Laparoscopic pancreatoduodenectomy combined with a novel self-assessment system and feedback discussion: a phase 1 surgical trial following the IDEAL guidelines.

PURPOSE: Pancreatoduodenectomy (PD) is the standard yet complicated procedure for periampullary tumors. To introduce a laparoscopic approach for PD (Lap-PD), a robust and objective assessment system to evaluate the quality of this approach is needed. We describe a phase 1 surgical trial of Lap-PD (Registration ID: UMIN000015328) as a triad of surgery, novel self-assessment system, and feedback discussion implementing the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) guidelines.
METHODS: This was a surgical phase I trial (corresponding to IDEAL stage 1) approved by the Ethics Committee of our hospital. The resection sequence was divided into 10 parts that were assessed and classified into one of four grades of achievement. Evaluation of each part was then integrated, and the whole Lap-PD was categorized into three grades of achievement. We set discontinuance criteria based on historical surgical outcome of open PD. The previous case was discussed before each new case, and measures to overcome problems were implemented. Five patients underwent Lap-PD.
RESULTS: All Lap-PDs were completed laparoscopically and reconstructed via mini-laparotomy. One patient suffered recurrent ileus requiring re-laparotomy to resolve a severe adhesion. After 1 year, no patient suffered disease recurrence or complication. Based on the self-assessment system, four Lap-PDs were successful, whereas one was rated as feasible owing to bleeding requiring conversion of resection sequence.
CONCLUSIONS: Our triad system for evaluating Lap-PD could be a useful tool for the safe introduction and maintenance of Lap-PD.