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

NCT05387538 | Unknown

• 1 other identifier: HF2022
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Fistula

Keywords

Pancreaticojejunostomy; Duct-to-mucosa

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (2)

• Duration of postoperative hospital stay

  30 days

• anastomosis time

  1 hour

Study Arms (2)

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.

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.

Procedure: Two-layer Duct-to-mucosa Pancreaticojejunostomy

Interventions

One-layer Duct-to-mucosa Pancreaticojejunostomy PROCEDURE

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

One-layer Duct-to-mucosa Pancreaticojejunostomy

Two-layer Duct-to-mucosa Pancreaticojejunostomy PROCEDURE

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.

Two-layer Duct-to-mucosa Pancreaticojejunostomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female, aged 18 to 65. Patients scheduled to undergo pancreaticoduodenectomy.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Abd El-moniem I.M El-khateeb, professor

  Faculty of medicine_Assuit university_Assuit_ Egypt

  STUDY CHAIR

Central Study Contacts

Hamada F Ahmed, MD

CONTACT

0109801096; dr.hamada2139@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at general surgery department

Model Details: 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

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: May 30, 2022
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 27, 2022

Record last verified: 2022-05