By 2030, pancreatic cancer is projected to become the second leading cause of cancer-related deaths, with a 5-year survival rate below 10%. Approximately 20% of patients are diagnosed at a borderline resectable or resectable stage, and surgical resection remains the only curative option. However, total pancreatectomy (TP) often leads to severe diarrhea (incidence rate: 43.5%) due to exocrine insufficiency, and current pancreatic enzyme replacement therapy shows limited efficacy in some patients. Recent studies highlight the critical role of gut microbiota in pancreatic cancer progression and postoperative recovery. Patients with pancreatic ductal adenocarcinoma (PDAC) exhibit a 1000-fold increase in intrapancreatic bacterial load compared to normal tissues, with significantly elevated Bacteroides abundance and reduced Firmicutes and Proteobacteria in fecal samples. Postoperative dysbiosis is linked to complications; for example, diarrhea after cholecystectomy is dominated by Proteobacteria, suggesting that microbial imbalance may underlie diarrhea following TP. To address this, the study proposes fecal microbiota transplantation (FMT) via oral capsules. FMT has proven effective in treating recurrent Clostridium difficile infection by restoring healthy microbiota. This research will systematically evaluate the efficacy and safety of FMT in alleviating post-TP diarrhea through clinical indicators and 16S rDNA sequencing, offering novel insights into postoperative management of pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy.
Standard Therapy Alone
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang
Hangzhou, Zhejiang, China
Diarrhea HART Score
The Hart Diarrhea Scoring Scale assigns scores to nine categories. The total score is the sum of scores from each bowel movement on the same day, with each movement evaluated using this scale. A cumulative score of ≥12 points within 24 hours is classified as diarrhea.
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Gastrointestinal Symptom Rating Scale (GSRS)
The total score of the GSRS (Gastrointestinal Symptom Rating Scale) ranges from 0 to 78 points, with higher scores indicating more severe gastrointestinal symptoms in patients.
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Quality of Life (QoL) assessment
The maximum score is 60. A score of less than 20 indicates an extremely poor quality of life; 21-30, poor; 31-40, fair; 41-50, relatively good; and 51-60, good.
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Chemotherapy cycle delay rate
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Colonization status of intestinal beneficial flora
Stool samples were collected from patients at three time points: baseline, after 4 cycles of intervention, and after 8 cycles of intervention, for 16S rDNA sequencing.
Time frame: At baseline, completion of 4 intervention cycles, and completion of 8 intervention cycles (each cycle is 21 days)
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