Efficacy of Hemi-double-stapling Technique

  • STATUS
    Recruiting
  • End date
    Apr 22, 2024
  • participants needed
    180
  • sponsor
    Gangnam Severance Hospital
Updated on 28 October 2021

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.

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.

Details
Condition Periampullar Disease
Treatment Hand-sewn, Hemi-double stapling
Clinical Study IdentifierNCT05088564
SponsorGangnam Severance Hospital
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

pylorus-preserving pancreaticoduodenectomy
ECOG scale 0-1
Age > 19
Appropriate organ function as below i.WBC : 2500 mm3, 14000 mm3 ii.Hemoglobin : 9.0 g/dL iii.Platelet : 100,000 mm3 iv.Total bilirubin : 2.0 mg/dL (except for occlusive jaundice) v.Creatinine : 2.0 mg/dL
patient who can understand and sign the informed consent

Exclusion Criteria

previous history of gastrectomy
ulcerative scar around ampulla of duodenum on endoscopy
previous history of upper abdomen surgery (open)
Emergency
Severe ischemic heart disease
Severe hepatic failure by liver cirrhosis or hepatitis
Severe respiratory failure that requires oxygene inhalation
Chronic renal failure that requires hemodialysis
Expecting combine resection of other organ
Immunosuppressive therapy
Accompanying cancer with potential for adverse events
Severe psychologic or neurologic disease
drug or alcohol addiction
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