Clinical trial NCT05088564: Efficacy of Hemi-double-stapling Technique
Official title: Pylorus-preserving Pancreaticoduodenectomy Using a Hemi-double-stapling Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periampullar Disease
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. pylorus-preserving pancreaticoduodenectomy
2. ECOG scale 0-1
3. Age \> 19
4. 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
5. patient who can understand and sign the informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Grade of delayed gastric emptying by ISGPS
timeFrame: At postoperative 21 day
Secondary outcomes:
measure: hospital stay
timeFrame: At postoperative 21 day
Other outcomes:
measure: intraperitoneal abscess
timeFrame: at postoperative 2 months
measure: Incidence of reoperation/ readmission
timeFrame: At postoperative 21 day
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: GangnamSeverance Hospital
name: Joon Seoung Park
role: PRINCIPAL_INVESTIGATOR
References: