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UnknownNCT05163977

Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBlumgart AnastomosisThe 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
PROCEDURECattell Warren AnastomosisIt 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

Timeline

Start date
2021-06-12
Primary completion
2022-12-01
Completion
2022-12-01
First posted
2021-12-20
Last updated
2021-12-20

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05163977. Inclusion in this directory is not an endorsement.