Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy (PEAPP)

Cairo University (CU)

Status: Unknown

Conditions: Cancer of Pancreas

Treatments: Procedure: Cattell Warren Anastomosis; Procedure: Blumgart Anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05163977

SO2106-31005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Cattell Warren Anastomosis

Active Comparator group

Treatment:

Procedure: Cattell Warren Anastomosis

Blumgart Anastomosis

Experimental group

Treatment:

Procedure: Blumgart Anastomosis