Triangle Tip-Jet Knife used as "probe mode" can reduce the risk of mucosal damage during incision and tunneling phase of peroral endoscopic myotomy (POEM) procedures.

Peroral endoscopic myotomy (POEM) is a minimally invasive endoscopic technique for the treatment of achalasia and its use has been widely spread in recent years. The Triangle Tip-Jet (TTJ) (Olympus Triangle TipKnife-J, KD645L) has become very popular in this field and currently one of the most used knives for POEM procedures. It has the capability of knife dissection along with submucosal injection and its triangle tip shape is especially useful for pulling tissue during the myotomy phase. However, its length may be too long in situations such as tight esophagogastric junction (EGJ), narrow submucosa due to fibrosis, trimming after mucosal incision and/or less experienced endoscopists3 in which preserving the integrity of the mucosa is vitally important. Distal attachment conical caps like ST Hood (DH28GR,29CR; Fujifilm, Tokyo, Japan) are commonly used for POEM, resting the distal end of the TTJ on the cap, with only the triangular tip protruding. By using straight caps, you can get a wider view and greater maneuverability, however is more difficult to calculate the distance between the triangle tip and the distal attachment end due to its straight shape. The T-shape of the distal TTJ tip was designed for its use in an open position. In this way, while using straight caps and/or less experiences endoscopists during challenging procedures (tight EGJ, submucosal fibrosis) can make them feel unsafe during incision and/or tunneling phase. Herein, we suggest the use of the TTJ knife in "probe mode"4 to reduce the distal knife length from 4.5 mm to 0.3 mm, thus allowing a greater control of the knife tip. In addition, the TTJ probe mode can be safely used with both contact and non-contact currents, which are becoming increasingly popular in recent years.

Phase IV noninferiority controlled randomized trial to evaluate the impact on diagnostic thinking and patient management and the test-retest reproducibility of the Gaxilose test for hypolactasia diagnosis.

BACKGROUND: The diagnostic accuracy of the Gaxilose test (GT) for hypolactasia diagnosis has already been proved. The objectives of this clinical trial were to demonstrate the noninferiority of the GT compared to the hydrogen breath test (HBT) on the impact on diagnostic thinking and patient management, to evaluate the GT reproducibility with urine accumulated from 0 to 4 hours and from 0 to 5 hours and to assess test safety. METHODS: We conducted a randomized, parallel, noninferiority clinical trial. Patients with clinical symptoms suggestive of lactose intolerance were screened for inclusion and randomly assigned to the GT arm or the HBT arm of the study. The impact on diagnostic thinking and patient management was analyzed with pretest and posttest questionnaires in which the investigators indicated their estimated probability of hypolactasia diagnosis and the intended management before and after the GT or the HBT (noninferiority margin: -10%). The primary outcome of the study was the impact on diagnostic thinking, expressed as the mean of the absolute values of the differences between the pretest and posttest probabilities of hypolactasia diagnosis. Patients randomized to the GT arm performed also the retest to evaluate the reproducibility of the GT. RESULTS: A total of 147 patients were included in the intend-to-treat (ITT) population. Among them, 74 performed the HBT and 73 performed the GT. The results proved the noninferiority of the GT compared to the HBT on the impact on diagnostic thinking (ImpactGT = 31.74 ±â€Š23.30%; ImpactHBT = 24.28 ±â€Š19.87%; ΔGT-HBT = 7.46%; 95% confidence interval of ΔGT-HBT: 1.55%, infinite) and on patient management. The test-retest reproducibility was better for the GT with urine accumulated from 0 to 5 h: the intraclass correlation coefficient (ICC) was 0.5761, and the Kappa coefficient was 0.7548, indicative of substantial agreement between both tests. No serious adverse events were reported during the study. CONCLUSIONS: The GT has an impact on diagnostic thinking and patient management noninferior to that of the HBT, is reproducible and well tolerated. These results prove the clinical benefit of its use in the clinical practice (ClinicalTrials.gov identifier: NCT02636413).

Triangle Tip-Jet Knife used as “probe mode” can reduce the risk of mucosal damage during incision and tunneling phase of peroral endoscopic myotomy (POEM) procedures

Peroral endoscopic myotomy (POEM) is a minimally invasive endoscopic technique for the treatment of achalasia and its use has been widely spread in recent years. The Triangle Tip-Jet (TTJ) (Olympus Triangle TipKnife-J, KD645L) has become very popular in this field and currently one of the most used knives for POEM procedures. It has the capability of knife dissection along with submucosal injection and its triangle tip shape is especially useful for pulling tissue during the myotomy phase. However, its length may be too long in situations such as tight esophagogastric junction (EGJ), narrow submucosa due to fibrosis, trimming after mucosal incision and/or less experienced endoscopists3 in which preserving the integrity of the mucosa is vitally important. Distal attachment conical caps like ST Hood (DH28GR,29CR; Fujifilm, Tokyo, Japan) are commonly used for POEM, resting the distal end of the TTJ on the cap, with only the triangular tip protruding. By using straight caps, you can get a wider view and greater maneuverability, however is more difficult to calculate the distance between the triangle tip and the distal attachment end due to its straight shape. The T-shape of the distal TTJ tip was designed for its use in an open position. In this way, while using straight caps and/or less experiences endoscopists during challenging procedures (tight EGJ, submucosal fibrosis) can make them feel unsafe during incision and/or tunneling phase. Herein, we suggest the use of the TTJ knife in “probe mode”4 to reduce the distal knife length from 4.5 mm to 0.3 mm, thus allowing a greater control of the knife tip. In addition, the TTJ probe mode can be safely used with both contact and non-contact currents, which are becoming increasingly popular in recent years. (AU)