Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy
- Conditions
- Cancer of Pancreas
- Interventions
- Procedure: Blumgart AnastomosisProcedure: Cattell Warren Anastomosis
- Registration Number
- NCT05163977
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blumgart Anastomosis Blumgart Anastomosis - Cattell Warren Anastomosis Cattell Warren Anastomosis -
- Primary Outcome Measures
Name Time Method Post-Operative Pancreatic Fistula Up to 10 days after the operation 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
Name Time Method Post-Operative bleeding 1-3 weeks 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 Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation the post operative hospital stay
Operative Time During the operation Time of the surgical procedure in hours
primary or reactionary hemorrhage During the operation and within the first 24 hours after the operation Bleeding that occurs during or in the first day after the operation
Biliary leakage Up to 10 days after the operation Any biliary output via percutaneous drains after the first postoperative day, or detected at a re-laparotomy
Trial Locations
- Locations (1)
The Egyptian National Cancer Institute
🇪🇬Cairo, Egypt