Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy

NCT05163977 | Unknown

• 1 other identifier: SO2106-31005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis.

Conditions

Cancer of Pancreas

Keywords

cancer pancreas; pancreatico-jejunostomy; pancreatico-enteric anasomosis; pancreatic anastomosis; post-operative pancreatic fistula; pancreaticoduodenectomy; whipple's procedure

Outcome Measures

Primary Outcomes (1)

• Post-Operative Pancreatic Fistula

  We used the International Study Group of Pancreatic Fistula (ISGPF) definition which is any measurable pancreatic fluid output after postoperative day 3 (containing more than three times the normal serum amylase level; more than 300 IU/L) with clinical signs of an infection and/or necessitating a change in clinical management.

  Up to 10 days after the operation

Secondary Outcomes (5)

• Biliary leakage

  Up to 10 days after the operation

• Post-Operative bleeding

  1-3 weeks

• Hospital Stay

  Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation

• Operative Time

  During the operation

• primary or reactionary hemorrhage

  During the operation and within the first 24 hours after the operation

Study Arms (2)

Cattell Warren Anastomosis

ACTIVE COMPARATOR

Procedure: Cattell Warren Anastomosis

Blumgart Anastomosis

EXPERIMENTAL

Procedure: Blumgart Anastomosis

Interventions

Blumgart Anastomosis PROCEDURE

The anti-mesenteric border of the jejunal loop proximal to the hepatico-jejunostomy is brought against the pancreatic stump. With the pancreatic stump retracted by the stay sutures, the transected end of pancreatic duct is first identified and secured by means of a blunt tipped probe. Each trans-pancreatic, suture was performed using a single Polydioxanone (PDS) 3 -0 blunt needle. We usually take 4 sutures, 2 on each side of the duct. The process is repeated in the same manner with the remaining sutures which are tightened at the end to approximate the jejunum loop to the stump. A small stab incision is then made at the anti-mesenteric border of the jejunum and a duct to mucosa anastomosis is constructed using an interrupted 5-0 Prolene. The process is completed by placing each of the retained needles through the seromuscular layer of the anterior jejunal wall and each knot is tied over the jejunal wall which is then warped over the cut end of the stump

Blumgart Anastomosis

Cattell Warren Anastomosis PROCEDURE

It is a two layer, interrupted, end to side pancreatico-jejunostomy. First an interrupted sutures between the posterior capsule and the seromuscular layer of the jejunum was constructed using PDS 3-0 , then a duct to mucosa interrupted sutures were taken using PDS 5-0 and finally interrupted sutures between the anterior capsule and the jejunum . The main difference here is that the sutures are taken in a conventional way which is tangential to the pancreatic capsule and parenchyma

Cattell Warren Anastomosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Known Pancreatic head cancer diagnosed radiologically.
• Operable and borderline pancreatic cancer.
• Patients who will undergo upfront surgery and those who received neoadjuvant chemotherapy are included.

You may not qualify if:

• Metastatic patients.
• Locally advanced cases.
• Patients with comorbidities who are unfit for major surgical procedures.
• Patients with very small pancreatic duct where the pancreatic duct can't be identified.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

The Egyptian National Cancer Institute

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ehab A Abdulmaksoud, master

  National Cancer Institute Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehab A Abdulmaksoud, Master

CONTACT

01099192044; ehab.a.abdelmaksoud@cu.edu.eg

Haitham A Othman, MD

CONTACT

01005890222; haitham.fekry@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Surgical Oncology

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: December 20, 2021
• Study Start: June 12, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)