Clinical efficacy of EMR with submucosal injection of a fibrinogen mixture: a prospective randomized trial.
BACKGROUND
Submucosal injection is essential to performing EMR easily, and various solutions have been proposed to create a long-lasting submucosal fluid cushion.


OBJECTIVE
To assess the efficacy of a fibrinogen mixture (FM) as a submucosal injection solution.


METHODS
A prospective, randomized, controlled trial.


METHODS
At a tertiary care, academic medical center.


METHODS
A total of 72 patients with early gastric neoplasm were randomly assigned to receive EMR with submucosal injection of normal saline solution (NS) or an FM.


METHODS
We performed EMR only with a conventional method.


METHODS
En bloc resection rate, complete resection rate, complications, and other procedure-related outcomes.


RESULTS
No significant differences were observed between the 2 groups (the FM group vs the NS group) in the rates of en bloc resection (80.6% vs 88.9%), complete resection rate (86.1% vs 80.6%), and recurrence rate (3% vs 6.1%). Mean procedure time was significantly shorter in the FM group vs the NS group (11.39 +/- 3.07 minutes vs 13.93 +/- 3.26 minutes; P < .05). Mean submucosal injection volume of the FM group was significantly less than that of the NS group (9.81 +/- 2.26 mL vs 14.32 +/- 2.35 mL; P < .05). Also, additional submucosal injection to maintain elevation of the lesion was less frequently required in the FM group than in the NS group (5.6% vs 33.3%; P < .05).


CONCLUSIONS
The main limitations were the method of EMR (only included the conventional method) and the size of lesions (<30 mm), because a long-lasting submucosal fluid cushion was more important in the dissection method and larger tumors.


CONCLUSIONS
The FM is a reliable submucosal injection solution for conventional EMR.
Lee
Suck-Ho
SH
Division of Gastroenterology, Department of Internal Medicine, Soon Chun Hyang University Cheonan Hospital, 23-20 Bongmyung-dong, Cheonan, Choongnam, Republic of Korea.
Park
Jeong-Hoon
JH
Park
Do Hyun
DH
Chung
Il-Kwun
IK
Kim
Hong-Soo
HS
Park
Sang-Heum
SH
Kim
Sun-Joo
SJ
Cho
Hyun-Deuk
HD
D000230:Adenocarcinoma / Q000601:surgery; D000236:Adenoma / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005340:Fibrinogen / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005743:Gastrectomy; D005753:Gastric Mucosa / Q000473:pathology*; D005773:Gastroscopy; D006801:Humans; D007267:Injections; D007723:Korea; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D012107:Research Design; D012965:Sodium Chloride / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000601:surgery*; D016896:Treatment Outcome
D012965:Sodium Chloride; D005340:Fibrinogen