Efficacy of Hemi-double-stapling Technique

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Periampullar Disease

Treatments: Procedure: Hand-sewn; Procedure: Hemi-double stapling

Study type: Interventional

Funder types: Other

Identifiers

NCT05088564

3-2021-0084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

I (Hand-sewn group)

Experimental group

Description:

Doudenojejunal anastomosis by hand-swen method

Treatment:

Procedure: Hand-sewn

II (Stapling group)

Active Comparator group

Description:

Doudenojejunal anastomosis by hemi-double-stapling method

Treatment:

Procedure: Hemi-double stapling