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.
Age ≥18 years, regardless of gender.
Anticipated survival ≥3 months.
Severe post-total pancreatectomy diarrhea (as per HART score).
Willing and able to provide written informed consent and complete follow-up assessments.
Uncontrolled or severe infections.
Severe infections complicated by sepsis or septicemia.
History of severe allergic reactions or known hypersensitivity to components of liquid live-bacterial enteric-coated capsules.
Pregnancy or lactation, or women of childbearing potential refusing contraceptive measures during the 15-week observation period.
Parallel
Fecal Microbiota Transplant (FMT)
Procedure/SurgeryOne course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy.
Standard Therapy
Other interventionStandard Therapy Alone
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.
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.
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.
Chemotherapy cycle delay rate
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.
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