Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy

Cancer of Pancreas Clinical Trial

— PEAPP  

Official title:

Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163977
• Other study ID #: SO2106-31005
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: Ehab A Abdulmaksoud, Master
• Phone: 01099192044
• Email: ehab.a.abdelmaksoud[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

1. Length of hospital stay

2. Post-operative pancreatic fistula

3. ICU admission and stay

4. Operative time

5. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Pancreas
• Pancreatic Neoplasms

Intervention

Procedure:
• Blumgart Anastomosis
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
• Cattell Warren Anastomosis
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

Locations

Country	Name	City	State
Egypt	The Egyptian National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biliary leakage	Any biliary output via percutaneous drains after the first postoperative day, or detected at a re-laparotomy	Up to 10 days after the operation
Secondary	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.	1-3 weeks
Secondary	Hospital Stay	the post operative hospital stay	Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation
Secondary	Operative Time	Time of the surgical procedure in hours	During the operation
Secondary	primary or reactionary hemorrhage	Bleeding that occurs during or in the first day after the operation	During the operation and within the first 24 hours after the operation