Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy

Pancreatic Cancer Clinical Trial

Official title:

Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02954302
• Other study ID #: FAHXMU-2016-04
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2016
• Last updated: November 1, 2016
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Mingqiang Lin, Dr
• Phone: 8605922139708
• Email: 80218353[@]qq.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).

Description:

Delayed gastric emptying (DGE) is a common complication after pancreaticoduodenectomy (PD), occurring in 20% to 70% of the patients. DGE is usually not a life-threatening complication, but it contributes significantly to increased length of hospital stay, health care costs, and patient discomfort. In a recent study by Sakamoto et al, proximal Roux-en-y gastrojejunal anastomosis is associated with a reduced incidence of DGE after pylorus-resecting pancreaticoduodenectomy (PrPD); however, these results may have been biased because of the retrospective nature. Therefore, the investigators conducted the present randomized controlled trial (RCT) to evaluate the impact of the proximal Roux-en-y gastrojejunal anastomosis on reducing DGE following PrPD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who were scheduled to undergo PD and provided written informed consent.

• In the opinion of the surgeon, the subject has no medical contraindications to PD.

• At least 18 years of age.

Exclusion Criteria:

• Patients who underwent other surgical procedures than PD, such as total pancreatectomy (TP) or a palliative biliary and gastroenteric anastomosis.

• Drug abusers or alcoholics.

• Patient who have previous transabdominal surgery.

• The patient who were scheduled to undergo laparoscopic PD.

• The patient who does not want to participate the clinical trials.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Duodenal Cancer
• Duodenal Neoplasms
• Gastroparesis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• PrPD with proximal Roux-en-y gastrojejunal anastomosis
the distal antrum was divided about 1 to 2 cm proximal to the pylorus ring, preserving more than 95% of the stomach. The proximal jejunum was divided approximately 2 to 4 cm distal to the duodeno-jejunal junction. After completion of the resection, the proximal end of the first loop of jejunum was then brought through the transverse mesocolon, and the gastrojejunal anastomosis (GJA) was performed in two layers by using 3-0 PDS sutures and 4-0 silk sutures in an end-to-side fashion. The jejunum was then divided 35 to 40 cm distal to the GJA, and the distal limb was brought separately through the transverse mesocolon to be placed in the duodenal bed for reconstruction of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA).
• conventional PrPD
After completion of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA), a hand-sewn, isoperistaltic GJA was performed 25 to 30 cm distal to the HJA in two layers by using 3-0 polydioxanone (PDS) sutures and 4-0 silk sutures.

Locations

Country	Name	City	State
China	First affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University	Eastern Hepatobiliary Surgery Hospital, LanZhou University

Country where clinical trial is conducted

China, 

References & Publications (1)

Barakat O, Cagigas MN, Bozorgui S, Ozaki CF, Wood RP. Proximal Roux-en-y Gastrojejunal Anastomosis with Pyloric Ring Resection Improves Gastric Emptying After Pancreaticoduodenectomy. J Gastrointest Surg. 2016 May;20(5):914-23. doi: 10.1007/s11605-016-309 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	nonsurgical complications,rate		60 days after operation	Yes
Primary	Delayed gastric emptying,rate	The severity of DGE was classified into 3 grades (A, B, or C) according to the ISGPS's clinical criteria, based on the patient's clinical course and postoperative management, such as the need for NGT in the postoperative period or the inability to tolerate solid oral intake.; Grade A was defined as needing the NGT for more than 7 days or reinsertion of the NGT after postoperative day 3, or as being unable to tolerate a solid diet by postoperative day 7.; Grade B was defined as needing for NGT for 8 to 14 days after surgery or reinsertion of the NGT after day 7, or as being unable to tolerate a solid diet by postoperative day 14.; Grade C was defined as needing the NGT for more than 14 days or reinsertion of the NGT after day 14, or as being unable to tolerate a solid diet by day 21.	60 days after operation	Yes
Secondary	Morbidity,rate		60 days after operation	Yes
Secondary	Mortality,rate		60 days after operation	Yes
Secondary	Length of hospital stay,days		60 days after operation	Yes
Secondary	Pancreatic fistula,rate		60 days after operation	Yes
Secondary	Hemorrhage,rate		60 days after operation	Yes
Secondary	Bile leakage,rate		60 days after operation	Yes
Secondary	Intra-abdominal abscess,rate		60 days after operation	Yes
Secondary	wound infection,rate		60 days after operation	Yes