Clinical Trials Directory

Trials / Unknown

UnknownNCT05088564

Efficacy of Hemi-double-stapling Technique

Pylorus-preserving Pancreaticoduodenectomy Using a Hemi-double-stapling Technique

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
180 (estimated)
Sponsor
Gangnam Severance Hospital · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

Summary

Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an anastomosis method using a stapler. In the duodenojejunal anastomosis after PPPD, the hemi-double stapling method can be applied to preserve the pyloric branch of the vagus nerve and the branch of the right gastric artery to ensure sufficient blood supply. Ultimately, it is expected to shorten the anastomosis time as well as reduce the frequency of delayed gastric emptying. In addition, the work of physically expanding the pylorus to insert the circular anastomosis is also thought to reduce gastric emptying delay.

Detailed description

(1) Stapling technique 1. Make purse-string suture on jejunum at the point of duodenojejunostomy 2. Insert Anvil into jejunem 3. Make incision of 3-4 centimeters at anterior side of antrum 4. Long Kelly forceps are inserted into the stomach to dilate the pylorus 5. A 25 mm end-to-end anastomosis (EEA) stapler is inserted into the stomach and passed through the pylorus. 6. The needle of EEA stapler is pierced through the lower part of the stapler line where the duodenum has been resected 7. The EEA stapler is combined with the anvil and anastomosis is performed 8. The incision on the stomach is sutured through a linear stapler 9. Reinforcement suture for stapler line (2) Postoperative management * Diet build up as same manner of hand-sewn group (3) Postoperative follow-up * All postoperative complication, delayed gastric emptying, intraperitoneal abscess, postoperative pancreatic fistula, postpancreatectomy hemorrhage, hospital stay, reoperation, readmission and 2-months mortality.

Conditions

Interventions

TypeNameDescription
PROCEDUREHand-sewnDoudenojejunal anastomosis by hand-sewn method
PROCEDUREHemi-double staplingDoudenojejunal anastomosis by hemi-double-stapling method "EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm" is used for anastomosis

Timeline

Start date
2021-04-23
Primary completion
2024-04-22
Completion
2024-04-22
First posted
2021-10-22
Last updated
2022-10-25

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05088564. Inclusion in this directory is not an endorsement.