancreatic anastomosis to jejunum will be performed in one layer suturing the pancreatic duct to the mucosa of jejunum.
Arm Title
Two-layer Duct-to-mucosa Pancreaticojejunostomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
One-layer Duct-to-mucosa Pancreaticojejunostomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Two-layer Duct-to-mucosa Pancreaticojejunostomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pancreatic fistula(POPF) rate
Description
drainage of any measurable volume of fluid with an amylase content >3 times the upper normal serum value on or after postoperative day 3.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Duration of postoperative hospital stay
Description
Time from day of operation to day of discharge
Time Frame
30 days
Title
anastomosis time
Description
anastomosis time was calculated from beginning to the end of pancreaticojejunostomy
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamada F Ahmed, MD
Phone
0109801096
Email
dr.hamada2139@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abd El-moniem I.M El-khateeb, professor
Organizational Affiliation
Faculty of medicine_Assuit university_Assuit_ Egypt
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .
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