Investigating the Effect of Intraperitoneal Administration of Exosome in Preventing Early Anastomotic Leakage in Rectal Cancer Patients Who Undergo Low Anterior Resection
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of patients with early anastomotic leakage
Study Overview
Brief Summary
The goal of this clinical trial is to assess the safety and efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes in preventing early anastomosis leak in patients undergoing low anterior resection for rectal cancer. The main question it aims to answer are
Do Mesenchymal Stem Cell-Derived Exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer?
If there is a comparison group: Researchers will compare Mesenchymal Stem Cells Derived Exosomes to placebo to see if it can prevent early anastomotic leakage.
Participants will receive intraperitoneal Mesenchymal Stem Cells Derived Exosomes at the end of their surgery.
Detailed Description
Anastomotic leakage remains one of the most severe complications following colorectal surgery, leading to increased morbidity, prolonged hospitalization, and reduced quality of life. Despite advances in surgical techniques and perioperative care, the incidence of early anastomotic leaks persists. Practical strategies to reduce this risk are crucial for improving patient outcomes.
Recent studies have highlighted the potential role of mesenchymal stem cell-derived exosomes in enhancing tissue repair and modulating inflammation. These extracellular vesicles, derived from human placenta mesenchymal stem cells (hPMSC), contain bioactive molecules such as proteins, lipids, and RNA that facilitate cellular communication and promote healing processes. Preclinical research suggests that exosomes can support anastomotic healing by reducing local inflammation.
This study aims to evaluate the safety and efficacy of intraperitoneal administration of hPMSC-derived exosomes in preventing early anastomotic leakage in patients undergoing low anterior resection (LAR) for rectal cancer. We hypothesize that the exosome treatment will significantly reduce the incidence of anastomotic leaks compared to placebo, thereby improving postoperative recovery and reducing hospital stay.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Stage II-III rectal cancer who underwent neoadjuvant chemoradiation therapy and are candidates for low anterior resection surgery
Exclusion Criteria
- •Patients who need emergency surgery (presenting with peritonitis or signs of obstruction)
- •Patients with apparent malnutrition or patients who have serum albumin levels of less than 3 g/dl
- •Patients who receive corticosteroids ( an equivalent dose of prednisolone 5 mg/day or more)
- •Patients with chronic pulmonary disease
- •Patients who need more than two units of blood transfusion perioperatively
Arms & Interventions
Mesenchymal Stem Cells Derived Exosomes
10 patients in this arm will receive Mesenchymal Stem Cells Derived Exosomes at the end of their low anterior resection surgery
Intervention: Mesenchymal Stem Cells Derived Exosomes (Biological)
Placebo
10 patients in this arm will receive placebo at the end of their low anterior resection surgery
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Number of patients with early anastomotic leakage
Time Frame: 1 month
Failed surgical anastomosis after surgery measured with interview and physical examinations in follow-up sessions in clinic
Secondary Outcomes
- Mean serum and peritoneal Interleukin-6 and Tumor necrosis factor-alpha levels in participants(1 month)
- Anastomosis integrity in Colonoscopy exam(1 month)
- Hospitalization length of stay(1 month)
Investigators
Ahmadi tafti
Assistant professor
Tehran University of Medical Sciences