search
Back to results

Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy (PEAPP)

Primary Purpose

Cancer of Pancreas

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Blumgart Anastomosis
Cattell Warren Anastomosis
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Pancreas focused on measuring cancer pancreas, pancreatico-jejunostomy, pancreatico-enteric anasomosis, pancreatic anastomosis, post-operative pancreatic fistula, pancreaticoduodenectomy, whipple's procedure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Egyptian National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cattell Warren Anastomosis

Blumgart Anastomosis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Biliary leakage
Any biliary output via percutaneous drains after the first postoperative day, or detected at a re-laparotomy
Post-Operative bleeding
including early and late bleeding (1-3 weeks post-operative) According to ISGPF it is defined as any bleeding from the surgical site with a drop in hemoglobin concentration greater than 3 g/dL with peripheral circulatory impairment requiring medical, surgical, or radiological intervention.
Hospital Stay
the post operative hospital stay
Operative Time
Time of the surgical procedure in hours
primary or reactionary hemorrhage
Bleeding that occurs during or in the first day after the operation

Full Information

First Posted
July 13, 2021
Last Updated
December 5, 2021
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05163977
Brief Title
Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy
Acronym
PEAPP
Official Title
Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
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.
Detailed Description
Study Design This study is a randomized prospective clinical trial. Methods of randomization: Randomized block design The objective of the study was to evaluate the effect of Blumgart anastomosis versus Cattell Warren techniques for pancreatico-jejunostomy regarding Surgical technique Peri-operative outcome including Length of hospital stay Post-operative pancreatic fistula ICU admission and stay Operative time Other morbidity and mortality Data collection: All data will be collected for each group and will be divided into Patients' factors, intraoperative and postoperative factors. Patients' factors include patients' demographics, co-morbidities, neoadjuvant treatment, Pathology and Biliary drainage. Intra-operative factors include type of Pancreaticoduodenectomy (PD) (Whether classic or PPPD), Operative time in hours and estimated blood loss in ml, pancreatic duct and texture of pancreas. Post-operative factors include the short term post-operative course which will be divided into specific complications (pancreatic leakage, biliary leakage, delayed gastric emptying, 2ry hemorrhage, intra-abdominal collection, deep wound infection, Portal Vein (PV) - Superior Mesenteric Vein (SMV) thrombosis and general surgical complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas
Keywords
cancer pancreas, pancreatico-jejunostomy, pancreatico-enteric anasomosis, pancreatic anastomosis, post-operative pancreatic fistula, pancreaticoduodenectomy, whipple's procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cattell Warren Anastomosis
Arm Type
Active Comparator
Arm Title
Blumgart Anastomosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Blumgart Anastomosis
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Cattell Warren Anastomosis
Intervention Description
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
Primary Outcome Measure Information:
Title
Post-Operative Pancreatic Fistula
Description
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.
Time Frame
Up to 10 days after the operation
Secondary Outcome Measure Information:
Title
Biliary leakage
Description
Any biliary output via percutaneous drains after the first postoperative day, or detected at a re-laparotomy
Time Frame
Up to 10 days after the operation
Title
Post-Operative bleeding
Description
including early and late bleeding (1-3 weeks post-operative) According to ISGPF it is defined as any bleeding from the surgical site with a drop in hemoglobin concentration greater than 3 g/dL with peripheral circulatory impairment requiring medical, surgical, or radiological intervention.
Time Frame
1-3 weeks
Title
Hospital Stay
Description
the post operative hospital stay
Time Frame
Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation
Title
Operative Time
Description
Time of the surgical procedure in hours
Time Frame
During the operation
Title
primary or reactionary hemorrhage
Description
Bleeding that occurs during or in the first day after the operation
Time Frame
During the operation and within the first 24 hours after the operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehab A Abdulmaksoud, Master
Phone
01099192044
Ext
002
Email
ehab.a.abdelmaksoud@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Haitham A Othman, MD
Phone
01005890222
Ext
002
Email
haitham.fekry@nci.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab A Abdulmaksoud, master
Organizational Affiliation
National Cancer Institute Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Egyptian National Cancer Institute
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy

We'll reach out to this number within 24 hrs