Clinical trial NCT05163977: Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy
Official title: Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Pancreas
Keywords: cancer pancreas
pancreatico-jejunostomy
pancreatico-enteric anasomosis
pancreatic anastomosis
post-operative pancreatic fistula
pancreaticoduodenectomy
whipple's procedure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

  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.

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.

Primary outcomes:
measure: Post-Operative Pancreatic Fistula
timeFrame: Up to 10 days after the operation
Secondary outcomes:
measure: Biliary leakage
timeFrame: Up to 10 days after the operation
measure: Post-Operative bleeding
timeFrame: 1-3 weeks
measure: Hospital Stay
timeFrame: Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation
measure: Operative Time
timeFrame: During the operation
measure: primary or reactionary hemorrhage
timeFrame: During the operation and within the first 24 hours after the operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Egyptian National Cancer Institute
Study officials:
affiliation: National Cancer Institute Cairo University
name: Ehab A Abdulmaksoud, master
role: PRINCIPAL_INVESTIGATOR
References: