Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06175676 |
Other study ID # |
TianjinMUEH zlm |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
December 3, 2021 |
Est. completion date |
December 3, 2023 |
Study information
Verified date |
December 2023 |
Source |
Tianjin Medical University Eye Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Endoscopic dacryocystorhinostomy (En-DCR) has the advantages of less surgical trauma, shorter
time, less postoperative bleeding, faster recovery, and no skin scars. However, the success
rate of En-DCR surgery still varies greatly between 58% and 94% , and the main reason for the
failure of the surgery is the membranous closure of the anastomosis. The application of new
packing materials in dacryocystorhinostomy provides some new ways to improve the success rate
of En-DCR.
Hydroxybutyl chitosan (HBCS), with its non-toxicity, biocompatibility, biodegradability,
antibacterial, moisturizing properties, water solubility and temperature sensitivity, is
widely used in biomedicine to prevent postoperative adhesions.
5-Fluorouracil (5-FU) is an antimetabolite drug that is effective in the treatment of
keloids. The application of 5-FU in glaucoma filtration surgery has demonstrated its good
safety and efficacy. Studies have shown that antimetabolites as adjuvant therapy for DCR have
a positive impact on improving the success rate of surgery In this study, thermosensitive
hydroxybutyl chitosan will be applied to the anastomosis site of the nasal mucosal flap and
the lacrimal mucosal flap, or 0.3ml of 5-fluorouracil solution (25mg/ml) was injected into
the nasal mucosa around the anastomosis at the same time. The investigators would like to
observe the different situations of clinical symptoms, lacrimal duct flushing, endoscopy, and
bacterial flora changes in patients with chronic dacryocystitis, to compare them with the
previous intraoperative packing of gelatin sponge wrapped with thrombin and Tobramycin
Dexamethasone. Furthermore, the investigators intend to evaluate the safety and efficacy of
HBCS and 5-FU adjuvant internal En-DCR in the treatment of chronic dacryocystitis, and
provide new ideas for the adjuvant therapy of En-DCR.
Description:
Endoscopic dacryocystorhinostomy (En-DCR) has the advantages of less surgical trauma, shorter
time, less postoperative bleeding, faster recovery, and no skin scars. However, the success
rate of En-DCR surgery still varies greatly between 58% and 94% , and the main reason for the
failure of the surgery is the membranous closure of the anastomosis. The application of new
packing materials in dacryocystorhinostomy provides some new ways to improve the success rate
of En-DCR.
Hydroxybutyl chitosan (HBCS), with its non-toxicity, biocompatibility, biodegradability,
antibacterial, moisturizing properties, water solubility and temperature sensitivity, is
widely used in biomedicine to prevent postoperative adhesions.
5-Fluorouracil (5-FU) is an antimetabolite drug that is effective in the treatment of
keloids. The application of 5-FU in glaucoma filtration surgery has demonstrated its good
safety and efficacy. Studies have shown that antimetabolites as adjuvant therapy for DCR have
a positive impact on improving the success rate of surgery In this study, thermosensitive
hydroxybutyl chitosan will be applied to the anastomosis site of the nasal mucosal flap and
the lacrimal mucosal flap, or 0.3ml of 5-fluorouracil solution (25mg/ml) was injected into
the nasal mucosa around the anastomosis at the same time. The investigators would like to
observe the different situations of clinical symptoms, lacrimal duct flushing, endoscopy, and
bacterial flora changes in patients with chronic dacryocystitis, to compare them with the
previous intraoperative packing of gelatin sponge wrapped with thrombin and Tobramycin
Dexamethasone. Furthermore, the investigators intend to evaluate the safety and efficacy of
HBCS and 5-FU adjuvant internal En-DCR in the treatment of chronic dacryocystitis, and
provide new ideas for the adjuvant therapy of En-DCR.