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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Fistula focused on measuring Pancreaticojejunostomy, Duct-to-mucosa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 19, 2022
    Last Updated
    May 24, 2022
    Sponsor
    Assiut University
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    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

    Learn more about this trial

    One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .

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