Clinical Trials Logo

Clinical Trial Summary

Few decades back pancreatico-duodenectomy (PD) was associated with a very high morbidity and mortality. With recent advancements in surgical and anesthetic techniques and improvement in peri-operative care, PD has evolved into a procedure with acceptable morbidity and mortality. Today PD is associated with a mortality of less than 5%, in high volume tertiary care centers. The multimodal concept of fast-track surgery was first introduced in colonic surgery. Several studies have demonstrated the effectiveness of this program in colonic resection. Recently, fast-track surgery has been attempted in pancreatic surgery with encouraging results, but such data are sparse. The core aims of ERAS protocols are to safely hasten postoperative recovery and ease the stress response. Specifically, in the context of pancreatico-duodenectomy, such interventions have been shown to be safe with no increase in mortality or unplanned readmissions, delayed gastric emptying (DGE), or pancreatic fistula . Purported benefits include reduced admission related costs, incidence of DGE, overall morbidity and length of stay. The aim of this study was to evaluate the feasibility of implementing fast track rehabilitation protocol following pancreaticoduodenectomy and to see if it is associated with improved recovery, reduced morbidity and reduced length of hospital stay.


Clinical Trial Description

Study population: This is a prospective study that will be conducted on all patients of both sexes and definite age groups attending the National Cancer Institute, Cairo University and candidate for pancreatico-duodenectomy Sampling: all cases fulfilling the inclusion criteria will be included in the study. Patients will be classified into two groups: - Group A: Fast track Care pancreatico-duodenectomy. - Group B: Conventional Care pancreatico-duodenectomy. Baseline demographics, body mass index (BMI), perioperative parameters, postoperative course, postoperative complications and 30-days operative mortality will be analyzed. Inclusion criteria: - Age ≤ 75 years - ASA 1 or 2 - BMI < 35 The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study Exclusion criteria: - pancreatico-duodenectomy with vascular reconstruction. - Unenthusiastic patients. Type of study: randomized controlled trial The assignment of patients to either group will be done by a random computer-assissted allocation. The allocation will be done by the use of opaque envelopes with assignments. It's an open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors will know which procedure will be done to which patients. Discharge criteria for goup A include; uncomplicated procedure, afebrile patient without tachycardia, tolerance of oral feeding, adequate control of pain with oral analgesia, patient ambulating independently, adequate support at home. Follow up: will be completed within one month (immediate post-operative outcome). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05192044
Study type Interventional
Source National Cancer Institute, Egypt
Contact Yasser A Debakey, Lecturer
Phone 01001340579
Email [email protected]
Status Recruiting
Phase N/A
Start date December 25, 2021
Completion date July 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Recruiting NCT05048524 - Peri-operative SLOG for Localized Pancreatic Cancer Phase 2
Recruiting NCT05124743 - HLA Typing and Tumor Neoantigen Identification for a Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT04851106 - Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
Enrolling by invitation NCT04466189 - Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Recruiting NCT01411072 - Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer N/A
Active, not recruiting NCT01448668 - Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV) N/A
Completed NCT01155882 - Registry Study - Whipple at the Splenic Artery
Recruiting NCT04970056 - Pancreatic Cancer Early Detection Consortium
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1
Active, not recruiting NCT03682744 - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) Phase 1
Recruiting NCT05155878 - Prognostic Factors in Periampullary Tumors and Cysts
Recruiting NCT04920019 - Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery N/A
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes Phase 2
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Leukapheresis for CAR T- Cell Manufacturing
Recruiting NCT05068752 - Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer Phase 2
Recruiting NCT04592393 - Pancreas Cancer Surveillance Using an Abbreviated MRI N/A
Recruiting NCT04115254 - Stereotactic Magnetic Resonance Guided Radiation Therapy N/A
Recruiting NCT04640480 - Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors Phase 1